Comparison of Tiotropium Inhalation Capsules and Oxitropium Metered Dose Inhalator (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Multiple Dose Comparison of Tiotropium 18 μg Inhalation Capsules and Oxitropium MDI (2 Puffs of 100 μg) in a One-year, Open-Label, Safety and Efficacy Study in Patients With COPD

The objective of this study is to investigate the long-term safety of Ba 79 BR (tiotropium) powder inhalation in patients with COPD using oxitropium bromide (Tersigan) as a comparator. Secondarily, the long-term efficacy of Ba 679 BR is also investigated

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Tiotropium powder inhalation capsules; Drug: Tersigan®

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

The patients with COPD (chronic bronchitis, emphysema) whose symptoms are stable and who satisfy the following criteria

1. Patients with FEV1.0 of <=70% of predicted normal and FEV1.0/FVC of <=70% in the screening test (The FEV1.0 value should also be <=70% of predicted normal on the starting day of administration (visit 2).)
2. Patients with a smoking history (<number of cigarettes smoked a day x number of smoking years> is >=200.)
3. Male or female patients aged >=40 years old

Exclusion Criteria:

1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
2. Patients using oral corticosteroid medication at a dose in excess of the equivalent 10 mg/day of prednisolon
3. Patients with glaucoma
4. Patients with symptomatic prostatic hypertrophy
5. Patients with hypersensitivity to anticholinergic drugs or powder inhalants
6. Patients with serious complication who are judged by the investigator to be inappropriate as the subjects of study
7. Patients demonstrating clinically problematic abnormal laboratory test values (general blood test, biochemical test, urinalysis). Those showing Glutamic Oxaloacetic Transaminase (GOT) and Glutamic PyruvicTransaminase (GPT) twice the upper limit of the normal range, bilirubin 1.25 times or creatinine 1.25 times of the upper limit of normal range are excluded.
8. Patients with a recent history of myocardial infarction or heart failure (i.e. within 3 months before the screening test)
9. Patients with arrhythmia requiring the treatment with drugs
10. Patients for whom the concomitant use of beta-blocker cannot be prohibited.
11. Patients who began treatment with an ACE inhibitor within 1 month before the screening test
12. Patients with tuberculosis (currently active) or with definite sequela of tuberculosis
13. Patients with a recent history of carcinoma (excluding basal cell carcinoma) (i.e. within the past 5 years)
14. Patients with a history of cystic fibrosis and bronchiectasis
15. Patients with recent onset of upper airway infection (i.e. within 1 month before the screening test)
16. Patients who have taken an investigational drug within one month or within period six times of half-lives of that drug (whichever is longer) before the screening test.
17. Women who are pregnant or who may become pregnant, or those breast feeding
18. Other than above, those who are judged by the investigator to be inappropriate as the subjects of study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tiotropium	Drug: Tiotropium powder inhalation capsules; Powder inhalation via the HandiHaler® once daily
Active Comparator: Oxitropium bromide	Drug: Tersigan®; 2 puffs of oxitropium three times daily via MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of Adverse Events	up to 52 weeks
Changes from baseline in Blood Pressure / Heart Rate	up to 52 weeks
Changes from baseline in ECG	up to 52 weeks
Changes from baseline in laboratory tests	up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in Trough Forced expiratory volume in one second (FEV1.0) response	week 24 and 52
Changes from baseline in FEV1.0 at 1 hr post-dosing	week 24 and 52
Changes from baseline in Trough Forced vital capacity (FVC) response	week 24 and 52
Changes from baseline in FVC at 1 hr post-dosing	week 24 and 52
Changes from baseline COPD clinical symptoms (Cough frequency, sputum amount, severity of short breath, nocturnal sleep)	up to 52 weeks
Frequency of rescue use of β2 stimulants	up to 2 weeks
Changes from baseline in Quality of Life QOL (St George's Respiratory Questionnaire (SGRQ) and Airways Questionnaire-20 (AQ20), if possible)	week 24 and 52
Patient's impression	week 24 and 52
Physician's global evaluation	week 24 and 52

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info
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Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Primary Completion (Actual): May 1, 2002

Study Registration Dates

• First Submitted: June 20, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: 205.227