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
ClinicalTrials.gov Identifier:
NCT00281567
First received: January 24, 2006
Last updated: October 31, 2013
Last verified: October 2013
  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, 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 ] [ Designated as safety issue: No ]
  • Peak response (FEV1 and FVC) to first dose [ Time Frame: within 3 hours to first dose ] [ Designated as safety issue: No ]
  • Peak response (FEV1 and FVC) after 4 weeks [ Time Frame: within 3 hours after 4 weeks ] [ Designated as safety issue: No ]
  • FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Individual FEV1and FVC measurements at each time point [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
  • Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
  • Number of occasions of rescue therapy used as required (p.r.n. salbutamol) [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
  • Median time to onset of therapeutic response after first dose [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with 15% response above baseline for each treatment at each timepoint after first dose [ Time Frame: at week 4, 12, 20 ] [ Designated as safety issue: No ]
  • Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks [ Time Frame: at week 8, 16, 24 ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: August 2002
Primary Completion Date: July 2003 (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
  • 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
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: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00281567     History of Changes
Other Study ID Numbers: 205.250
Study First Received: January 24, 2006
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014