Efficacy and Safety of Tiotropium Compared to Salmeterol and Placebo in Patients With Chronic Obstructive Bronchitis (COPD)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to compare the long-term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo inpatients with COPD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Salmeterol Xinafoate; Tiotropium Bromide

Criteria

Inclusion Criteria:

• Age ≥ 40 years.

• A diagnosis of relatively stable, moderate to severe COPD with:

• Screening FEV1 ≤ 60% of predicted normal value (calculated according to European Community for Coal and Steel (ECCS) criteria and screening FEV1/FVC ≤ 70%

• Smoking history ≥ 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent)

• Ability to be trained in the proper use of the HandiHaler® device and Metered Dose Inhaler (MDI).

• Ability to perform all study related tests including the Shuttle Walking Test, acceptable pulmonary function tests, including Peak expiratory flow rate (PEFR) measurements, and maintenance of diary card records.

• Ability to give written informed consent in accordance with Good Clinical Practice and local regulations.

Exclusion Criteria:

• Clinically significant diseases other than COPD.

• Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion, will be excluded.

• All patients with a serum glutamic oxaloacetic transaminase (SGOT) > 80 IU/L, serum glutamic pyruvic transaminase (SGPT) > 80 IU/L, bilirubin >2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition.

• A recent history (i.e., one year or less) of myocardial infarction.

• Any cardiac arrhythmia requiring drug therapy or hospitalisation for heart failure within the past three years.

• Inability to abstain from regular daytime use of oxygen therapy for more than 1 hour per day.

• Known active tuberculosis.

• History of cancer within the last five years (excluding basal cell carcinoma)

• History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.

• Patients who have undergone thoracotomy with pulmonary resection.

• Any upper respiratory infection in the past six weeks prior to the screening visit or during the run-in period.

• Current participation in a pulmonary rehabilitation programme or completion of a pulmonary rehabilitation programme in the six week prior to the screening visit.

• Known hypersensitivity to anticholinergic drugs, salmeterol, or any of the components of the lactose powder capsule or MDI delivery systems.

• Known symptomatic prostatic hypertrophy or bladder neck obstruction.

• Patients with known narrow-angle glaucoma.

• Current treatment with cromolyn sodium or nedocromil sodium.

• Current treatment with antihistamines (H1 receptor antagonists).

• Oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day.

• Current use of β-blocker medication.

• Current treatment with monoamine oxidase inhibitors or tricyclic antidepressants.

• 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 > 600mm3.

• History of and/or active significant alcohol or drug abuse.

• Concomitant or recent use of an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit.

• Changes in the pulmonary therapeutic plan within the six weeks prior to the screening visit.

• Inability to comply with the medication restrictions specified in Section 4.2 of the trial protocol