Trial · NCT01069289
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pre-dose Forced Expiratory Volume in One Second (FEV1) | Before randomization, 0, 4, 8 and 12 weeks after randomization | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group |
| Secondary | 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1) | Before randomization, 0, 4, 8 and 12 weeks after randomization | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group |
| Secondary | Pre-dose Forced Vital Capacity (FVC) | Before randomization, 0, 4, 8 and 12 weeks after randomization | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group |
| Secondary | 1 Hour Post-dose Forced Vital Capacity (FVC) | Before randomization, 0, 4, 8 and 12 weeks after randomization | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group |
| Secondary | Percentage of Participants With Exacerbations | Daily during 12-week randomization treatment | A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group. |
| Secondary | Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Daily during 12-week randomization treatment | A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 12-week randomization treatment |
| Secondary | Morning Peak Expiratory Flow(PEF) | Daily during run-in period and daily during 12-week randomization treatment | The change from Run-in period average to Treatment period average for each treatment group |
| Secondary | Evening Peak Expiratory Flow (PEF) | Daily during run-in period and daily during 12-week randomization treatment | The change from Run-in period average to Treatment period average for each treatment group |
| Secondary | Total Number of Day With Exacerbation | Daily during 12-week randomization treatment | Total number of days with COPD exacerbation for each treatment group |
| Secondary | Morning Forced Expiratory Volume in One Second (FEV1) | Daily during run-in period and daily during 12-week randomization treatment | The change from Run-in period average to Treatment period average for each treatment group |
| Secondary | Evening Forced Expiratory Volume in One Second (FEV1) | Daily during run-in period and daily during 12-week randomization treatment | The change from Run-in period average to Treatment period average for each treatment group |
| Secondary | Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | Daily during run-in period and daily during 12-week randomization treatment | Scored 0 to 1 (0 = no awakening and 1 = awakening). The change from Run-in period average to Treatment period average for each treatment group |
| Secondary | Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | Daily during run-in period and daily during 12-week randomization treatment | There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group |
| Secondary | Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | Daily during run-in period and daily during 12-week randomization treatment | There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group |
| Secondary | Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score | Daily during run-in period and daily during 12-week randomization treatment | The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group. |
| Secondary | Use of Rescue Medication | Daily during run-in period and daily during 12-week randomization treatment | The change from Run-in period average to Treatment period average for each treatment group. |
| Secondary | St George's Respiratory Questionnaire (SGRQ) Total Score | Daily during run-in period and daily during 12-week randomization treatment | The change from Run-in period average to Treatment period average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life). |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01069289/registered