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Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00281567
First received: January 24, 2006
Last updated: May 11, 2012
Last verified: May 2012
History of Changes
  Purpose

Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: Tiotropium
Device: Respimat SMI
Device: HandiHaler
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Double-dummy, Active- and Placebo-controlled, Crossover Efficacy and Safety Comparison of 6-week Treatment Periods of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18 Mcg) Delivered

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).

Secondary Outcome Measures:
  • Comparison of Spiriva HandiHaler to tiotropium 5 mcg as inhalation solution in terms of systemic exposure.

Estimated Enrollment: 64
Study Start Date: August 2002
Estimated Study Completion Date: November 2004
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of COPD
  • FEV1 < 60% predicted
  • FEV1 < 70% of FVC
  • Smoking history of 10 pack-years

Exclusion Criteria:

  • Significant other disease than COPD
  • Recent history of MI (1 year or less)
  • Cardiac arrhythmia requiring drug therapy
  • History of asthma, allergic rhinitis or eosinophil count > 600 mm3
  • Symptomatic prostatic hypertrophy or bladder neck obstruction
  • Known narrow-angle glaucoma
  • Abnormal baseline hematology, blood chemistry or urinalysis
  • History of cancer within last 5 years
  • Life-threatening pulmonary obstruction
  • Cystic fibrosis or bronchiectasis
  • Tuberculosis
  • Pulmonary resection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281567

Locations
Belgium
Boehringer Ingelheim Investigational Site
Study chairs or principal investigators, Belgium
Netherlands
Boehringer Ingelheim Investigational Site
Study chairs or principal investigators, Netherlands
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim KG
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00281567     History of Changes
Other Study ID Numbers: 205.250
Study First Received: January 24, 2006
Last Updated: May 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory Aspiration
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Disease Attributes
Pathologic Processes
Tiotropium
Parasympatholytics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013