Trial · NCT00387088
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 | Baseline and Day 337 | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data. | Litres | LEAST_SQUARES_MEAN |
| PRIMARY | Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | Days | MEDIAN |
| SECONDARY | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 | Baseline and Day 29 | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FEV1 data. | Litres | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169 | Baseline and Day 169 | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data. | Litres | LEAST_SQUARES_MEAN |
| SECONDARY | Number of COPD Exacerbations Per Patient - Exposure Adjusted | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | COPD exacerbations per year | MEDIAN |
| SECONDARY | Number of COPD Exacerbations Per Patient - naïve Estimate | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | COPD exacerbations | MEDIAN |
| SECONDARY | Number of Patients With at Least One COPD Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | participants | NUMBER |
| SECONDARY | Time to First Hospitalisation for COPD Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | Days | MEDIAN |
| SECONDARY | Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | hospitalisations for COPD exacerbations | MEDIAN |
| SECONDARY | Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | hospitalisations for COPD exacerbations | MEDIAN |
| SECONDARY | Number of Patients With at Least One Hospitalisation for a COPD Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | participants | NUMBER |
| SECONDARY | Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337 | Baseline and Day 337 | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169 | Baseline and Day 169 | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337 | Baseline and Day 337 | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169 | Baseline and Day 169 | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29 | Baseline and Day 29 | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FVC data. | Litres | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169 | Baseline and Day 169 | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data. | Litres | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337 | Baseline and Day 337 | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data. | Litres | LEAST_SQUARES_MEAN |
| SECONDARY | Marked Changes From Baseline in Vital Signs at End of Treatment | Baseline and end of treatment | Treated set | participants | NUMBER |
| SECONDARY | Clinically Relevant Findings in Physical Examination and ECG | End of treatment | Treated set | participants | NUMBER |
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/NCT00387088/outcomes