A Comparison of 18g of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler (2 Puffs of 20g, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)

NCT00239434 | Completed Phase 3

• 1 other identifier: 205.245
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

Brief Summary

The objective of this study is to compare the bronchodilator efficacy and safety of once daily dosing of tiotropium inhalation capsules (18 ?g) and Atrovent? MDI (2 puffs of ipratropium bromide 20 ?g four times daily) in patients with chronic obstructive pulmonary disease.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Trough FEV1 response: change from baseline trough FEV1 (visit 2) at visit 4

Secondary Outcomes (1)

• Trough FEV1 response at visit 3 Average FEV1 (AUC0-3) response (change from baseline) for the 3 hours post drug administration Trough FVC response Average FVC (AUC0-3) response (as defined for FEV1) 5. Amount of rescue medication 6. Patient questionnaire

Interventions

tiotropium inhalation powder capsule DRUG

ipratropium bromide Metered Dose Inhaler DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 the following formula. Males: FEV1 pred.(L) = height2(m) x (-0.016 x age(year) + 1.823) Females: FEV1 pred.(L) = height2(m) x (-0.012 x age(year) + 1.4427)
• 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.

You may not qualify if:

• 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.
• 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.
• 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 hyperplasia 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (6)

People Hospital of Beijing University

Beijing, 100044, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

1st Hospital of Guangzhou Medical College

Guangzhou, 510120, China

Location

Zhongshan Hospital of Fudan University

Shanghai, 200032, China

Location

Shanghai 1st People Hospital

Shanghai, 200080, China

Location

1st Hospital of Chinese Medical University

Shenyang, 110001, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim Shanghai

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 17, 2005
• Study Start: June 1, 2003
• Study Completion: March 1, 2004
• Last Updated: May 14, 2012

Record last verified: 2012-05

Locations

CN (6)