Tiotropium and Salmeterol Pharmacokinetics Study in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study is currently recruiting participants.

Verified by Boehringer Ingelheim Pharmaceuticals, December 2008

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00673478

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 III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium Tiotropium bromide Salmeterol Salmeterol xinafoate Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Crossover Assignment, Pharmacokinetics Study
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

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 ]

Estimated Enrollment:	51
Study Start Date:	May 2008
Estimated 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:

Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
History of asthma
Malignancy requiring treatment within past 5 years
Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
Known active tuberculosis
Pregnant or nursing women
Known hypersensitivity to components of the study medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673478

Contacts

Contact: Boehringer Ingelheim Study Coordinator

800-542-6257 ext Option 4

clintriage.rdg@boehringer-ingelheim.com

Locations

Belgium
1184.24.32001 Boehringer Ingelheim Investigational Site	Active, not recruiting
Genk, Belgium
1184.24.32002 Boehringer Ingelheim Investigational Site	Active, not recruiting
Hasselt, Belgium
Netherlands
1184.24.31001 Boehringer Ingelheim Investigational Site	Recruiting
heerlen, Netherlands

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1184.24, EudraCT 2007-000207-15
Study First Received:	May 6, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00673478
Health Authority:	Belgium: Federal Agency for Medicines and Health Products; Netherlands: Central Committee on Research Involving Human Subjects (CCMO); United States: Food and Drug Administration

Study placed in the following topic categories:

Salmeterol
Respiration Disorders
Naphazoline
Oxymetazoline
Lung Diseases, Obstructive
Respiratory Tract Diseases
Phenylephrine

Guaifenesin
Lung Diseases
Chronic Disease
Phenylpropanolamine
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Parasympatholytics
Respiratory System Agents
Disease Attributes
Neurotransmitter Agents
Cholinergic Antagonists
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Anti-Asthmatic Agents
Cholinergic Agents
Adrenergic Agonists
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009