Status:
COMPLETED
Comparison of Tiotropium and Ipratropium in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults With COPD
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
Comparison of 18 mcg of Tiotropium Inhalation Capsules and ipratropiumMetered Dose Inhaler (2 puffs of 20 mcg, four times daily) in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults wi...
Detailed Description
This is a 2-treatment, randomized, double-blind, parallel design trial in adult patient with COPD. Each dose of tiotropium or placebo will consist of one capsule self administered from the HandiHaler...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- All patients must have a diagnosis of chronic obstructive pulmonary disease according to the following criteria:
- Patients must have relatively stable airway obstruction with an FEV1 \>= 65% of predicted normal and FEV1 70% of FVC. "Predicted normal values will be based on formulas as supplied by the individual study sites."
- Male or female patients 40 years of age or older.
- Patients must have a smoking history of more than 10 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 pulmonary function tests as required in the protocol.
- Patients must be able to inhale medication from the HandiHaler device and should have a good technique of inhaling aerosol administered from an MDI.
- All patients must sign an Informed Consent Form prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications
- 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 hematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded.
- All patients with a SGOT and SGPT twice the normal range, bilirubin 150% or creatinine 125% of the normal range will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these subjects.
- 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 or patients with any cardiac arrhythmia requiring drug therapy.
- 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 pulmonary resection or a thoracotomy for any reason.
- Patients with an upper respiratory tract infection in the past 6 weeks prior to the Screening Visit (=Visit 1) or during the baseline period of 2-weeks (run-in period).
- Patients with known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule delivery system or the MDI
- 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.
- Patients using oral corticosteroid medication at unstable (i.e. less than 6 weeks on a stable dose) or at a dose in excess of the equivalent 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 (e.g. oral contraceptives, intrauterine devices, or diaphragm).
- Patients with a history of asthma, allergic rhinitis or atopy or who have a blood total eosinophil count 400\>= per mcl (males) or 320\>= per mcl (females). A repeat eosinophil count will not be conducted in these patients.
- Patients with a history and/or active alcohol or drug abuse.
- Patients who have taken an investigational drug one month or six half-lives (whichever is greater) prior to the Screening Visit (=Visit 1).
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
March 1 2003
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00274040
Start Date
July 1 2002
End Date
March 1 2003
Last Update
November 1 2013
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Chungnam National University Hospital
Daejeon, South Korea
2
Jeonbuk National University Hospital
Jeonju, South Korea
3
Jeonnam National University Hospital
Kwangju, South Korea
4
Pusan University Hospital
Pusan, South Korea