Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.
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| ClinicalTrials.gov Identifier: NCT00388882 |
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Recruitment Status :
Completed
First Posted : October 17, 2006
Last Update Posted : December 28, 2017
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Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Disease, Chronic Obstructive | Drug: tiotropium Drug: ipratropium bromide / albuterol | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 327 participants |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Double-dummy, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium Inhalation Capsules 18 mcg Via the HandiHaler® Once Daily to Combivent® Inhalation Aerosol CFC MDI 2 Actuations q.i.d. in COPD Patients Currently Prescribed Combivent® Inhalation Aerosol CFC MDI |
| Study Start Date : | October 2006 |
| Actual Primary Completion Date : | October 2007 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Tiotropium bromide
Primary Outcome Measures :
- Trough FEV1 [ Time Frame: after 12 weeks of treatment ]
- FEV1 AUC0-6 hours [ Time Frame: after 12 weeks of treatment ]
Secondary Outcome Measures :
- Peak FEV1 [ Time Frame: 12 weeks ]
- Peak FEV1 [ Time Frame: after first dose and 6 week ]
- FEV1 AUC0-6 hours [ Time Frame: after first dose and 6 weeks ]
- Trough FEV1 [ Time Frame: at 6 weeks ]
- Peak FVC at all clinic visits [ Time Frame: 12 weeks ]
- AUC0-6 hours FVC at all clinic visits [ Time Frame: 12 weeks ]
- Trough FVC [ Time Frame: at 6 and 12 weeks ]
- Individual FEV1 measurements [ Time Frame: 12 weeks ]
- Individual FVC measurements [ Time Frame: 12 weeks ]
- Use of Albuterol (scheduled and rescue) [ Time Frame: 12 weeks ]
- Patient Global Evaluation [ Time Frame: 12 weeks ]
- Physician Global Evaluation [ Time Frame: 12 weeks ]
- PEFR (Peak expiratory flow rate) measured by the patient at home twice daily [ Time Frame: 12 weeks ]
- Occurrence of adverse events [ Time Frame: 12 weeks ]
- Vital Signs [ Time Frame: 12 weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388882
Locations
Show 40 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Additional Information:
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00388882 |
| Other Study ID Numbers: |
205.346 EudraCT 2006-000822-30 |
| First Posted: | October 17, 2006 Key Record Dates |
| Last Update Posted: | December 28, 2017 |
| Last Verified: | December 2017 |
Additional relevant MeSH terms:
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Respiratory Aspiration Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases Respiration Disorders Pathologic Processes Lung Diseases, Obstructive Bromides Albuterol Tiotropium Bromide Ipratropium Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Asthmatic Agents Respiratory System Agents Parasympatholytics Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anticonvulsants Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents |