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Tiotropium and Salmeterol PK Study in COPD Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00673478
First received: May 6, 2008
Last updated: July 22, 2009
Last verified: July 2009
History of Changes
  Purpose

The primary objective of this study is to characterize the pharmacokinetics (i.e. systemic exposure to tiotropium and salmeterol) of tiotropium qd + salmeterol qd or bid versus tiotropium qd and salmeterol bid following 4-week treatment periods in patients with chronic obstructive pulmonary disease (COPD).


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: Tiotropium+Salmeterol
Drug: Salmeterol
Drug: Tiotropium
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: A Randomised, Open-label, 4-way Crossover Study to Characterize the Pharmacokinetics, Safety and Efficacy of Tiotropium and Salmeterol After Inhalation of Tiotropium qd + Salmeterol qd or Bid, Tiotropium qd and Salmeterol Bid

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacokinetics of tiotropium and salmeterol. [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • 1) Pharmacokinetics 2) Safety and tolerability 3) Efficacy [ Time Frame: 16 weeks ]

Enrollment: 50
Study Start Date: May 2008
Primary Completion Date: June 2009 (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:

COPD patients of >= 40 years old with moderate to severe COPD who are current or ex-smokers with a smoking history of at least 10 pack-years

Exclusion Criteria:

  1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
  2. History of asthma
  3. Malignancy requiring treatment within past 5 years
  4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
  5. Known active tuberculosis
  6. Pregnant or nusing women
  7. Known hypersensitivity to components of the study medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673478

Locations
Belgium
1184.24.32001 Boehringer Ingelheim Investigational Site
Genk, Belgium
1184.24.32002 Boehringer Ingelheim Investigational Site
Hasselt, Belgium
Netherlands
1184.24.31001 Boehringer Ingelheim Investigational Site
Heerlen, Netherlands
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00673478     History of Changes
Other Study ID Numbers: 1184.24, EudraCT 2007-000207-15
Study First Received: May 6, 2008
Last Updated: July 22, 2009
Health Authority: Belgium: Federal Agency for Medicines and Health Products
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Salmeterol
Tiotropium
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 19, 2013