Comparison of Tiotropium and Ipratropium in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults With COPD

NCT00274040 | Completed Phase 3

• 1 other identifier: 205.244
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 18

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 with Chronic Obstructive Pulmonary Disease (COPD). The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 mcg once daily) and ipratropium MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD).

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (11)

• FEV1 (AUC0-3) response (change from baseline) for the 3 hours post drug administration

  4 weeks

• Trough FVC response

  4 weeks

• FVC (AUC0-3) response (as defined for FEV1)

  4 weeks

• Patient questionnaire

  4 weeks

• Daily PEFR

  4 weeks

Interventions

Tiotropium DRUG

Ipratropium 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 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

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 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (18)

Chungnam National University Hospital

Daejeon, South Korea

Location

Jeonbuk National University Hospital

Jeonju, South Korea

Location

Jeonnam National University Hospital

Kwangju, South Korea

Location

Pusan University Hospital

Pusan, South Korea

Location

Chung-ang University Hospital

Seoul, South Korea

Location

Hanyang University Hosital

Seoul, South Korea

Location

Kangnam St. Mary's Hospital

Seoul, South Korea

Location

Korea University Hospital

Seoul, South Korea

Location

Kyoungbuk National University Hospital

Seoul, South Korea

Location

Kyunghee University Hospital

Seoul, South Korea

Location

National Medical Center

Seoul, South Korea

Location

Samsung Seoul Hospital

Seoul, South Korea

Location

Seoul Asan Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Shinchon Severence Hosp (Yonsei University Hosp)

Seoul, South Korea

Location

St. Paul's Hospital, Dept. of Respiratory

Seoul, South Korea

Location

Youngdong Sevarence Hospital (Yonsei University Hospital)

Seoul, South Korea

Location

Wonju Christian Hospital (Yonsei University Hosp)

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; Ipratropium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Atropine Derivatives; Belladonna Alkaloids; Solanaceous Alkaloids

Study Officials

• Boehringer Ingelheim Study Coordinator

  B.I. Korea Ltd.

  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: January 9, 2006
• First Posted: January 10, 2006
• Study Start: July 1, 2002
• Primary Completion: March 1, 2003
• Study Completion: March 1, 2003
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

KR (18)