This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Clinical Study With Fluticasone Furoate Nasal Spray And Vehicle Placebo For The Treatment Of Perennial (Year-round) Allergic Rhinitis (NCT00682643), a randomized phase 4 study. The primary outcome is Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00682643 |
| Phase | Phase 4 |
| Condition | Rhinitis, Allergic, Perennial |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 550 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
Adults and adolescents 12 years of age and older with perennial allergic rhinitis were eligible. The registry record describes an intended enrollment of 550 participants and identifies the condition as perennial allergic rhinitis. The primary analysis population is described as participants with post-baseline ophthalmic examination data.
Intervention
Participants assigned to the active-treatment group received fluticasone furoate nasal spray. The official title specifies once-daily use of 110 mcg. The registry’s safety-group label is “FF 110 mcg QD.”
Comparator
The comparator was vehicle placebo nasal spray. The registry lists placebo as a drug intervention and labels its safety group “Placebo.”
Primary question
The primary endpoint asked how often participants experienced a prespecified increase in posterior subcapsular lens opacity in either eye during follow-up. An event was an increase of at least 0.3 from baseline on the LOCS III grading scale. The endpoint was expressed as a cumulative percentage estimated using Kaplan–Meier methods. The numerical endpoint results and a treatment comparison are not reported in the registry record.
This clinical question is framed around long-term ocular safety, as stated in the registry’s study purpose and official title. It is not a direct measure of allergic-rhinitis symptom improvement. The primary endpoint concerns a particular lens-opacity change, while the listed secondary outcomes include other ocular measurements, such as cortical and nuclear opacity and intraocular pressure. These outcomes describe different aspects of ocular examination and should not be treated as interchangeable measures.
The study record describes random assignment to fluticasone furoate nasal spray or vehicle placebo and double masking. Those design features are intended to support a fair comparison and limit the influence of participants’ or investigators’ knowledge of assignment. The endpoint’s interpretation still depends on the actual event counts, follow-up, censoring, and analysis details. The primary numerical findings needed to assess the observed comparison are not reported in the registry record.
3. Trial Design
This was a phase 4, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Its official title describes a two-year evaluation of ocular safety in adults and adolescents 12 years of age and older with perennial allergic rhinitis. The registry lists an intended enrollment of 550 and marks the study as completed. The study start is recorded as 2008-06 and primary completion as 2011-02.
The two interventions were fluticasone furoate nasal spray and vehicle placebo nasal spray. The official title specifies once-daily fluticasone furoate nasal spray at 110 mcg. The arm descriptions in the registry are blank, so further details about how the interventions were administered are not reported in the registry record. Randomization indicates that assignment was intended to be determined by chance; double masking indicates that the record characterizes the study as masked, but does not specify which roles were masked.
The parallel-group structure means participants were assigned to one group rather than being described as crossing between treatments. A placebo comparator can help distinguish observed outcomes in the active-treatment group from outcomes under the study’s vehicle placebo condition. General statistical context: randomization can reduce systematic differences between groups at baseline on average, while masking can limit some behavioral and assessment influences. Neither feature by itself guarantees complete follow-up or eliminates uncertainty in an estimated treatment difference.
The primary endpoint followed participants’ cumulative occurrence of a posterior subcapsular opacity event over scheduled assessments extending to Week 104. The registry lists baseline and follow-up time points at Weeks 12, 24, 36, 52, 64, 76, 88, and 104. Secondary outcomes include changes in several LOCS III opacity and color measures and intraocular pressure. There are 14 outcome measures listed in the record. The full protocol, recruitment details, randomization procedure, allocation concealment, and operational description of masking are not reported in the registry record.
The primary outcome results are not reported in the registry record, so the completed status and planned enrollment do not establish what was observed for the endpoint. The study’s completion status also does not establish that every randomized participant completed follow-up. Participant flow and the number contributing endpoint data at each assessment are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Placebo | FF 110 mcg QD |
|---|---|---|
| STARTED | 182 | 368 |
| COMPLETED | 104 | 199 |
| NOT COMPLETED | 78 | 169 |
Reasons for not completing this period:
| Reason | Placebo | FF 110 mcg QD |
|---|---|---|
| Adverse Event | 12 | 23 |
| Lack of Efficacy | 2 | 0 |
| Protocol Violation | 38 | 76 |
| Met Protocol-defined Stopping Criteria | 3 | 4 |
| Lost to Follow-up | 1 | 6 |
| Physician Decision | 2 | 6 |
| Withdrawal by Subject | 19 | 53 |
| Did Not Receive Study Drug | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: ITT Population. All participants (par.) with post-baseline ophthalmic examination data were included in the analysis for this endpoint. Par. without post-baseline ophthalmic exam data were censored at the randomization data. Par. who completed the study without an event for P or were discontinued for reasons other than an event for P were censored.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Placebo | FF 110 mcg QD | Total |
|---|---|---|---|---|
| Participants analysed | 181 | 367 | 548 | |
| Age, Continuous | Years | 38.0 (SD 13.34) | 37.0 (SD 13.48) | 37.4 (SD 13.43) |
| Gender: Female | Participants | 116 | 255 | 371 |
| Gender: Male | Participants | 65 | 112 | 177 |
| Race/Ethnicity, Customized: African American/African Heritage | participants | 29 | 50 | 79 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | participants | 1 | 4 | 5 |
| Race/Ethnicity, Customized: Central/South Asian Heritage | participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Japanese/East Asian/South East Asian Heritage | participants | 2 | 6 | 8 |
| Race/Ethnicity, Customized: Mixed Asian Heritage | participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Native Hawaiian or other Pacific Islander | participants | 2 | 2 | 4 |
| Race/Ethnicity, Customized: White | participants | 146 | 303 | 449 |
| Race/Ethnicity, Customized: African American/African Heritage & White | participants | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P), measured over Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was the cumulative proportion of participants with an event for posterior subcapsular opacity, expressed as a percentage. The event definition was an increase of at least 0.3 from baseline in the LOCS III grade for posterior subcapsular opacity in either eye. LOCS III is described in the registry as a system for grading and comparing cataract severity and type using standard color photographic transparencies. The stated grade range runs from 0.1, described as lens clear, to 5.9, described as lens unclear.
The endpoint is cumulative: it concerns whether an event has occurred by each point in follow-up, rather than only the measurement at one visit. The listed timeframe includes baseline and assessments through Week 104. The registry says the cumulative proportion was estimated using a Kaplan–Meier life-table method. This approach is commonly used for time-to-event outcomes because it can incorporate information from participants whose event status is not observed for the entire follow-up, provided censoring is handled according to the analysis plan.
General context: a prespecified change threshold can make an endpoint less dependent on tiny measurement fluctuations than a definition based on any detectable change. A thresholded endpoint nevertheless reduces a graded measurement to whether a participant crosses a chosen boundary. The resulting estimate does not describe every change in opacity or establish the cause of a change.
The registry’s endpoint description identifies the analysis population as participants with post-baseline ophthalmic examination data. It says participants without post-baseline examinations were censored at randomization. Further details of the endpoint results, including the numerical cumulative estimates and uncertainty intervals, are not reported in the registry record. Consequently, the size and precision of the observed group comparison cannot be assessed from the registry entry.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically focused safety question: whether participants experienced a defined increase in posterior subcapsular lens opacity during follow-up. The event threshold was an increase of at least 0.3 from baseline on the LOCS III scale in either eye. The record specifies a cumulative percentage estimated by Kaplan–Meier methods, with observations scheduled through Week 104. It does not report the primary endpoint estimates, the group-specific event counts, a treatment contrast, a confidence interval, or a p-value. There is therefore no registry result from which to describe the magnitude or precision of the primary comparison.
The endpoint is not an overall measure of ocular health or a measure of allergic-rhinitis control. A result for this particular event would speak to the frequency of crossing its specified opacity threshold under the study’s follow-up and analysis approach. It would not, on its own, summarize all the secondary ocular outcomes, determine the cause of an individual participant’s change, or address outcomes not measured by the study.
The record also lists ocular secondary outcomes: changes in posterior subcapsular, cortical, and nuclear opacity, nuclear color, and intraocular pressure. Some outcomes are described as changes from baseline and others as counts meeting specified change increments. Their results are not included in the registry record described by the registry entry. They should not be inferred from the primary endpoint definition or from the adverse-event figures.
There are safety figures for serious and other adverse events. In the Placebo group, the record lists 7 participants with serious adverse events among 181 at risk and 97 with other adverse events among 181 at risk. In the FF 110 mcg QD group, it lists 12 participants with serious adverse events among 367 at risk and 232 with other adverse events among 367 at risk. These are descriptive counts with group denominators, not the primary ocular endpoint. The registry does not report a statistical comparison or uncertainty interval for these figures in the registry record for this analysis.
General statistical context: a confidence interval communicates the range of effect values compatible with the observed data under the specified method, while a p-value addresses compatibility with a null hypothesis under statistical assumptions. Neither is a substitute for the estimate itself, and neither establishes clinical importance. Since the primary estimate and its uncertainty are not reported in the registry record, the statistical strength of evidence for the primary comparison cannot be evaluated.
The study’s randomized, masked design is relevant to how a comparison could be interpreted, but design labels alone do not reveal whether groups remained comparable throughout follow-up or how missing examinations affected the analysis. The registry states that participants without post-baseline ophthalmic examination data were censored at randomization, but the fuller handling of discontinuations and other missing data is not reported in the registry record. Interpretation should therefore remain limited to the study question, endpoint definition, design, and safety counts that are explicitly recorded.
9. Statistical Methods Explained
The primary outcome is a time-to-event outcome summarized as a cumulative percentage. A participant met the event definition upon an increase of at least 0.3 from baseline in LOCS III posterior subcapsular opacity grade in either eye. The registry reports use of a Kaplan–Meier estimate based on a life-table approach. This differs from a simple proportion calculated by dividing the number of observed events by the number enrolled: the Kaplan–Meier method uses event timing and accounts for participants whose observation ends before the full follow-up period.
What does censoring mean for this endpoint?
General statistical context: censoring occurs when an individual’s event time is not fully observed during the analysis period. A participant may be known to have remained event-free through the last available examination without it being known whether an event would occur later. A time-to-event method can retain information through that last observation rather than treating the participant as if the entire follow-up had been observed. The validity of the estimate depends on the censoring process and the analysis assumptions. The registry states that participants without post-baseline ophthalmic examination data were censored at randomization. It also says participants who completed the study without an event or were discontinued, but the description ends before the complete handling is available. Additional censoring rules are not reported in the registry record.
Why report a cumulative estimate?
A cumulative estimate describes the proportion experiencing an event over follow-up, rather than only comparing measurements at a single visit. This can be useful when participants have different lengths of observation or when the event may arise at different times. The reported timeframe includes assessments through Week 104, with intermediate scheduled visits. The estimate remains dependent on adequate event ascertainment and appropriate handling of censoring. The registry’s endpoint description does not give the numerical estimates at the listed visits, so the time pattern cannot be characterized.
What does the event threshold capture?
The endpoint converts a continuous grading measure into an event indicator based on a prespecified increase from baseline. General statistical context: threshold-based outcomes can be easier to interpret as the proportion crossing a defined boundary, but they discard information about the size of changes that remain below the threshold and the degree by which changes exceed it. The registry describes LOCS III as a photographic grading system for cataract severity and type. It does not report measurement reproducibility, assessor training, or other details that would help evaluate measurement variability.
What can a confidence interval contribute?
General statistical context: a confidence interval describes uncertainty around an estimate under a specified statistical procedure. A narrow interval generally indicates greater precision than a wide interval, while an interval spanning values on both sides of a null comparison may be compatible with a range of conclusions. Such an interval does not by itself determine whether an effect matters clinically. The primary endpoint’s confidence interval and numerical comparison are not reported in the registry record, so precision cannot be assessed.
Why can over-dispersion matter?
General statistical context: over-dispersion means that observed variability is greater than a model’s assumptions allow. If a model ignores that extra variability, its uncertainty estimates may be too small. The primary endpoint is described as a Kaplan–Meier cumulative estimate, not as a count model with a stated dispersion parameter. No over-dispersion assessment or model-based adjustment is reported in the registry record, and no such procedure should be assumed.
What do the planning illustrations mean?
The planning illustrations are described as calculations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect to detect is expressed as a fraction of the observed effect. For time-to-event outcomes, the stated planning quantity is total events; for other outcomes, it is participants per arm. These are planning illustrations, not observed power and not evidence that the study was designed using those assumptions. The registry does not report its own sample-size justification or design calculation. The primary outcome has several categories or time points and was not reduced to one comparison for this purpose, so a single endpoint comparison should not be inferred from the illustrations.
General context: a post-study sample-size calculation based on an observed effect is sensitive to that estimate and does not independently validate the finding. It is best read as an illustration of what a future design might require under stated assumptions, not as a summary of how likely the completed trial was to detect an effect. The registry does not report the full numerical planning outputs in the registry record for this analysis.
The registry does not report the full statistical analysis plan, model specifications beyond the Kaplan–Meier description, covariate adjustments, confidence-interval method, formal hypothesis test, or interim analyses. The actual analysis choices and their implications therefore cannot be reconstructed from the record description.
10. Multiplicity, Missing Data and Analysis Populations
The record lists 14 outcome measures, including the primary posterior subcapsular opacity endpoint and secondary measures of several lens characteristics and intraocular pressure. The primary endpoint itself is described over multiple scheduled assessment times, and some secondary outcomes include multiple change thresholds or increments. Examining multiple outcomes, times, or thresholds can raise a multiplicity issue: when many statistical tests are performed, the chance of at least one apparently unusual result can increase. General statistical context: investigators may address this through a prespecified testing hierarchy, an adjustment method, or careful interpretation of exploratory results. The registry does not report a multiplicity procedure or testing hierarchy.
The primary analysis population is described as participants with post-baseline ophthalmic examination data. Participants without post-baseline ophthalmic examination data were censored at randomization. The record also mentions participants who completed the study without an event or were discontinued, but the description is incomplete. More detail about how those cases entered the analysis is not reported in the registry record.
Missing examination data can affect a time-to-event analysis because the last observed assessment may determine how much follow-up contributes. General statistical context: censoring methods rely on assumptions about the relationship between the reason observation ends and the chance of experiencing the event. If those assumptions are not reasonable, estimates may be affected. The registry does not report reasons for missing examinations, the amount of missing data by group, sensitivity analyses, or methods for assessing the impact of missingness.
The record does not report a detailed analysis plan, whether analyses followed assignment regardless of treatment received, or how deviations and discontinuations were handled. Although it names an ITT Population, its accompanying description specifically identifies participants with post-baseline ophthalmic examination data for this endpoint. The scope of that population and the handling of participants without such data should therefore be read as described, not expanded by assumption. No interim analyses, multiplicity adjustment, or missing-data sensitivity method should be presumed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Placebo | 7 | 181 | 3.9% |
| FF 110 mcg QD | 12 | 367 | 3.3% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo | 97 of 181 |
| FF 110 mcg QD | 232 of 367 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | FF 110 mcg QD |
|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | 0 of 181 | 2 of 367 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 2 of 181 | 0 of 367 |
| Contusion | Injury, poisoning and procedural complications | 0 of 181 | 1 of 367 |
| Rib fracture | Injury, poisoning and procedural complications | 0 of 181 | 1 of 367 |
| Tibia fracture | Injury, poisoning and procedural complications | 0 of 181 | 1 of 367 |
| Upper limb fracture | Injury, poisoning and procedural complications | 0 of 181 | 1 of 367 |
| Cerebral haemorrhage | Nervous system disorders | 0 of 181 | 1 of 367 |
| Convulsion | Nervous system disorders | 0 of 181 | 1 of 367 |
| Grand mal convulsion | Nervous system disorders | 0 of 181 | 1 of 367 |
| Intra-uterine death | Pregnancy, puerperium and perinatal conditions | 1 of 181 | 0 of 367 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | FF 110 mcg QD |
|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 34 of 181 | 123 of 367 |
| Upper respiratory tract infection | Infections and infestations | 29 of 181 | 52 of 367 |
| Sinusitis | Infections and infestations | 31 of 181 | 47 of 367 |
| Nasopharyngitis | Infections and infestations | 17 of 181 | 44 of 367 |
| Headache | Nervous system disorders | 13 of 181 | 29 of 367 |
| Influenza | Infections and infestations | 16 of 181 | 25 of 367 |
| Viral upper respiratory tract infection | Infections and infestations | 12 of 181 | 27 of 367 |
| Bronchitis | Infections and infestations | 8 of 181 | 31 of 367 |
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | 3 of 181 | 30 of 367 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 9 of 181 | 23 of 367 |
Serious events with the highest arm-level rate: arthralgia (1.1%), intra-uterine death (0.6%), upper airway obstruction (0.6%), cholelithiasis (0.6%), suicide attempt (0.6%).
The registry lists serious adverse-event counts and other adverse-event counts by group. For Placebo, 7 participants were affected by serious adverse events among 181 at risk, and 97 were affected by other adverse events among 181 at risk. For FF 110 mcg QD, 12 participants were affected by serious adverse events among 367 at risk, and 232 were affected by other adverse events among 367 at risk. These are participant counts and the corresponding at-risk denominators as recorded, not the primary lens-opacity endpoint.
The registry lists Arthralgia at 1.1%, and Intra-uterine death, Upper airway obstruction, Cholelithiasis, Suicide attempt, and Nephrolithiasis each at 0.6% among the top serious adverse-event terms. The record does not specify a group attribution for these terms in the registry record. Death counts are not reported in the registry record.
General statistical context: adverse-event counts describe events observed and recorded during the study; they do not by themselves establish that an intervention caused an event. Interpretation depends on definitions, exposure and follow-up, event ascertainment, and the comparison being made. The registry figures do not include confidence intervals or a statistical test for these group counts. The serious and other adverse-event categories should also not be combined or treated as equivalent. No conclusion about comparative safety should be drawn from the counts alone.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed, randomized, double-blind, placebo-controlled, parallel-group study was intended to evaluate long-term ocular safety of once-daily fluticasone furoate nasal spray 110 mcg in adults and adolescents with perennial allergic rhinitis. It defines a primary event based on an increase of at least 0.3 from baseline in LOCS III posterior subcapsular opacity grade in either eye and describes a Kaplan–Meier cumulative estimate through Week 104. These details clarify the question and the intended method, but they do not supply the primary result.
The primary numerical estimates, group comparison, uncertainty intervals, and p-value are not reported in the registry record. The record therefore does not establish the observed frequency of the primary event in either group or how precisely a comparison was estimated. It is not possible to characterize the direction or size of the primary endpoint result from the available the registry entries.
The safety record includes serious and other adverse-event counts, as well as selected serious adverse-event terms. Those figures are descriptive and are not a substitute for the primary ocular endpoint or for a full comparative safety analysis. The registry entries do not provide statistical uncertainty for those counts or a causal assessment of individual events.
General statistical context: a study design can support a planned comparison, but its conclusions depend on the observed data, completeness of follow-up, endpoint measurement, and analysis. Randomization and masking are important design features, but they do not reveal the results or remove uncertainty. A completed status means the registry marks the study completed; it does not by itself show that every participant completed follow-up or that a particular outcome was observed.
The record also does not provide the full statistical analysis plan, the sponsor’s sample-size justification, interim-analysis details, or complete missing-data procedures. The sample-size material is described as a planning illustration based on an observed effect, not as the original design justification or observed power. Overall, the available record describes the study question, core design, endpoint definition, and selected safety counts, but the efficacy-style numerical summary needed to judge the primary endpoint comparison is not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable for asking a long-term safety question with a time-to-event endpoint rather than relying only on a single examination measurement. The primary outcome treats a prespecified change in posterior subcapsular opacity as an event and summarizes its cumulative occurrence over follow-up. The registry identifies a sequence of assessments extending to Week 104 and describes a Kaplan–Meier life-table estimate. This makes follow-up and censoring central to how the primary quantity is interpreted.
The endpoint also illustrates a common trade-off in clinical measurement. A threshold can define an event that is straightforward to count, while converting a graded LOCS III measure into an event indicator loses detail about changes that do not cross the threshold. The endpoint’s meaning therefore depends both on the grading measure and on the event definition. The record specifies the threshold but does not report further measurement-performance details.
The randomized, masked, placebo-controlled design is relevant to a comparative safety question. General statistical context: randomization helps balance measured and unmeasured baseline characteristics in expectation, while masking can reduce some influences on reporting and assessment. Evaluating the strength of a result still requires the actual event estimates, uncertainty, completeness of follow-up, and analysis methods. Those primary result details are not reported in the registry record.
The record lists multiple ocular outcomes and multiple assessment times. That breadth can provide information about different aspects of ocular status, but it also makes the analysis plan and multiplicity handling important. Neither a hierarchy of outcomes nor a multiplicity adjustment is reported. The study is also an example of why registry design information and posted numerical results need to be distinguished: the record describes the intended question and approach, while it does not supply the primary outcome comparison needed to quantify what was observed.
The adverse-event counts contribute descriptive safety information, but they answer a different question from the primary lens-opacity endpoint. Keeping endpoint definitions and evidence types distinct prevents a count in one category from being interpreted as a result for another.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpretation is that the primary endpoint’s numerical results are not reported in the registry record. There are no group-specific cumulative estimates, event counts, treatment contrast, confidence interval, or p-value in the registry record. Without these, the direction, magnitude, and precision of the primary comparison cannot be assessed.
The endpoint description says participants without post-baseline ophthalmic examination data were censored at randomization, but the remainder of the population and censoring description is incomplete. Reasons for missing examinations, follow-up completeness by group, and sensitivity analyses are not reported. These details matter for a time-to-event estimate because the amount and pattern of observed follow-up influence how the data contribute.
Although the registry names an ITT Population, the endpoint description also limits inclusion to participants with post-baseline ophthalmic examination data. Further information about this population definition and treatment of participants lacking such data is not reported. Participant flow, group-specific numbers assessed at each visit, and protocol deviations are also not reported in the registry record.
The registry lists multiple secondary outcomes and time points but does not describe a multiplicity strategy or a prespecified testing hierarchy. The complete statistical analysis plan, interim analyses, model details beyond the Kaplan–Meier description, and the sponsor’s sample-size justification are not reported. The planning material is characterized as an illustration based on the observed effect, not as evidence of the original design rationale or observed power.
The adverse-event figures are descriptive counts without reported uncertainty intervals or statistical comparisons in the registry record used. The registry does not specify attribution for the listed serious-event terms in the registry record. The arm descriptions are blank, and operational details about allocation concealment, masking roles, and treatment administration are not reported. These limitations restrict interpretation to the stated design, endpoint definition, and recorded safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Clinical Study With Fluticasone Furoate Nasal Spray And Vehicle Placebo For The Treatment Of Perennial (Year-round) Allergic Rhinitis — NCT00682643.
- Registry record last updated 2017-01-13; status last verified 2016-11.
- Results first posted 2012-03-13.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT00682643 is a completed phase 4, randomized, double-blind, placebo-controlled, parallel-group, multicenter study of fluticasone furoate nasal spray and vehicle placebo in adults and adolescents 12 years of age and older with perennial allergic rhinitis. The official title describes once-daily fluticasone furoate nasal spray 110 mcg and a two-year ocular-safety evaluation. The registry records enrollment of 550, a study start of 2008-06, and primary completion of 2011-02.
The primary endpoint was the cumulative percentage with a posterior subcapsular opacity event, defined by an increase of at least 0.3 from baseline in LOCS III grade in either eye and estimated using Kaplan–Meier methods. The endpoint results are not reported in the registry record. The record lists 14 outcome measures, including secondary ocular measures, and provides descriptive serious and other adverse-event counts by group.
Further details about the complete analysis plan, multiplicity, the full missing-data approach, and the sponsor’s original sample-size justification are not reported in the registry record. The available information describes the study design and endpoint but does not permit assessment of the primary treatment comparison’s size or precision.