Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.

Completed · Phase 4

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2 actuations qid in COPD patients currently prescribed Combivent® MDI.

Key facts

Study ID

NCT00388882

Run by

Boehringer Ingelheim

People needed

327

Starts

2006-10-04

Last updated by the study team

2023-12-01

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of COPD
• Age: >= 40 years
• Current or ex-smoker with a >= 10 pack-year smoking history
• Use of Combivent® MDI for >= 1 month prior to Visit 1 Spirometric criteria (determined at study visits):
• Post-bronchodilator FEV1 <= 70% (Visit 1)
• Pre-bronchodilator FEV1 <= 65% of predicted and FEV1/FVC <= 70% (Visit 2)

You may not qualify if…

• Clinical history of asthma
• History of thoracotomy with pulmonary resection
• History of CF, alpha 1 antitrypsin deficiency or interstitial lung disease
• Daytime use of oxygen therapy for > 1 hour per day or if unable to abstain from using oxygen during PFTs
• Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
• Recent history 6 months or less of MI
• Unstable or life-threatening cardiac arrhythmias
• Hospitalization for CHF 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

Where it is running

• 205.346.107 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 205.346.104 Boehringer Ingelheim Investigational Site — Lakewood, California, United States
• 205.346.108 Boehringer Ingelheim Investigational Site — Sepulveda, California, United States
• 205.346.101 Boehringer Ingelheim Investigational Site — Torrance, California, United States
• 205.346.106 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
• 205.346.102 Boehringer Ingelheim Investigational Site — Coeur d'Alene, Idaho, United States
• 205.346.109 Boehringer Ingelheim Investigational Site — Shreveport, Louisiana, United States
• 205.346.110 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 205.346.105 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 205.346.103 Boehringer Ingelheim Investigational Site — Spartanburg, South Carolina, United States
• 205.346.510 — Bs As, Argentina
• 205.346.502 — Buenos Aires, Argentina
• 205.346.503 — Buenos Aires, Argentina
• 205.346.508 — Buenos Airess, Argentina
• 205.346.505 — Mendoza, Argentina
• 205.346.509 — Rosario, Santa Fe, Argentina
• 205.346.511 — Rosario, Santa Fé, Argentina
• 205.346.504 Instituto de Patologías Respiratorias — San Miguel de Tucumán, Argentina
• 205.346.401 Boehringer Ingelheim Investigational Site — Alytus, Lithuania
• 205.346.404 Boehringer Ingelheim Investigational Site — Kaunas, Lithuania
• 205.346.405 Boehringer Ingelheim Investigational Site — Kaunas, Lithuania
• 205.346.411 Boehringer Ingelheim Investigational Site — Klaipėda, Lithuania
• 205.346.409 Boehringer Ingelheim Investigational Site — Šiauliai, Lithuania
• 205.346.408 Boehringer Ingelheim Investigational Site — Utena, Lithuania
• 205.346.402 Boehringer Ingelheim Investigational Site — Vilnius, Lithuania

Full record on ClinicalTrials.gov

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