Phase 4
Completed N=349
A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00359788 ↗
Enrolled (actual)
349
Serious AEs
6.6%
Results posted
Nov 2009
Primary outcomePrimary: Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks — 0.081; -0.025 Liters — p=<0.0001
Summary
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks |
0.081; -0.025 | <0.0001 sig |
| PRIMARY Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks |
0.187; 0.167 | 0.0042 sig |
| SECONDARY Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks |
0.11; -0.036 | <0.0001 sig |
| SECONDARY Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1 |
0.132; 0.211 | <0.0001 sig |
| SECONDARY Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6 |
0.207; 0.153 | 0.0447 sig |
| SECONDARY Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1 |
0.232; 0.364 | <0.0001 sig |
| SECONDARY Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6 |
0.204; 0.356 | <0.0001 sig |
| SECONDARY Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12 |
0.209; 0.342 | <0.0001 sig |
| SECONDARY Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks |
0.225; 0.051 | 0.0015 sig |
| SECONDARY Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks |
0.443; 0.432 | 0.835 |
| SECONDARY Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks |
0.258; -0.02 | <0.0001 sig |
| SECONDARY Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1 |
0.327; 0.484 | <0.0001 sig |
| SECONDARY Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks |
0.464; 0.425 | 0.4386 |
| SECONDARY Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1 |
0.542; 0.824 | 0.0001 sig |
| SECONDARY Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6 |
0.43; 0.791 | <0.0001 sig |
| SECONDARY Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12 |
0.418; 0.703 | <0.0001 sig |
| SECONDARY FEV1 at 15 Minutes on Day 1 |
1.214; 1.389 | <0.0001 sig |
| SECONDARY FEV1 at 30 Minutes on Day 1 |
1.261; 1.429 | <0.0001 sig |
| SECONDARY FEV1 at 1 Hour on Day 1 |
1.272; 1.455 | <0.0001 sig |
| SECONDARY FEV1 at 2 Hours on Day 1 |
1.293; 1.43 | <0.0001 sig |
| SECONDARY FEV1 at 3 Hours on Day 1 |
1.29; 1.375 | <0.0001 sig |
| SECONDARY FEV1 at 4 Hours on Day 1 |
1.284; 1.319 | 0.0997 |
| SECONDARY FEV1 at 6 Hours on Day 1 |
1.269; 1.233 | 0.101 |
| SECONDARY FEV1 at -10 Minutes at Week 6 |
1.254; 1.108 | <0.0001 sig |
| SECONDARY FEV1 at 15 Minutes at Week 6 |
1.3; 1.355 | 0.0411 sig |
| SECONDARY FEV1 at 30 Minutes at Week 6 |
1.328; 1.388 | 0.0354 sig |
| SECONDARY FEV1 at 1 Hour at Week 6 |
1.343; 1.405 | 0.041 sig |
| SECONDARY FEV1 at 2 Hours at Week 6 |
1.364; 1.382 | 0.5387 |
| SECONDARY FEV1 at 3 Hours at Week 6 |
1.371; 1.31 | 0.0372 sig |
| SECONDARY FEV1 at 4 Hours at Week 6 |
1.369; 1.247 | <0.0001 sig |
| SECONDARY FEV1 at 6 Hours at Week 6 |
1.33; 1.168 | <0.0001 sig |
| SECONDARY FEV1 at -10 Minutes at Week 12 |
1.225; 1.119 | <0.0001 sig |
| SECONDARY FEV1 at 15 Minutes at Week 12 |
1.268; 1.351 | 0.0023 sig |
| SECONDARY FEV1 at 30 Minutes at Week 12 |
1.306; 1.393 | 0.0019 sig |
| SECONDARY FEV1 at 1 Hour at Week 12 |
1.327; 1.41 | 0.0044 sig |
| SECONDARY FEV1 at 2 Hours at Week 12 |
1.353; 1.398 | 0.1182 |
| SECONDARY FEV1 at 3 Hours at Week 12 |
1.353; 1.333 | 0.4814 |
| SECONDARY FEV1 at 4 Hours at Week 12 |
1.337; 1.263 | 0.008 sig |
| SECONDARY FEV1 at 6 Hours at Week 12 |
1.318; 1.182 | <0.0001 sig |
| SECONDARY FVC at 15 Minutes on Day 1 |
2.938; 3.308 | <0.0001 sig |
| SECONDARY FVC at 30 Minutes on Day 1 |
3.044; 3.4 | <0.0001 sig |
| SECONDARY FVC at 1 Hour on Day 1 |
3.087; 3.444 | <0.0001 sig |
| SECONDARY FVC at 2 Hours on Day 1 |
3.103; 3.388 | <0.0001 sig |
| SECONDARY FVC at 3 Hours on Day 1 |
3.091; 3.261 | 0.0003 sig |
| SECONDARY FVC at 4 Hours on Day 1 |
3.087; 3.136 | 0.2992 |
| SECONDARY FVC at 6 Hours on Day 1 |
3.053; 2.972 | 0.0984 |
| SECONDARY FVC at -10 Minutes at Week 6 |
3; 2.722 | <0.0001 sig |
| SECONDARY FVC at 15 Minutes at Week 6 |
3.09; 3.279 | 0.0004 sig |
| SECONDARY FVC at 30 Minutes at Week 6 |
3.158; 3.362 | 0.0003 sig |
| SECONDARY FVC at 1 Hour at Week 6 |
3.206; 3.388 | 0.012 sig |
| SECONDARY FVC at 2 Hours at Week 6 |
3.227; 3.338 | 0.044 sig |
| SECONDARY FVC at 3 Hours at Week 6 |
3.235; 3.185 | 0.3634 |
| SECONDARY FVC at 4 Hours at Week 6 |
3.23; 3.068 | 0.0032 sig |
| SECONDARY FVC at 6 Hours at Week 6 |
3.190; 2.914 | <0.0001 sig |
| SECONDARY FVC at -10 Minutes at Week 12 |
2.967; 2.792 | 0.0015 sig |
| SECONDARY FVC at 15 Minutes at Week 12 |
3.069; 3.263 | 0.0002 sig |
| SECONDARY FVC at 30 Minutes at Week 12 |
3.143; 3.358 | <0.0001 sig |
| SECONDARY FVC at 1 Hour at Week 12 |
3.177; 3.375 | 0.0006 sig |
| SECONDARY FVC at 2 Hours at Week 12 |
3.231; 3.328 | 0.0896 |
| SECONDARY FVC at 3 Hours at Week 12 |
3.226; 3.218 | 0.8937 |
| SECONDARY FVC at 4 Hours at Week 12 |
3.199; 3.074 | 0.0269 sig |
| SECONDARY FVC at 6 Hours at Week 12 |
3.155; 2.932 | 0.0001 sig |
| SECONDARY Day Time Albuterol Use During Week 1 |
1.175; 1.217 | 0.7196 |
| SECONDARY Day Time Albuterol Use During Week 2 |
1.24; 1.309 | 0.6189 |
| SECONDARY Day Time Albuterol Use During Week 3 |
1.337; 1.41 | 0.6197 |
| SECONDARY Day Time Albuterol Use During Week 4 |
1.287; 1.399 | 0.4582 |
| SECONDARY Day Time Albuterol Use During Week 5 |
1.275; 1.345 | 0.6538 |
| SECONDARY Day Time Albuterol Use During Week 6 |
1.259; 1.405 | 0.4145 |
| SECONDARY Day Time Albuterol Use During Week 7 |
1.313; 1.398 | 0.6048 |
| SECONDARY Day Time Albuterol Use During Week 8 |
1.301; 1.471 | 0.3137 |
| SECONDARY Day Time Albuterol Use During Week 9 |
1.369; 1.43 | 0.7195 |
| SECONDARY Day Time Albuterol Use During Week 10 |
1.351; 1.394 | 0.7947 |
| SECONDARY Day Time Albuterol Use During Week 11 |
1.352; 1.445 | 0.6049 |
| SECONDARY Day Time Albuterol Use During Week 12 |
1.361; 1.409 | 0.8109 |
| SECONDARY Night Time Albuterol Use During Week 1 |
3.493; 2.966 | 0.1471 |
| SECONDARY Night Time Albuterol Use During Week 2 |
3.269; 3.004 | 0.3192 |
| SECONDARY Night Time Albuterol Use During Week 3 |
3.282; 2.931 | 0.182 |
| SECONDARY Night Time Albuterol Use During Week 4 |
3.285; 2.921 | 0.1777 |
| SECONDARY Night Time Albuterol Use During Week 5 |
3.152; 2.789 | 0.1805 |
| SECONDARY Night Time Albuterol Use During Week 6 |
3.178; 2.806 | 0.1777 |
| SECONDARY Night Time Albuterol Use During Week 7 |
3.156; 2.966 | 0.5725 |
| SECONDARY Night Time Albuterol Use During Week 8 |
3.104; 2.983 | 0.6765 |
| SECONDARY Night Time Albuterol Use During Week 9 |
3.254; 3.006 | 0.3943 |
| SECONDARY Night Time Albuterol Use During Week 10 |
3.199; 2.909 | 0.3091 |
| SECONDARY Night Time Albuterol Use During Week 11 |
3.224; 2.907 | 0.2911 |
| SECONDARY Night Time Albuterol Use During Week 12 |
3.178; 3.069 | 0.7458 |
| SECONDARY Morning Peak Expiratory Flow Rate (PEFR) at Week 1 |
205.8; 195.1 | 0.0004 sig |
| SECONDARY Morning PEFR at Week 2 |
206.07; 194.81 | 0.0023 sig |
| SECONDARY Morning PEFR at Week 3 |
206.61; 193.83 | 0.0015 sig |
| SECONDARY Morning PEFR at Week 4 |
206.76; 193.19 | 0.0013 sig |
| SECONDARY Morning PEFR at Week 5 |
205.6; 193.55 | 0.005 sig |
| SECONDARY Morning PEFR at Week 6 |
206.49; 195.38 | 0.0159 sig |
| SECONDARY Morning PEFR at Week 7 |
208.72; 197.66 | 0.0219 sig |
| SECONDARY Morning PEFR at Week 8 |
208.88; 195.22 | 0.0048 sig |
| SECONDARY Morning PEFR at Week 9 |
208.97; 194.74 | 0.0058 sig |
| SECONDARY Morning PEFR at Week 10 |
204.83; 193.23 | 0.0248 sig |
| SECONDARY Morning PEFR at Week 11 |
206.47; 195.47 | 0.0325 sig |
| SECONDARY Morning PEFR at Week 12 |
206.52; 192.44 | 0.0153 sig |
| SECONDARY Evening PEFR at Week 1 |
222.89; 222.64 | 0.6105 |
| SECONDARY Evening PEFR at Week 2 |
221.97; 221.12 | 0.8249 |
| SECONDARY Evening PEFR at Week 3 |
221.23; 218.52 | 0.4896 |
| SECONDARY Evening PEFR at Week 4 |
221.96; 215.06 | 0.0935 |
| SECONDARY Evening PEFR at Week 5 |
217.95; 214.53 | 0.4339 |
| SECONDARY Evening PEFR at Week 6 |
218.45; 219.42 | 0.845 |
| SECONDARY Evening PEFR at Week 7 |
220.98; 220.79 | 0.9696 |
| SECONDARY Evening PEFR at Week 8 |
223.33; 218.2 | 0.3252 |
| SECONDARY Evening PEFR at Week 9 |
221.47; 217.41 | 0.452 |
| SECONDARY Evening PEFR at Week 10 |
220.46; 216.32 | 0.4388 |
| SECONDARY Evening PEFR at Week 11 |
218.35; 217.17 | 0.8288 |
| SECONDARY Evening PEFR at Week 12 |
219.66; 215.46 | 0.4929 |
| SECONDARY Patient Global Evaluation |
4.49; 4.239 | 0.0765 |
| SECONDARY Patient Global Evaluation |
4.49; 4.239 | 0.0765 |
| SECONDARY Physician Global Evaluation |
5.057; 4.772 | 0.0085 sig |
| SECONDARY Physician Global Evaluation |
5.057; 4.772 | 0.0085 sig |
Eligibility Criteria
Inclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Age: greater than or equal to 40 years
- Current or ex-smoker with a >= 10 pack-year smoking history
- Use of Combivent® Metered Dose Inhaler (MDI)for >= 1 month prior to Visit 1
Spirometric criteria (determined at study visits):
- Post-bronchodilator Forced Expiratory Volume in one second (FEV1) 1 hour per day or if unable to abstain fr om using oxygen during Pulmonary Function Tests
- Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
- Recent history 6 months or less of Myocardial Infarction
- Unstable or life-threatening cardiac arrhythmias
- Hospitalization for Congestive Heart Failure during past year
- Malignancy for which patient is receiving chemo or radiation therapy
- Pregnant or nursing women
- Known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose
- Use of SPIRIVA® 3 months prior to Visit 1
- Symptomatic of prostatic hypertrophy or bladder neck obstruction
- Known narrow- angle glaucoma
- Participating in a pulmonary rehab program within 4 weeks of Visit 1
Data sourced from ClinicalTrials.gov (NCT00359788). 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.