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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00388882
First received: October 16, 2006
Last updated: October 31, 2013
Last verified: October 2013
  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, 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough FEV1 [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC0-6 hours [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak FEV1 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Peak FEV1 [ Time Frame: after first dose and 6 week ] [ Designated as safety issue: No ]
  • FEV1 AUC0-6 hours [ Time Frame: after first dose and 6 weeks ] [ Designated as safety issue: No ]
  • Trough FEV1 [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
  • Peak FVC at all clinic visits [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • AUC0-6 hours FVC at all clinic visits [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Trough FVC [ Time Frame: at 6 and 12 weeks ] [ Designated as safety issue: No ]
  • Individual FEV1 measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Individual FVC measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Use of Albuterol (scheduled and rescue) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patient Global Evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Physician Global Evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • PEFR (Peak expiratory flow rate) measured by the patient at home twice daily [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Vital Signs [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 327
Study Start Date: October 2006
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388882

  Show 40 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
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: October 31, 2013
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:
Respiratory Aspiration
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Disease Attributes
Lung Diseases, Obstructive
Albuterol
Ipratropium
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on August 28, 2014