Trial · NCT00812929
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| 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 |
| SECONDARY | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | 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. | Micromoles per liter (µmol/L) | MEAN |
| SECONDARY | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | 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. | Millimole per liter (mmol/L) | MEAN |
| SECONDARY | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | 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. | Cells x 10^9 per liter | MEAN |
| SECONDARY | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | 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. | G/L | MEAN |
| SECONDARY | Assessment of Hematology Parameters: Hematocrit | 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. | Ratio | MEAN |
| SECONDARY | Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH) | 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 | Picograms | MEAN |
| SECONDARY | Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV) | 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. | Femtoliter | MEAN |
| SECONDARY | Assessment of Hematology Parameters: Red Blood Cell Count (RBC) | 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. | Cells x 10^12 per liter | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to follow up (7 to 21 days) following last dose | All Subjects Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | Baseline (pre dose) up to 24 Hours post dose of each treatment period | Pharmacodynamics (PD) Population was defined as participants in the 'All Subjects' Population for whom a PD sample (blood or urine) was obtained and analyzed. Only those participants available at the indicated time points were analyzed. | Percent change | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT00812929/outcomes