Trial · NCT01147744
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | Baseline and Week 8 | ITT population. When possible, data from participants who withdrew prematurely from the study were included in the analyses. Any evaluable subject whose FEV1 measurement at Week 8 was missing was included in the analysis by imputation, using the preceding non-missing FEV1 value (last observation carried forward \[LOCF\]). | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Only those participants with analyzable data at the indicated time point were assessed. | Liters per minute | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Only those participants with analyzable data at the indicated time point were assessed. | Liters per minute | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Percentage of symptom-free days | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Percentage of symptom-free nights | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Percentage of rescue-free days | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Percentage of rescue-free nights | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Day-time symptom scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Night-time symptom scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period | Baseline up to Week | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Day-time number of inhalations | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Night-time number of inhalations | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period | Upto 8 Weeks | ITT Population. Only those participants with analyzable data at the indicated time point were assessed. | Participants | COUNT_OF_PARTICIPANTS |
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/NCT01147744/outcomes