Trial · NCT00387088
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 | Baseline and Day 337 | Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration). |
| Primary | Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation. |
| Secondary | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 | Baseline and Day 29 | Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug. |
| Secondary | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169 | Baseline and Day 169 | Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug. |
| Secondary | Number of COPD Exacerbations Per Patient - Exposure Adjusted | During actual study treatment period (planned Day 1 to Day 337) | Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure) |
| Secondary | Number of COPD Exacerbations Per Patient - naïve Estimate | During actual study treatment period (planned Day 1 to Day 337) | Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate) |
| Secondary | Number of Patients With at Least One COPD Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) |
| Secondary | Time to First Hospitalisation for COPD Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation |
| Secondary | Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted | During actual study treatment period (planned Day 1 to Day 337) | Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure) |
| Secondary | Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate | During actual study treatment period (planned Day 1 to Day 337) | Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate) |
| Secondary | Number of Patients With at Least One Hospitalisation for a COPD Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) |
| Secondary | Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337 | Baseline and Day 337 | The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state |
| Secondary | Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169 | Baseline and Day 169 | The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state |
| Secondary | Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337 | Baseline and Day 337 | The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state |
| Secondary | Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169 | Baseline and Day 169 | The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state |
| Secondary | Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29 | Baseline and Day 29 | Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug. |
| Secondary | Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169 | Baseline and Day 169 | Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug. |
| Secondary | Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337 | Baseline and Day 337 | Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug. |
| Secondary | Marked Changes From Baseline in Vital Signs at End of Treatment | Baseline and end of treatment | Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment. SBP - Increase means SBP \>150 mmHg and an increase above baseline of \>25 mmHg. SBP - Decrease means SBP \<100 mmHg and a decrease below baseline of \>10 mmHg. DBP - Increase means DBP \>90 mmHg and an increase above baseline of \>10 mmHg. DBP - Decrease means DBP \<60 mmHg and a decrease below baseline of \>10 mmHg. PR - Increase means PR \>100 bpm and an increase above baseline of \>10 bpm. PR - Decrease means PR \<60 bpm and a decrease below baseline of \>10 bpm. |
| Secondary | Clinically Relevant Findings in Physical Examination and ECG | End of treatment | Clinically relevant findings in Physical Examination and ECG at end of treatment |
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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