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

NCT02172430 | Completed Phase 3

• 1 other identifier: 205.227
• Study Type: interventional
• Target: 161
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• 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

Study Arms (2)

Tiotropium

EXPERIMENTAL

Drug: Tiotropium powder inhalation capsules

Oxitropium bromide

ACTIVE COMPARATOR

Drug: Tersigan®

Interventions

Tiotropium powder inhalation capsules DRUG

Powder inhalation via the HandiHaler® once daily

Tiotropium

Tersigan® DRUG

2 puffs of oxitropium three times daily via MDI

Oxitropium bromide

Eligibility Criteria

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

You may qualify if:

• The patients with COPD (chronic bronchitis, emphysema) whose symptoms are stable and who satisfy the following criteria
• 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).)
• Patients with a smoking history (\<number of cigarettes smoked a day x number of smoking years\> is \>=200.)
• Male or female patients aged \>=40 years old

You may not qualify if:

• Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
• Patients using oral corticosteroid medication at a dose in excess of the equivalent 10 mg/day of prednisolon
• Patients with glaucoma
• Patients with symptomatic prostatic hypertrophy
• Patients with hypersensitivity to anticholinergic drugs or powder inhalants
• Patients with serious complication who are judged by the investigator to be inappropriate as the subjects of study
• 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.
• Patients with a recent history of myocardial infarction or heart failure (i.e. within 3 months before the screening test)
• Patients with arrhythmia requiring the treatment with drugs
• Patients for whom the concomitant use of beta-blocker cannot be prohibited.
• Patients who began treatment with an ACE inhibitor within 1 month before the screening test
• Patients with tuberculosis (currently active) or with definite sequela of tuberculosis
• Patients with a recent history of carcinoma (excluding basal cell carcinoma) (i.e. within the past 5 years)
• Patients with a history of cystic fibrosis and bronchiectasis
• Patients with recent onset of upper airway infection (i.e. within 1 month before the screening test)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: September 1, 2000
• Primary Completion: May 1, 2002
• Last Updated: August 31, 2018

Record last verified: 2018-08