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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:
ClinicalTrials.gov Identifier:
NCT00281567
First Posted: January 25, 2006
Last Update Posted: November 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  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
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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:
  • Trough forced vital capacity (FVC) response after 4 weeks (change from baseline) [ Time Frame: baseline until week 28 ]
  • Peak response (FEV1 and FVC) to first dose [ Time Frame: within 3 hours to first dose ]
  • Peak response (FEV1 and FVC) after 4 weeks [ Time Frame: within 3 hours after 4 weeks ]
  • FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks [ Time Frame: after 4 weeks ]
  • FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks [ Time Frame: after first dose and after 4 weeks ]
  • Individual FEV1and FVC measurements at each time point [ Time Frame: up to 28 weeks ]
  • Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients [ Time Frame: up to 28 weeks ]
  • Number of occasions of rescue therapy used as required (p.r.n. salbutamol) [ Time Frame: up to 28 weeks ]
  • Median time to onset of therapeutic response after first dose [ Time Frame: after 4 weeks ]
  • Number of patients with 15% response above baseline for each treatment at each timepoint after first dose [ Time Frame: at week 4, 12, 20 ]
  • Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks [ Time Frame: at week 8, 16, 24 ]

Enrollment: 76
Study Start Date: August 2002
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
  Eligibility

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim KG
  More Information

ClinicalTrials.gov Identifier: NCT00281567     History of Changes
Other Study ID Numbers: 205.250
First Submitted: January 24, 2006
First Posted: January 25, 2006
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Tiotropium Bromide
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