Status:
COMPLETED
The Effects of Tiotropium on the Cough Reflex in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
ThomasTruncale
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Eligibility:
MALE
40-80 years
Phase:
EARLY_PHASE1
Brief Summary
Does tiotropium effect the cough reflex in patients with COPD and chronic bronchitis.
Detailed Description
Cough Questionnaire This questionnaire is designed to assess the impact of cough on various aspects of your life. Read each question carefully and answer by CIRCLING the response that best applies to...
Eligibility Criteria
Inclusion
- After signing the informed consent, screening testing will be done to document that a subject meets the requirements of the study. Specific inclusion criteria are:
- Subjects between the ages of 40 and 80 years of age (Dates of Birth 1925-1965)
- Current smoker (with smoking history of \> 10 pack/year) or ex-smoker (stopped within 1 year and has at least a 10 pack/year smoking history).
- Subjects will be included if they meet criteria for mild and moderate COPD as defined by the American Thoracic Society and European Respiratory Society position paper. Mild COPD will be defined as a postbronchodilator (2 puffs of albuterol) FEV1/FVC ratio of \<0.7 and a predicted FEV1 of \> 80%. Moderate COPD will be defined as a postbronchodilator FEV1/FVC ratio of \<0.7 and a predicted FEV1 50-80%. A response to bronchodilators is defined as an increase of 12% or 200cc in FEV1 from baseline after inhalation of 2 puffs of albuterol. Both subjects with and without a response to bronchodilators will be included in the study.
- All subjects will be clinically stable for 4 weeks prior to inclusion. Clinical stability is defined as having no recent COPD exacerbations within the last 4 weeks and having received no antibiotics or change in their inhaled steroid dose during that time period. If a subject is on oral steroids, they will be required to be on 10 mg or less each day or no more than 20mg every other day to be eligible. If the oral steroid dose has been titrated over the previous 4 weeks (either up or down) or if the dose is higher than what has been described previously, they will be ineligible for the study.
- All subjects will be off of tiotropium or ipratropium for 1 month prior to the start of the study.
- Chronic cough: Chronic cough will be characterized by the presence of a productive cough for 3 months in each of 2 successive years in persons in whom other causes of chronic cough have been excluded.
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00870896
Start Date
February 1 2008
End Date
June 1 2012
Last Update
October 1 2014
Active Locations (2)
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1
James A Haley Veterans' Hospital
Tampa, Florida, United States, 33612
2
University of South Florida (COPH)
Tampa, Florida, United States, 33612