Phase 3
Completed N=5,992
Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00144339 ↗
Enrolled (actual)
5,992
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years — -30; -30 ml/year — p=0.9524
Summary
The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years |
-30; -30 | 0.9524 |
| PRIMARY Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years |
-42; -40 | 0.2074 |
| SECONDARY Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment |
-17; -15 | 0.2488 |
| SECONDARY Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment |
-32; -27 | 0.0145 sig |
| SECONDARY Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years |
-39; -43 | 0.2990 |
| SECONDARY Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years |
-61; -61 | 0.8375 |
| SECONDARY Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years |
-41; -47 | 0.1143 |
| SECONDARY Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years |
-65; -66 | 0.7870 |
| SECONDARY Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score |
1.21; 1.25 | 0.7840 |
| SECONDARY Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment |
-12; -10 | 0.2705 |
| SECONDARY Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment |
-40; -40 | 0.306 |
| SECONDARY Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment |
-17; -17 | 0.8103 |
| SECONDARY Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment |
-46; -42 | 0.9814 |
| SECONDARY Time to First Exacerbation |
12.51; 16.65 | <0.0001 sig |
| SECONDARY Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year |
0.85; 0.73 | <0.0001 sig |
| SECONDARY Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
2049; 2001; 68.2; 67 | 0.3481 |
| SECONDARY Number of Exacerbation Days Per Patient Year |
13.64; 12.11 | 0.0011 sig |
| SECONDARY Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients) |
28.64; 35.89 | 0.1766 |
| SECONDARY Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization |
811; 759; 27; 25.4 | 0.0024 sig |
| SECONDARY Number of Exacerbation Leading to Hospitalization |
0.16; 0.15 | 0.3413 |
| SECONDARY Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization |
3.13; 3.17 | 0.8624 |
| SECONDARY Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 |
1.134; 1.221 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1 |
1.372; 1.418 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 |
1.126; 1.225 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6 |
1.365; 1.423 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 |
1.111; 1.213 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12 |
1.345; 1.398 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 |
1.101; 1.192 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18 |
1.326; 1.379 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 |
1.079; 1.173 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24 |
1.294; 1.356 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 |
1.061; 1.156 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30 |
1.274; 1.335 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 |
1.045; 1.144 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36 |
1.250; 1.315 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 |
1.034; 1.129 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42 |
1.236; 1.297 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 |
1.024; 1.112 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48 |
1.219; 1.268 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1 |
2.667; 2.856 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1 |
3.149; 3.204 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6 |
2.658; 2.862 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6 |
3.137; 3.193 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12 |
2.640; 2.838 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12 |
3.110; 3.158 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18 |
2.622; 2.816 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18 |
3.075; 3.126 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24 |
2.597; 2.785 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24 |
3.036; 3.095 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30 |
2.572; 2.757 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 |
3.010; 3.057 | 0.0005 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36 |
2.553; 2.753 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36 |
2.973; 3.038 | <.0001 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42 |
2.540; 2.724 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42 |
2.959; 3.005 | 0.0020 sig |
| SECONDARY Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48 |
2.532; 2.702 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48 |
2.929; 2.961 | 0.0365 sig |
| SECONDARY Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1 |
2.847; 3.017 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1 |
3.280; 3.318 | 0.0002 sig |
| SECONDARY Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6 |
2.841; 3.027 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6 |
3.268; 3.304 | 0.0018 sig |
| SECONDARY Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12 |
2.820; 2.996 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12 |
3.228; 3.260 | 0.0069 sig |
| SECONDARY Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18 |
2.811; 2.965 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18 |
3.195; 3.234 | 0.0020 sig |
| SECONDARY Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24 |
2.775; 2.942 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24 |
3.157; 3.189 | 0.0165 sig |
| SECONDARY Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30 |
2.738; 2.908 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30 |
3.126; 3.157 | 0.0248 sig |
| SECONDARY Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36 |
2.731; 2.897 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36 |
3.086; 3.136 | 0.0004 sig |
| SECONDARY Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42 |
2.713; 2.875 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42 |
3.073; 3.100 | 0.0809 |
| SECONDARY Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48 |
2.696; 2.846 | <.0001 sig |
| SECONDARY Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48 |
3.041; 3.067 | 0.0915 |
| SECONDARY Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6 |
42.289; 39.409 | <.0001 sig |
| SECONDARY Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12 |
42.501; 39.730 | <.0001 sig |
| SECONDARY Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18 |
43.067; 40.474 | <.0001 sig |
| SECONDARY Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24 |
43.562; 41.178 | <.0001 sig |
| SECONDARY Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30 |
44.342; 41.919 | <.0001 sig |
| SECONDARY Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36 |
45.280; 41.935 | <.0001 sig |
| SECONDARY Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42 |
45.722; 42.905 | <.0001 sig |
| SECONDARY Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48 |
45.968; 43.665 | <.0001 sig |
| SECONDARY Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment) |
402; 374; 13.4; 12.5 | 0.0242 sig |
| SECONDARY Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days) |
495; 446; 16.5; 14.9 | 0.0859 |
| SECONDARY Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause) |
140; 131; 4.7; 4.4 | 0.1936 |
| SECONDARY Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days) |
173; 153; 5.8; 5.1 | 0.2377 |
Eligibility Criteria
Inclusion Criteria
- Written informed consent.
- Male or female patients 40 years of age or older.
- Smoking history of at least 10 pack years.
- Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1 12 hr/day.
- Use of oral corticosteroids at unstable doses or >10 mg/day.
Data sourced from ClinicalTrials.gov (NCT00144339). 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.