The Effects of Tiotropium on the Cough Reflex in Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

Does tiotropium effect the cough reflex in patients with COPD and chronic bronchitis.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ThomasTruncale
• Collaborator: Boehringer Ingelheim
• Treatments: Capsaicin; Tiotropium Bromide

Criteria

Inclusion Criteria:

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 Criteria:Exclusion Criteria: Subjects will not be eligible for the study if they are

• Age of < 40 or > 80 years.

• Refusal to volunteer for the study and not willing to sign the informed consent form.

• Respiratory disorder other than COPD including asthma, chronic bronchiectasis or pulmonary fibrosis

• Oxygen or ventilator dependent COPD.

• Received any antibiotics or had a change in their inhaled steroid dose during the last 4 weeks. 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.

• History of Congestive heart failure, cardiomyopathy, valvular heart disease, angina, cardiac arrhythmia, or myocardial infarction within the last 6 months or poorly controlled hypertension.

• History of chronic hepatitis or hepatic cirrhosis.

• End-stage renal disease.

• History of neurologic or psychiatric disorder which would interfere with completion of the study.

• Physician diagnosis of Gastroesophageal reflux disease

• Physician diagnosis of allergic, non-allergic rhinitis, or sinusitis

• History of lung cancer

• History of radiation treatment to the chest or mediastinum

• Lung volume reduction surgery, segmentectomy, lobectomy or pneumonectomy

• History of a thoracotomy

• Symptomatic Benign prosthetic hypertrophy

• Symptomatic bladder outlet obstruction

• Symptomatic glaucoma

• Severe COPD defined as a postbronchodilator FEV1/FVC ratio of < 0.7 and a predicted FEV1 of 30-50%. Very severe COPD defined as a postbronchodilator FEV1/FVC ratio of <0.7 and a predicted FEV1 of < 30%. (Eur Respir J 2004; 23: 932-946).

• Within the previous one month (30 days) prior to beginning the study, used or continue to use ipratropium or tiotropium

• Allergic response or history of allergy to lactose