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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172430
• Other study ID #: 205.227
• Status: Completed
• Phase: Phase 3
• Start date: September 2000

Study information

• Verified date: August 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. primary completion date: May 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium powder inhalation capsules
Powder inhalation via the HandiHaler® once daily
• Tersigan®
2 puffs of oxitropium three times daily via MDI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Adverse Events		up to 52 weeks
Primary	Changes from baseline in Blood Pressure / Heart Rate		up to 52 weeks
Primary	Changes from baseline in ECG		up to 52 weeks
Primary	Changes from baseline in laboratory tests		up to 52 weeks
Secondary	Changes from baseline in Trough Forced expiratory volume in one second (FEV1.0) response		week 24 and 52
Secondary	Changes from baseline in FEV1.0 at 1 hr post-dosing		week 24 and 52
Secondary	Changes from baseline in Trough Forced vital capacity (FVC) response		week 24 and 52
Secondary	Changes from baseline in FVC at 1 hr post-dosing		week 24 and 52
Secondary	Changes from baseline COPD clinical symptoms (Cough frequency, sputum amount, severity of short breath, nocturnal sleep)		up to 52 weeks
Secondary	Frequency of rescue use of ß2 stimulants		up to 2 weeks
Secondary	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
Secondary	Patient's impression		week 24 and 52
Secondary	Physician's global evaluation		week 24 and 52