Efficacy and Safety of Tiotropium Inhalation Capsules and Atrovent MDI in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00274092 | Completed Phase 3

• 1 other identifier: 205.279
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 6

Brief Summary

The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 mcg once daily) and Atrovent 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)

• The primary endpoint is trough FEV1 response which is defined as change from baseline FEV1 (visit 2) and trough FEV1 at week 4 (visit 4)

Secondary Outcomes (1)

• FEV1 and FVC response at 2 hours post drug administration at on each pulmonary test day; Trough FVC response; Number of rescue medications; and Change from baseline in total score of patient evaluation questionnaire at week 4 (visit 4).

Interventions

tiotropium inhalation capsules (18 mcg once daily) DRUG

Atrovent MDI (2 puffs of 20 mcg(q.i.d.) in patients DRUG

Eligibility Criteria

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

You may qualify if:

• COPD patients with an Forced Expiratory Volume in one second (FEV1)\<= 65% of predicted normal and FEV1 \<= 70% of Forced Vital Capacity (FVC).
• 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 upper normal limit, bilirubin 150% or creatinine 125% of the upper normal limit 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.
• Any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
• 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 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.
• Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction. (Patients on BPH medications with minimum symptoms are permitted).
• 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 dosage (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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (6)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Veterans General Hospital

Taichung, 407, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Veterans General Hospital

Taipei, 12217, Taiwan

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

  B.I. Taiwan 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: September 1, 2002
• Primary Completion: October 1, 2003
• Study Completion: October 1, 2003
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

TW (6)