Tiotropium and Salmeterol PK Study in COPD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Interventions

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Tiotropium+Salmeterol

Intervention Type DRUG

Salmeterol

Intervention Type DRUG

Tiotropium

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No