Phase 4
N=519
Tiotropium In Exercise
Pulmonary Disease, Chronic Obstructive · Exercise
Bottom Line
View on ClinicalTrials.gov: NCT00525512 ↗Enrolled (actual)
519
Serious AEs
14.9%
Results posted
Sep 2011
Primary outcome: Primary: 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase — 297.1; 336.6 seconds — p=0.1062
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- tiotropium 18 mcg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase |
297.1; 336.6 | 0.1062 |
| SECONDARY 90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase |
304.9; 343.0 | 0.008 sig |
| SECONDARY 90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase |
308.6; 338.6 | 0.0597 |
| SECONDARY 90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase |
311.8; 358.7 | 0.0131 sig |
| SECONDARY 90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase |
309.8; 365.7 | 0.0041 sig |
| SECONDARY 90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase |
313.4; 349.0 | 0.0945 |
| SECONDARY 90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase |
302.8; 340.1 | 0.0899 |
| SECONDARY Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase |
1.082; 1.198 | <0.0001 sig |
| SECONDARY Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase |
1.082; 1.164 | 0.0005 sig |
| SECONDARY Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase |
1.090; 1.179 | 0.0003 sig |
| SECONDARY Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase |
1.066; 1.172 | <0.0001 sig |
| SECONDARY Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase |
1.066; 1.157 | 0.0005 sig |
| SECONDARY Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase |
1.039; 1.134 | 0.0002 sig |
| SECONDARY Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase |
1.050; 1.125 | 0.0059 sig |
| SECONDARY Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase |
1.126; 1.280 | <0.0001 sig |
| SECONDARY Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase |
1.092; 1.254 | <0.0001 sig |
| SECONDARY Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase |
1.113; 1.259 | <0.0001 sig |
| SECONDARY Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase |
1.105; 1.232 | <0.0001 sig |
| SECONDARY Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase |
1.097; 1.230 | <0.0001 sig |
| SECONDARY Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase |
1.079; 1.228 | <0.0001 sig |
| SECONDARY Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase |
1.072; 1.202 | <0.0001 sig |
| SECONDARY Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase |
2.432; 2.649 | <0.0001 sig |
| SECONDARY Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase |
2.407; 2.564 | 0.0019 sig |
| SECONDARY Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase |
2.425; 2.607 | 0.0006 sig |
| SECONDARY Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase |
2.406; 2.640 | <0.0001 sig |
| SECONDARY Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase |
2.423; 2.584 | 0.009 sig |
| SECONDARY Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase |
2.343; 2.555 | 0.0002 sig |
| SECONDARY Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase |
2.368; 2.609 | <0.0001 sig |
| SECONDARY Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase |
2.529; 2.806 | <0.0001 sig |
| SECONDARY Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase |
2.442; 2.767 | <0.0001 sig |
| SECONDARY Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase |
2.462; 2.816 | <0.0001 sig |
| SECONDARY Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase |
2.499; 2.758 | <0.0001 sig |
| SECONDARY Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase |
2.466; 2.767 | <0.0001 sig |
| SECONDARY Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase |
2.479; 2.733 | <0.0001 sig |
| SECONDARY Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase |
2.420; 2.753 | <0.0001 sig |
| SECONDARY Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase |
4.1; 3.8 | 0.1131 |
| SECONDARY Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase |
5.6; 5.6 | 0.9071 |
| SECONDARY Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase |
4.0; 4.1 | 0.6878 |
| SECONDARY Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase |
-0.04; 0.32 | — |
| SECONDARY Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase |
0.02; 0.35 | — |
| SECONDARY Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase |
-0.04; 0.30 | — |
| SECONDARY Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase |
0.03; 0.25 | — |
| SECONDARY Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase |
0.03; 0.25 | — |
| SECONDARY Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase |
-0.06; 0.10 | — |
| SECONDARY Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase |
-0.07; 0.10 | — |
| SECONDARY Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase |
-0.03; 0.34 | — |
| SECONDARY Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase |
0.07; 0.30 | — |
| SECONDARY Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase |
0.13; 0.20 | — |
| SECONDARY Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase |
0.02; 0.18 | — |
| SECONDARY Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase |
-0.02; 0.16 | — |
| SECONDARY Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase |
-0.08; 0.09 | — |
| SECONDARY Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase |
-0.04; 0.03 | — |
| SECONDARY Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase |
44.5; 40.5 | 0.0072 sig |
| SECONDARY Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase |
56.9; 54.6 | 0.2029 |
| SECONDARY Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase |
34.0; 30.4 | 0.0313 sig |
| SECONDARY Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase |
54.4; 45.5 | 0.0001 sig |
| SECONDARY Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase |
102; 112; 157; 148 | 0.6541 |
| SECONDARY 90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase |
337.25; 358.80 | 0.4443 |
| SECONDARY Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase |
1.23; 1.23 | 0.8644 |
| SECONDARY Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase |
2.72; 2.77 | 0.4277 |
| SECONDARY Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase |
39.82; 39.21 | 0.7071 |
| SECONDARY Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase |
53.57; 54.46 | 0.6556 |
| SECONDARY Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase |
29.65; 29.67 | 0.9896 |
| SECONDARY Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase |
45.47; 41.14 | 0.0807 |
| SECONDARY Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status |
0; 2; 0; 0; 1; 1 | — |
Summary
The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.
Eligibility Criteria
Inclusion criteria
- All patients must sign an informed consent
- Diagnosis of COPD with specific spirometric criteria (determined at study visits)
- Age >= 40 years
- Medical Research Council Dyspnoea score >= 2
- Current or ex-smoker with a >= 10 pack-year smoking history
- Ability to exercise on treadmill
Exclusion criteria
- Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
- Clinical history of asthma
- Use of supplemental oxygen therapy
- Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
- Recent history ( 35 kg/m2 list truncated for space
Data sourced from ClinicalTrials.gov (NCT00525512). 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.