Trial · NCT00812929
A Clinical Trial to Test a Study Drug in Volunteers Who Develop Asthma Following Exercise
NCT00812929, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-09-19
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ConductScience Library. A Clinical Trial to Test a Study Drug in Volunteers Who Develop Asthma Following Exercise. Trials, record NCT00812929. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00812929
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial to Test a Study Drug in Volunteers Who Develop Asthma Following Exercise
- NCT number
- NCT00812929
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- Placebo, GSK2190915
- First posted
- 2008-12-22
- Last updated
- 2017-09-19
- Results first posted
- 2017-09-19
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose | Baseline (pre dose) and 60 minutes following the exercise challenge at 24 hours post dose of each treatment period. | FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge. The maximal percentage change within 60 minutes following exercise challenge was derived by taking minimum (i.e., most negative) percentage change in FEV1 over 5, 10, 15, 30, 45 and 60 minutes post challenge. Percent change FEV1 = 100\*(FEV1 - Pre-challenge FEV1)/ Pre-challenge FEV1. If the exercise challenge was not completed successfully (i.e. heart rate maintained at \>=80% of the predicted value for 6 minutes), FEV1 maximal percent change (0-60)was set to be missing. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated. |
| Secondary | Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | Baseline (pre dose) and 60 minutes following the exercise challenge at 2 and 9.5 hours post dose of each treatment period. | FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge. The maximal percentage change within 60 minutes following exercise challenge was derived by taking minimum percentage change in FEV1 over 5, 10, 15, 30, 45 and 60 minutes post challenge. Percent change FEV1 = 100\*(FEV1 - Pre-challenge FEV1)/ Pre-challenge FEV1. If the exercise challenge was not completed successfully (i.e. heart rate maintained at \>=80% of the predicted value for 6 minutes), the FEV1 maximal percent change (0-60)was set to be missing. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated. |
| Secondary | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | Baseline (pre dose) and 0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period. | FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge.Weighted mean FEV1 percentage change recorded during 0-60 minutes post challenge was determined for each challenge, by dividing area under curve (AUC) for percent change from Baseline FEV1 measurements at 5, 10, 15, 30, 45 and 60 minutes post challenge by time interval. Actual times were used to determine time interval where available; otherwise planned relative time was used. If one or more FEV1 values were missing, AUC was calculated over time interval of available values. If intermittent values were missing over a participant's profile,it was assumed to be linear between 2 available values for calculation of AUC. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. |
| Secondary | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period | The time from maximal percentage change in FEV1 to recovery to within 5% of pre challenge Baseline (in minutes) was derived using actual sampling times. Time to FEV1 recovery= \[SAS date/time of recovery(a) FEV1 - SAS date/time of FEV1 Maximum % Change0-60\] / 60, where "a" is earliest recorded FEV1 either above pre-challenge Baseline or within 5% below pre challenge Baseline. Any unscheduled FEV1 measurements taken after last scheduled post challenge measurement was considered when deriving this endpoint. A corresponding censoring variable was derived for analysis to indicate whether recovery to within 5% of pre-challenge Baseline was achieved. The censoring variable was set to 1 if recovery to within 5% of Baseline was achieved. If recovery was not evident from data collected, time to recovery was calculated using the date/time of the last available post challenge FEV1 assessment and censoring variable was set to zero. Analysis was performed using a Cox proportional hazards model. |
| Secondary | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 0 to 90 minutes following exercise challenge of each treatment period | Rescue medication was provided to participants at any time and it was strongly recommended for participants with a FEV1 decrease of at least 40% following exercise challenge compared to Baseline. Rescue medication was administered 0 to 90 minutes post exercise challenge. Statistical analysis was supposed to be performed using logistic regression, however, the data was too sparse to permit any formal statistical analysis. |
| Secondary | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of treatment period | All participants rested for at least 10 minutes in the supine position prior to vital signs recordings. Vital signs Baseline values for SBP and DBP for each treatment period were calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge. |
| Secondary | Assessment of Vital Signs: Heart Rate (HR) | Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of each treatment period | All participants rested for at least 10 minutes in the supine position prior to vital signs recordings. Vital signs Baseline values for HR for each treatment period were calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge. |
| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours of each treatment period | All participants rested for at least 10 minutes in the supine position prior to ECG recordings. ECG Baseline values for each treatment period was calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours, 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours. Participants with not clinically significant (NCS) abnormal values were reported. Potential clinical importance range for the ECG parameters are as follows: absolute QTc interval \>450 millisecond (msec), increase from Baseline QTc \>60 msec, PR interval \<110 and \>220 msec and QRS interval \<75 and \>110 msec. No participants reported clinically significant abnormal values. |
| Secondary | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Pre dose and 25 hours and 30 minutes post dose of each treatment period | Blood samples were collected for the assessment of clinical chemistry parameters for albumin and total protein at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose. |
| Secondary | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | Pre dose and 25 hours and 30 minutes post dose of each treatment period | Blood samples were collected for the assessment of clinical chemistry parameters for ALP, ALT, AST and GGT at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose | Baseline (pre dose) and 60 minutes following the exercise challenge at 24 hours post dose of each treatment period. | The 'Efficacy Population' was defined as all participants who received at least one dose of study medication and are not major protocol violators. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | Baseline (pre dose) and 60 minutes following the exercise challenge at 2 and 9.5 hours post dose of each treatment period. | Efficacy Population. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | Baseline (pre dose) and 0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period. | Efficacy Population. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period | Efficacy Population. | Minutes | MEDIAN |
| SECONDARY | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 0 to 90 minutes following exercise challenge of each treatment period | Efficacy Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of treatment period | All Subjects Population was defined as all participants who received at least one dose of study medication. | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Assessment of Vital Signs: Heart Rate (HR) | Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of each treatment period | All Subjects Population. | Beats per minute | MEAN |
| SECONDARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours of each treatment period | All Subjects Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Pre dose and 25 hours and 30 minutes post dose of each treatment period | All Subjects Population. Only those participants with data available at the indicated time points were analyzed. | Gram/liter (G/L) | MEAN |
| SECONDARY | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | Pre dose and 25 hours and 30 minutes post dose of each treatment period | All Subjects Population. Only those participants available at the indicated time points were analyzed. | International units per liter (IU/L) | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group485
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose | Placebo | -7.61 | Standard Error 1.326 | Percent change | |
| Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose | GSK2190915 10 mg | -6.33 | Standard Error 1.314 | Percent change | |
| Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose | GSK2190915 50 mg | -7.09 | Standard Error 1.307 | Percent change | |
| Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose | GSK2190915 100 mg | -7.28 | Standard Error 1.314 | Percent change | |
| Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose | GSK2190915 200 mg | -5.09 | Standard Error 1.315 | Percent change | |
| Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | Placebo | 2 Hours | -15.55 | Standard Error 1.437 | Percent change |
| Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | GSK2190915 10 mg | 2 Hours | -13.04 | Standard Error 1.424 | Percent change |
| Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | GSK2190915 50 mg | 2 Hours | -12.95 | Standard Error 1.416 | Percent change |
| Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | GSK2190915 100 mg | 2 Hours | -12.76 | Standard Error 1.424 | Percent change |
| Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | GSK2190915 200 mg | 2 Hours | -9.25 | Standard Error 1.425 | Percent change |
1 to 10 of 485Source ClinicalTrials.gov
See all 485 results by groupParticipant flow270
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | P/A/D/B/C | 5 | |
| Treatment Period 1 | STARTED | A/B/P/C/D | 4 | |
| Treatment Period 1 | STARTED | B/C/A/D/P | 5 | |
| Treatment Period 1 | STARTED | C/D/B/P/A | 4 | |
| Treatment Period 1 | STARTED | D/P/C/A/B | 5 | |
| Treatment Period 1 | STARTED | C/B/D/A/P | 5 | |
| Treatment Period 1 | STARTED | D/C/P/B/A | 5 | |
| Treatment Period 1 | STARTED | P/D/A/C/B | 5 | |
| Treatment Period 1 | STARTED | A/P/B/D/C | 4 | |
| Treatment Period 1 | STARTED | B/A/C/P/D | 5 |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Placebo | 2 | 44 | |
| other | Dizziness | Nervous system disorders | GSK2190915 10 mg | 1 | 45 | |
| other | Dizziness | Nervous system disorders | GSK2190915 50 mg | 2 | 47 | |
| other | Dizziness | Nervous system disorders | GSK2190915 100 mg | 0 | 45 | |
| other | Dizziness | Nervous system disorders | GSK2190915 200 mg | 0 | 45 | |
| other | Headache | Nervous system disorders | Placebo | 1 | 44 | |
| other | Headache | Nervous system disorders | GSK2190915 10 mg | 0 | 45 | |
| other | Headache | Nervous system disorders | GSK2190915 50 mg | 0 | 47 | |
| other | Headache | Nervous system disorders | GSK2190915 100 mg | 0 | 45 | |
| other | Headache | Nervous system disorders | GSK2190915 200 mg | 2 | 45 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 44 |
| Total, all-cause mortality | GSK2190915 10 mg | 0 | 45 |
| Total, all-cause mortality | GSK2190915 50 mg | 0 | 47 |
| Total, all-cause mortality | GSK2190915 100 mg | 0 | 45 |
| Total, all-cause mortality | GSK2190915 200 mg | 0 | 45 |
| Total, other adverse events | Placebo | 4 | 44 |
| Total, other adverse events | GSK2190915 10 mg | 4 | 45 |
| Total, other adverse events | GSK2190915 50 mg | 4 | 47 |
| Total, other adverse events | GSK2190915 100 mg | 0 | 45 |
| Total, other adverse events | GSK2190915 200 mg | 4 | 45 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24717789 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00812929
GET https://conductscience.org/api/trials/v1/NCT00812929/registered?page=2