Clinical trial NCT02172430: Comparison of Tiotropium Inhalation Capsules and Oxitropium Metered Dose Inhalator (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 161
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of Adverse Events
timeFrame: up to 52 weeks
measure: Changes from baseline in Blood Pressure / Heart Rate
timeFrame: up to 52 weeks
measure: Changes from baseline in ECG
timeFrame: up to 52 weeks
measure: Changes from baseline in laboratory tests
timeFrame: up to 52 weeks
Secondary outcomes:
measure: Changes from baseline in Trough Forced expiratory volume in one second (FEV1.0) response
timeFrame: week 24 and 52
measure: Changes from baseline in FEV1.0 at 1 hr post-dosing
timeFrame: week 24 and 52
measure: Changes from baseline in Trough Forced vital capacity (FVC) response
timeFrame: week 24 and 52
measure: Changes from baseline in FVC at 1 hr post-dosing
timeFrame: week 24 and 52
measure: Changes from baseline COPD clinical symptoms (Cough frequency, sputum amount, severity of short breath, nocturnal sleep)
timeFrame: up to 52 weeks
measure: Frequency of rescue use of β2 stimulants
timeFrame: up to 2 weeks
measure: Changes from baseline in Quality of Life QOL (St George's Respiratory Questionnaire (SGRQ) and Airways Questionnaire-20 (AQ20), if possible)
timeFrame: week 24 and 52
measure: Patient's impression
timeFrame: week 24 and 52
measure: Physician's global evaluation
timeFrame: week 24 and 52
Other outcomes:
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