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 An Investigation Of The Interaction Of GSK961081 With Inhaled Beta-Agonist And Anti-Muscarinic Drugs. (NCT00674817), a randomized phase 2 study. The primary outcome is Maximal Change in Forced Expiratory Volume in One Second (FEV1) From Baseline (Pre-dose on Day 1) in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h,12h and 24h..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00674817 |
| Phase | Phase 2 |
| Condition | Pulmonary Disease, Chronic Obstructive |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Triple |
| Enrollment | 45 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Theravance Biopharma |
| Results posted | Yes |
2. Clinical Question
Population
People with chronic obstructive pulmonary disease (COPD) were enrolled. The registry lists an enrollment of 45. The primary endpoint population was a modified per protocol population: participants who received at least one study-drug dose and had no major protocol deviations. Analyses at each time point included only participants available at that time.
Intervention
The study assessed single doses of GSK961081 at 400 microgrammes and 1200 microgrammes. After each dose, the recorded regimens included cumulative doses of salbutamol, ipratropium bromide, or placebo at 1h, 12h, and 24h. The short-acting medicines were administered using a spacer, with dosing intervals described in the registry record.
Comparator
The listed regimens pair each GSK961081 dose with salbutamol, ipratropium bromide, or placebo. Placebo add-on regimens provide a reference for the added short-acting medicines within the study's treatment conditions. Details of treatment sequence, period structure, and any washout are not reported in the registry record.
Primary question
The primary endpoint asks how maximal change in forced expiratory volume in one second (FEV1) from the pre-dose baseline compares when GSK961081 is followed by a short-acting bronchodilator or placebo. The endpoint is specified at 1h, 12h, and 24h. Numerical primary outcome estimates and inferential results are not reported in the registry record.
The stated rationale is to examine bronchodilatation after GSK961081 and after adding short-acting bronchodilators. The registry description frames the added response as an indirect assessment of the drug's beta-agonist and antimuscarinic components. That is the study's stated rationale, not a direct measurement of those components or a reported conclusion about them.
3. Trial Design
This was a phase 2 randomized, double-blind crossover study sponsored by Theravance Biopharma. The registry lists 45 participants enrolled, the study as completed, and a start date of 2008-04-01 with primary completion on 2008-10-01. The official title describes post-inhalation bronchodilatation after GSK961081 alone and after adding cumulative doses of salbutamol or ipratropium bromide in people with COPD.
The listed GSK961081 doses were 400 microgrammes and 1200 microgrammes. For each dose, the regimen descriptions include salbutamol, ipratropium bromide, and placebo add-on conditions. Salbutamol was given as three 200 microgramme doses at 20 min intervals; ipratropium bromide was given as 20 microgrammes, 20 microgrammes, and 40 microgrammes at 20 min intervals. The regimens place the cumulative doses at 1h, 12h, and 24h after GSK961081. Placebo was described as three doses at 20 min intervals at those time points.
In general, a crossover design exposes a participant to more than one treatment condition, allowing comparisons that account for stable differences between participants. The exact sequence and period arrangement are not reported in the registry record, so the specific within-participant comparisons cannot be reconstructed from the descriptions alone. Washout procedures and sequence balancing are also not reported in the registry record.
The record labels masking as triple, while the official title calls the study double-blind. Which roles were masked is not reported in the registry record. The available design description identifies randomization and crossover structure but does not give further details of the randomization procedure. These omissions matter when assessing how conditions were assigned and how risks of period or sequence effects were managed.
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.
Before assignment: A total of 44 participants were screened over period of 28 days and were enrolled in the study.
Period 1
| Stage | Total Population |
|---|---|
| STARTED | 44 |
| COMPLETED | 41 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Total Population |
|---|---|
| Withdrawal by Subject | 2 |
| Protocol Violation | 1 |
Period 2
| Stage | Total Population |
|---|---|
| STARTED | 41 |
| COMPLETED | 41 |
| NOT COMPLETED | 0 |
Period 3
| Stage | Total Population |
|---|---|
| STARTED | 41 |
| COMPLETED | 39 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Total Population |
|---|---|
| Adverse Event | 1 |
| Protocol Violation | 1 |
Period 4
| Stage | Total Population |
|---|---|
| STARTED | 39 |
| COMPLETED | 38 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Total Population |
|---|---|
| Adverse Event | 1 |
Analysis population for the primary outcome, as defined in the registry: Modified per protocol population included the participants who received at least one dose of the study drug where major deviations from the protocol had not occurred. Only those participants available at the specified time points were analyzed.
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.
Population: All subjects population included all participants who received at least one dose of the study drug.
| Characteristic | Unit | Total Population |
|---|---|---|
| Participants analysed | 44 | |
| Age, Continuous: Years | Years | 63.1 (SD 6.58) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 36 |
| Race/Ethnicity, Customized: Asian - South East Asian Heritage | Participants | 22 |
| Race/Ethnicity, Customized: Native Hawaiian or other Pacific Islander | Participants | 1 |
| Race/Ethnicity, Customized: White - White/Caucasian/European Heritage | Participants | 21 |
6. Primary Endpoint
The registry lists the primary outcome as Maximal Change in Forced Expiratory Volume in One Second (FEV1) From Baseline (Pre-dose on Day 1) in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h,12h and 24h., measured over Baseline (pre-dose on Day 1), 1h, 12h, and 24h on Day 1.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | Standard Error |
| Unit | Liters |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is maximal change in forced expiratory volume in one second (FEV1) from the pre-dose baseline on Day 1, in combination with salbutamol or ipratropium bromide. It is assessed at 1h, 12h, and 24h. FEV1 is measured by spirometry and represents the maximal amount of air forcefully exhaled in one second. The registry describes the outcome unit as liters.
FEV1 is used in this study as a measure of lung function and as an indicator of change in expiratory airflow after inhaled study treatments. Looking at change from a pre-dose baseline focuses the outcome on movement from the participant's starting measurement rather than the post-dose measurement alone. Assessing the maximal change is intended to capture the greatest recorded change within the stated assessment context; the precise calculation rule is not reported in the registry record.
The registry says the adjusted mean is presented as a least-squares mean. In general, a least-squares mean is a model-based mean adjusted for terms included in the statistical model; the model terms and adjustment variables are not reported in the registry record. The reported dispersion measure is the standard error, which describes the statistical uncertainty of an estimated mean under the fitted model. It is not the same as the spread of individual participants' FEV1 measurements.
The endpoint description identifies the measurement and schedule but does not provide the numerical least-squares means, standard errors, or comparison estimates. Therefore, the size and precision of any observed difference in FEV1 cannot be described from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clinically relevant statistical question: whether the maximal FEV1 change after GSK961081 differs across conditions that add salbutamol, ipratropium bromide, or placebo. It specifies assessment at 1h, 12h, and 24h and identifies least-squares means with standard errors as the form of the primary outcome summary. However, numerical primary endpoint results, treatment contrasts, confidence intervals, and p-values are not reported in the registry record.
Consequently, the magnitude, direction, and precision of the primary comparisons cannot be interpreted. The listed design and endpoint do not establish whether any combination produced a larger or smaller FEV1 change, nor whether differences were distinguishable from sampling variability. No claim about the size or statistical significance of a difference can be made without the corresponding estimates and inferential results.
General statistical context: an estimated mean describes the average outcome under a defined analysis, while its standard error describes uncertainty in that estimated mean. A confidence interval, if reported, would give a range of values reasonably compatible with the data and model assumptions. The registry record does not report confidence intervals for this endpoint. A standard error alone would not establish whether a treatment contrast is clinically important; interpreting a contrast also requires the contrast estimate, its uncertainty, and relevant clinical context.
The endpoint involves several treatment conditions and assessment times. Results for separate times or contrasts could tell different parts of the story, and selective attention to one comparison could give an incomplete account. The record lists 23 outcome measures and 108 analyses, but does not report the multiplicity strategy or identify a single numerical primary comparison. The primary outcome is not reduced to one comparison in the registry record.
The adverse-event information is descriptive. It lists participants with serious and other adverse events by regimen, but these counts do not establish that a study medicine caused an event. In a crossover study, participants can contribute experience under more than one condition; the group counts therefore should not be treated as independent groups of unique people. The registry does not provide event-level timing or attribution in the information, and the numerical efficacy results needed to evaluate the primary question are not reported.
9. Statistical Methods Explained
General statistical context: randomized allocation is intended to reduce systematic differences between treatment groups or conditions at assignment. In a crossover design, the same participant may contribute measurements under multiple conditions. This can improve efficiency for comparisons because stable participant characteristics are shared across conditions, but the analysis must account for repeated measurements and possible period or carryover effects. The registry identifies the trial as randomized and crossover but does not report the specific model, sequence structure, or handling of period effects.
What does a least-squares mean represent?
The primary outcome is specified as a least-squares mean. In general, this is a model-based estimate of a mean after adjustment for variables included in the statistical model. It can support comparisons that account for design or baseline terms, depending on the model. The registry does not report which covariates, repeated-measures structure, or other model terms were used. Without that information, the adjustment represented by the least-squares mean cannot be independently evaluated.
The outcome's dispersion measure is the standard error. In general, a standard error describes how much an estimated mean would vary across repeated samples under the model and sampling assumptions. It is about the precision of the mean estimate, not the range of individual FEV1 measurements. A standard error should be interpreted together with the estimate and, ideally, a contrast and confidence interval. Numerical standard errors and mean estimates are not reported in the registry record.
Why is baseline change used?
General statistical context: analyzing change from baseline expresses an outcome relative to a pre-treatment measurement. It can help account for variation in starting levels, although the properties of a change analysis depend on the model and the relationship between baseline and follow-up values. Here, the registry defines baseline as pre-dose on Day 1 and specifies maximal change in FEV1. It does not report the exact calculation used to define the maximum, or whether baseline values were also included as model covariates.
How should repeated time points be understood?
The endpoint schedule includes 1h, 12h, and 24h. These are repeated assessments in a study whose regimens also specify add-on doses at those times. General statistical context: measurements from the same participant are usually correlated rather than independent. A suitable repeated-measures analysis accounts for this correlation, but the particular covariance structure and model are not reported in the registry record. The reported analysis population could vary by time point because only participants available at the specified time points were analyzed.
Why does multiplicity matter?
General statistical context: examining multiple treatment contrasts, outcomes, or time points creates multiple opportunities to observe an apparently notable result by chance. A prespecified testing hierarchy or adjustment procedure can help control the overall false-positive risk, though the appropriate strategy depends on the scientific aims. The record lists 23 outcome measures and 108 analyses. The multiplicity strategy, test hierarchy, and whether the analyses were prespecified are not reported in the registry record. No single numerical primary comparison is reported.
What can be inferred from the sample-size information?
The registry record does not report a trial-specific sample-size justification or design assumptions. General statistical context: a sample-size calculation is a planning exercise based on assumptions about the effect to detect, variability, significance level, power, and design. It is not evidence that a study had a particular probability of finding a result after the data were collected. The record's sample-size assumptions state that planning illustrations use the observed effect and specified general assumptions; the illustration values and their underlying effect estimates are not included in the registry record for this analysis. These planning concepts should not be confused with the trial's enrolled sample or with observed power.
Overall, the record names the outcome summary type and analysis population but does not provide enough statistical detail to reproduce the primary analysis. The model specification, treatment contrasts, uncertainty intervals, hypothesis tests, and missing-data methods are not reported in the registry record. The endpoint definition can be described, but the numerical efficacy findings cannot be independently assessed from this information.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome covers maximal FEV1 change in combination with short-acting bronchodilators at 1h, 12h, and 24h. The registry also lists 23 outcome measures and 108 analyses. Because several conditions, time points, and outcomes can generate many possible comparisons, multiplicity is an important interpretive issue. General statistical context: without a prespecified testing strategy, interpreting the most striking result among many analyses can overstate the strength of evidence. The multiplicity plan, hierarchy of tests, and any adjustment are not reported in the registry record.
The primary analysis population is described as modified per protocol. It included participants who received at least one dose of study drug and had no major protocol deviations. Only participants available at the specified time points were analyzed. This means the analyzed participants could differ across assessment times. The registry does not report how many participants contributed to each primary time point, what counted as a major deviation, or how exclusions were determined.
Missing-data handling beyond analysis of those available at each time point is not reported in the registry record. General statistical context: an available-case analysis uses observed measurements and does not, by itself, resolve whether the absence of data is related to treatment, outcome, or participant characteristics. The potential impact depends on why measurements are unavailable and on the analysis model. No sensitivity analysis or imputation procedure is reported.
The registry does not report a full analysis plan, a prespecified primary contrast, or enough model detail to establish how multiplicity and incomplete repeated measurements were handled. This limits interpretation of any isolated comparison and makes the stated population definition particularly important when considering generalizability.
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 |
|---|---|---|---|
| 400 Microgrammes GSK961081 and Salbutamol | 0 | 39 | 0.0% |
| 1200 Microgrammes GSK961081 and Salbutamol | 1 | 41 | 2.4% |
| 400 Microgrammes GSK961081 and Ipratropium Bromide | 1 | 41 | 2.4% |
| 1200 Microgrammes of GSK961081 and Ipratropium Bromide | 0 | 41 | 0.0% |
| 400 Microgrammes of GSK961081 and Placebo | 0 | 40 | 0.0% |
| 1200 Microgrammes of GSK961081 and Placebo | 0 | 39 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| 400 Microgrammes GSK961081 and Salbutamol | 13 of 39 |
| 1200 Microgrammes GSK961081 and Salbutamol | 13 of 41 |
| 400 Microgrammes GSK961081 and Ipratropium Bromide | 14 of 41 |
| 1200 Microgrammes of GSK961081 and Ipratropium Bromide | 9 of 41 |
| 400 Microgrammes of GSK961081 and Placebo | 6 of 40 |
| 1200 Microgrammes of GSK961081 and Placebo | 11 of 39 |
Most frequent serious adverse event terms
| Event term | Organ system | 400 Microgrammes GSK961081 and Salbutamol | 1200 Microgrammes GSK961081 and Salbutamol | 400 Microgrammes GSK961081 and Ipratropium Bromide | 1200 Microgrammes of GSK961081 and Ipratropium Bromide | 400 Microgrammes of GSK961081 and Placebo | 1200 Microgrammes of GSK961081 and Placebo |
|---|---|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | 0 of 39 | 0 of 41 | 1 of 41 | 0 of 41 | 0 of 40 | 0 of 39 |
| Migraine with aura | Nervous system disorders | 0 of 39 | 1 of 41 | 0 of 41 | 0 of 41 | 0 of 40 | 0 of 39 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 400 Microgrammes GSK961081 and Salbutamol | 1200 Microgrammes GSK961081 and Salbutamol | 400 Microgrammes GSK961081 and Ipratropium Bromide | 1200 Microgrammes of GSK961081 and Ipratropium Bromide | 400 Microgrammes of GSK961081 and Placebo | 1200 Microgrammes of GSK961081 and Placebo |
|---|---|---|---|---|---|---|---|
| Headache | Nervous system disorders | 5 of 39 | 5 of 41 | 4 of 41 | 4 of 41 | 1 of 40 | 3 of 39 |
| Nasopharyngitis | Infections and infestations | 1 of 39 | 1 of 41 | 2 of 41 | 0 of 41 | 1 of 40 | 2 of 39 |
| Tremor | Nervous system disorders | 1 of 39 | 2 of 41 | 1 of 41 | 1 of 41 | 0 of 40 | 0 of 39 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 39 | 1 of 41 | 3 of 41 | 0 of 41 | 0 of 40 | 0 of 39 |
| Hypokalaemia | Metabolism and nutrition disorders | 0 of 39 | 3 of 41 | 0 of 41 | 0 of 41 | 0 of 40 | 1 of 39 |
| Dysgeusia | Nervous system disorders | 0 of 39 | 1 of 41 | 0 of 41 | 1 of 41 | 0 of 40 | 1 of 39 |
| Diarrhoea | Gastrointestinal disorders | 0 of 39 | 1 of 41 | 0 of 41 | 1 of 41 | 1 of 40 | 0 of 39 |
| Dyspepsia | Gastrointestinal disorders | 1 of 39 | 0 of 41 | 0 of 41 | 0 of 41 | 1 of 40 | 0 of 39 |
| Nausea | Gastrointestinal disorders | 0 of 39 | 1 of 41 | 1 of 41 | 0 of 41 | 0 of 40 | 0 of 39 |
| Vomiting | Gastrointestinal disorders | 0 of 39 | 0 of 41 | 1 of 41 | 1 of 41 | 0 of 40 | 0 of 39 |
Serious events with the highest arm-level rate: angina pectoris (2.4%), migraine with aura (2.4%).
The safety listings give, for each regimen, the number of participants at risk and the number affected by serious adverse events and by other adverse events. For serious adverse events, the pairs are 0 of 39 with 400 Microgrammes GSK961081 and Salbutamol; 1 of 41 with 1200 Microgrammes GSK961081 and Salbutamol; 1 of 41 with 400 Microgrammes GSK961081 and Ipratropium Bromide; 0 of 41 with 1200 Microgrammes of GSK961081 and Ipratropium Bromide; 0 of 40 with 400 Microgrammes of GSK961081 and Placebo; and 0 of 39 with 1200 Microgrammes of GSK961081 and Placebo.
These are counts of participants recorded as affected within each regimen, not a comparison adjusted for the crossover design. Participants may have contributed to more than one regimen, so the groups should not be read as mutually exclusive sets of people. The small counts are descriptive and do not establish a causal relationship or a comparative safety difference.
The registry lists Angina pectoris and Migraine with aura as the top serious-event terms, each reported as 2.4%. The information available does not identify their treatment allocation or establish attribution. Death counts are not reported in the registry record. The other adverse-event counts and laboratory or physiological outcomes are listed separately; these should not be interpreted as the same category as serious adverse events.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized crossover investigation of GSK961081 at 400 microgrammes and 1200 microgrammes, followed by salbutamol, ipratropium bromide, or placebo. Its primary endpoint is maximal change in FEV1 from pre-dose baseline at 1h, 12h, and 24h. This establishes the question and planned measurement, but does not establish the direction or size of an observed treatment difference.
Numerical primary endpoint estimates and inferential results are not reported in the registry record. Therefore, the posted information does not support a conclusion about whether FEV1 differed across regimens, how precise any difference was, or whether a difference was statistically compatible with no effect. It also does not permit assessment of clinical importance. Those judgments require the relevant estimates, uncertainty, and context, none of which are present in the record information used.
The record's rationale describes the added short-acting bronchodilators as an indirect way to assess the pharmacological components of GSK961081. Even with numerical results, such an indirect assessment would need to be interpreted in light of the design and analysis. The record does not report results that would demonstrate a specific component's contribution.
Likewise, safety counts describe recorded events in the listed regimens; they do not prove that an event was caused by a treatment or establish a definitive difference in risk. Crossover participants may appear in more than one regimen's counts, and the listed serious-event counts are limited. The study's enrollment and endpoint definitions alone cannot establish generalizability beyond the analyzed population.
In short, the registry gives a clear outline of the clinical question, design, endpoint, analysis population, and safety categories. It does not report the numerical efficacy findings needed to answer the primary comparison, nor enough statistical detail to reconstruct the analysis. No efficacy or comparative safety conclusion should be drawn from the design description alone.
13. Why This Trial Matters Statistically
This trial is statistically interesting because it combines a crossover structure with repeated lung-function assessments and add-on treatment conditions. Crossover comparisons can use each participant's measurements across conditions, potentially reducing the influence of stable differences between participants. At the same time, valid interpretation depends on how treatment sequence, period effects, within-participant correlation, and possible carryover are handled. Those analytical details are not reported in the registry record.
The outcome also has a repeated schedule: maximal FEV1 change is specified at 1h, 12h, and 24h, with the add-on regimens administered at those times. Multiple assessments can describe response over time, but they also create multiple comparisons and a need for a clear testing strategy. The record lists 23 outcomes and 108 analyses, while its primary endpoint is not reduced to one numerical comparison. That makes transparent reporting of the analysis plan and uncertainty especially important.
The distinction between a least-squares mean and an individual measurement is another useful statistical point. A model-based mean can be adjusted for specified terms, but readers need to know which terms were used and how repeated observations were modeled. The record identifies the mean type and standard error but does not report the model details or the numerical estimates.
Finally, the trial shows why registry endpoint descriptions and registry results are different kinds of evidence. A defined endpoint specifies what investigators intended to measure; it does not reveal the observed treatment contrast. In this case, the available record supports discussion of design and measurement but not a numerical efficacy interpretation. The safety data can be read descriptively, with caution about overlapping participants and sparse serious-event counts.
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 main limitation for statistical interpretation is that numerical primary endpoint results are not reported in the registry record. The least-squares means, standard errors, treatment contrasts, confidence intervals, and p-values are unavailable in the information used for this analysis. As a result, the primary comparison's magnitude, direction, and precision cannot be evaluated.
The design description does not include treatment sequence or period details, washout procedures, or methods for addressing possible carryover. The registry labels the study triple-masked, while its official title describes it as double-blind; the masked roles are not reported in the registry record. The randomization procedure is also not described beyond identifying the study as randomized.
Analysis details are limited. The record identifies a modified per protocol population and says that only participants available at a specified time point were analyzed. It does not report time-specific analysis counts, reasons for missing measurements, imputation or sensitivity analyses, model terms, or the repeated-measures covariance structure. The handling of multiple endpoints, time points, and analyses is not reported.
The safety counts are descriptive and are not presented with treatment attribution or event timing in the information available. Since this is a crossover study, counts under different regimens may include the same participants. The serious-event counts are small, and the registry does not report deaths in the available record. These data do not support strong comparative safety conclusions.
Finally, the registry describes the endpoint and analysis population but does not report a trial-specific sample-size justification. The enrolled sample of 45 is not, by itself, evidence of adequate precision for any particular comparison. Conclusions are therefore constrained by missing numerical results and limited analysis detail, rather than by the endpoint definition alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Investigation Of The Interaction Of GSK961081 With Inhaled Beta-Agonist And Anti-Muscarinic Drugs. — NCT00674817.
- Registry record last updated 2021-10-20; status last verified 2021-09.
- Results first posted 2017-03-27.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
NCT00674817 is a completed phase 2 randomized, double-blind crossover study sponsored by Theravance Biopharma. It enrolled 45 people with COPD and examined GSK961081 at 400 microgrammes and 1200 microgrammes with cumulative add-on doses of salbutamol, ipratropium bromide, or placebo.
The primary endpoint was maximal change in FEV1 from pre-dose baseline at 1h, 12h, and 24h, summarized as a least-squares mean with standard error. The modified per protocol population included treated participants without major protocol deviations, with only those available at each time point analyzed.
The record lists serious and other adverse-event counts by regimen, along with additional safety outcomes. It does not report numerical primary endpoint estimates, inferential results, detailed model specifications, or the multiplicity and missing-data strategies. The available information therefore describes the study question and methods but does not permit a numerical interpretation of the primary efficacy comparison.