Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00388882
First received: October 16, 2006
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: tiotropium Drug: ipratropium bromide / albuterol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium 18 Mcg Daily With Combivent MDI 2 Actuations Qid |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Albuterol
Ipratropium bromide
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
Tiotropium bromide
Levalbuterol tartrate
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388882
Show 40 Study Locations
Show 40 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
Related Info 
Related Info 
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00388882 History of Changes |
| Other Study ID Numbers: | 205.346, EudraCT 2006-000822-30 |
| Study First Received: | October 16, 2006 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnología) Great Britain: MHRA Lithuania: State Medicines Control Agency, LT-01132 Vilnius Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Lung Diseases, Obstructive Albuterol Ipratropium Tiotropium Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Cholinergic Antagonists Cholinergic Agents Parasympatholytics |
ClinicalTrials.gov processed this record on May 19, 2013