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

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium powder inhalation capsules; Drug: Tersigan®

• Registration Number: NCT02172430
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2002-05
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-24
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tiotropium	Tiotropium powder inhalation capsules	-
Oxitropium bromide	Tersigan®	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Changes from baseline in Trough Forced vital capacity (FVC) response	week 24 and 52
Changes from baseline COPD clinical symptoms (Cough frequency, sputum amount, severity of short breath, nocturnal sleep)	up to 52 weeks
Physician's global evaluation	week 24 and 52
Changes from baseline in FEV1.0 at 1 hr post-dosing	week 24 and 52
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
Changes from baseline in Trough Forced expiratory volume in one second (FEV1.0) response	week 24 and 52
Changes from baseline in FVC at 1 hr post-dosing	week 24 and 52
Patient's impression	week 24 and 52