Trial · NCT00839800
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study | week 52 | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | percentage of participants | NUMBER |
| SECONDARY | Number of Asthma Exacerbations | up to 52 weeks | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Asthma exacerbations | NUMBER |
| SECONDARY | Morning Peak Expiratory Flow (PEF) | 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Liter/minute (L/min) | MEAN |
| SECONDARY | Evening PEF | 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | L/min | MEAN |
| SECONDARY | Forced Expiratory Volume in One Second (FEV1) | 4, 12, 24, 36 and 52 weeks after randomization | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Liter (L) | GEOMETRIC_MEAN |
| SECONDARY | Use of As-needed Medication | 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | inhalations/day | MEAN |
| SECONDARY | Asthma Symptom Score | 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | units on a scale | MEAN |
| SECONDARY | Nights With Awakening(s) Due to Asthma Symptoms | 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Nights With Awakening(s) | MEAN |
| SECONDARY | The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations | up to 52 weeks | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | percentage of participants | NUMBER |
| SECONDARY | Symptom-free Days (no Symptoms and no Awakenings) | 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | symptom-free days | MEAN |
| SECONDARY | Percentage of As-needed-free Days | 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | percentage of as-needed-free days | MEAN |
| SECONDARY | Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use) | 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | percentage of asthma-control days | MEAN |
| SECONDARY | Asthma Control Questionnaire (ACQ) | 4, 12, 24, 36 and 52 weeks after randomization | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | units on a scale | MEAN |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00839800/outcomes