Trial · NCT00839800
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study | week 52 | Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid \[GCS\] treatment, hospitalization, or emergency room \[ER\] treatment. |
| Secondary | Number of Asthma Exacerbations | up to 52 weeks | Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here. |
| Secondary | Morning Peak Expiratory Flow (PEF) | 52-week treatment period | The mean value from a 52-week treatment period. |
| Secondary | Evening PEF | 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period | The mean value from a 52-week treatment period. |
| Secondary | Forced Expiratory Volume in One Second (FEV1) | 4, 12, 24, 36 and 52 weeks after randomization | The mean value for Weeks 4, 12, 24, 36 and 52 was analysed. |
| Secondary | Use of As-needed Medication | 52-week treatment period | The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time). |
| Secondary | Asthma Symptom Score | 52-week treatment period | The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst). |
| Secondary | Nights With Awakening(s) Due to Asthma Symptoms | 52-week treatment period | The mean value from the treatment period was presented here. |
| Secondary | The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations | up to 52 weeks | Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here. |
| Secondary | Symptom-free Days (no Symptoms and no Awakenings) | 52-week treatment period | A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here. |
| Secondary | Percentage of As-needed-free Days | 52-week treatment period | An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here. |
| Secondary | Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use) | 52-week treatment period | An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here. |
| Secondary | Asthma Control Questionnaire (ACQ) | 4, 12, 24, 36 and 52 weeks after randomization | The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here. |
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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