effect of tiotropium on airway diameter in patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: trial to investigate the acute and chronic effect of tiotropium therapy on airway diameter in copd patients as measured by inspiratory capacity (ic).


Eligibility criteria:
inclusion criteria: * all patients must have a diagnosis of chronic obstructive pulmonary disease * male or female patients ≥ 40 years of age but ≤ 75 years old * patients must have a smoking history of more than ten pack-years. a pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year * patients must be able to perform all specified procedures and maintain records during the study period as required in the protocol * patients must be able to inhale medication from the handihaler® * all patients must sign a patient informed consent form prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications * patients must be willing to attend an outpatient clinic on a regular basis * patients must be able to walk 164 feet (50 meters) during the six minute walk test exclusion criteria: * patients with significant diseases other than copd will be excluded. a significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study * patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis test results, if the abnormality defines a disease listed as an exclusion criterion * patients with a serum glutamic-oxaloacetic transaminase (sgot) ≥1.5 x upper limit of normal range (uln), serum glutamic-pyruvic transaminase (sgpt) ≥1.5 x uln, bilirubin ≥1.5 x uln or creatinine ≥ 1.5 x uln regardless of the clinical condition * patients with a recent history (i.e., one year or less) of myocardial infarction * patients with a recent history (i.e., three years or less) of heart failure, pulmonary edema or patients with any cardiac arrhythmia (with or without symptoms) * patients with regular use of daytime oxygen therapy * patients with known active tuberculosis * patients with a history of cancer within the last five years. patients with treated basal cell carcinoma are allowed * patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis * patients who have undergone thoracotomy with pulmonary resection. patients with a history or a thoracotomy for other reason should be evaluated as per exclusion criterion no. 1 * patients with upper respiratory tract infection in the past six weeks prior to the screening visit or during the baseline period * patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system * patients with known symptomatic prostatic hypertrophy or bladder neck obstruction * patients with known narrow-angle glaucoma * patients who are being treated with cromolyn sodium or nedocromil sodium * patients who are being treated with antihistamines (h1 receptor antagonists) or antileukotrienes and are not able to stop these medications 1 month before visit 1 * patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day * pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception * patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥ 600/mm3 * patients with history of (past five years or less) and/or active alcohol or drug abuse * patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening period (visit 1) * patients who have participated in any pulmonary rehabilitation program for copd within 6 weeks prior to visit 1 or throughout the study * limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea such as arthritis in the leg, angina or claudication