Phase 3
Completed N=3,991
Tiotropium / Respimat One Year Study in COPD.
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00387088 ↗
Enrolled (actual)
3,991
Serious AEs
17.3%
Results posted
Jan 2010
Primary outcomePrimary: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 — 0.119; 0.018 Litres — p=<0.0001
Summary
The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 |
0.119; 0.018 | <0.0001 sig |
| PRIMARY Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
NA; NA | — |
| SECONDARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 |
0.11; 0.017 | — |
| SECONDARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169 |
0.121; 0.018 | — |
| SECONDARY Number of COPD Exacerbations Per Patient - Exposure Adjusted |
0; 0 | — |
| SECONDARY Number of COPD Exacerbations Per Patient - naïve Estimate |
0; 0 | — |
| SECONDARY Number of Patients With at Least One COPD Exacerbation |
685; 842 | — |
| SECONDARY Time to First Hospitalisation for COPD Exacerbation |
NA; NA | — |
| SECONDARY Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted |
0; 0 | — |
| SECONDARY Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate |
0; 0 | — |
| SECONDARY Number of Patients With at Least One Hospitalisation for a COPD Exacerbation |
161; 198 | — |
| SECONDARY Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337 |
-4.726; -1.787 | — |
| SECONDARY Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169 |
-4.764; -2.568 | — |
| SECONDARY Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337 |
-7.260; -3.307; -3.196; -0.226; -4.873; -2.038 | — |
| SECONDARY Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169 |
-6.555; -3.268; -3.573; -1.218; -4.917; -2.935 | — |
| SECONDARY Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29 |
0.176; 0.025 | — |
| SECONDARY Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169 |
0.179; 0.019 | — |
| SECONDARY Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337 |
0.168; -0.001 | — |
| SECONDARY Marked Changes From Baseline in Vital Signs at End of Treatment |
29; 31; 6; 12; 40; 39 | — |
| SECONDARY Clinically Relevant Findings in Physical Examination and ECG |
1723; 1733; 22; 17; 207; 215 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female
- At least 40 years old
- Smoker or ex-smoker
- Smoking history > 10 pack-years
- Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted
Exclusion Criteria
- Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
- History of asthma or allergic conditions.
- Malignancy requiring treatment within past 5 years
- Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
- Known active tuberculosis
- Known hypersensitivity to anticholinergic drugs.
Data sourced from ClinicalTrials.gov (NCT00387088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.