Comparison of Tiotropium Inhalation Capsules and Oxitropium Metered Dose Inhalator (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tiotropium powder inhalation capsules
Tersigan®
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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)
- 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.
- Women who are pregnant or who may become pregnant, or those breast feeding
- Other than above, those who are judged by the investigator to be inappropriate as the subjects of study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tiotropium
Oxitropium bromide
Arm Description
Outcomes
Primary Outcome Measures
Occurrence of Adverse Events
Changes from baseline in Blood Pressure / Heart Rate
Changes from baseline in ECG
Changes from baseline in laboratory tests
Secondary Outcome Measures
Changes from baseline in Trough Forced expiratory volume in one second (FEV1.0) response
Changes from baseline in FEV1.0 at 1 hr post-dosing
Changes from baseline in Trough Forced vital capacity (FVC) response
Changes from baseline in FVC at 1 hr post-dosing
Changes from baseline COPD clinical symptoms (Cough frequency, sputum amount, severity of short breath, nocturnal sleep)
Frequency of rescue use of β2 stimulants
Changes from baseline in Quality of Life QOL (St George's Respiratory Questionnaire (SGRQ) and Airways Questionnaire-20 (AQ20), if possible)
Patient's impression
Physician's global evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02172430
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
May 2002 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tiotropium
Arm Type
Experimental
Arm Title
Oxitropium bromide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tiotropium powder inhalation capsules
Intervention Description
Powder inhalation via the HandiHaler® once daily
Intervention Type
Drug
Intervention Name(s)
Tersigan®
Intervention Description
2 puffs of oxitropium three times daily via MDI
Primary Outcome Measure Information:
Title
Occurrence of Adverse Events
Time Frame
up to 52 weeks
Title
Changes from baseline in Blood Pressure / Heart Rate
Time Frame
up to 52 weeks
Title
Changes from baseline in ECG
Time Frame
up to 52 weeks
Title
Changes from baseline in laboratory tests
Time Frame
up to 52 weeks
Secondary Outcome Measure Information:
Title
Changes from baseline in Trough Forced expiratory volume in one second (FEV1.0) response
Time Frame
week 24 and 52
Title
Changes from baseline in FEV1.0 at 1 hr post-dosing
Time Frame
week 24 and 52
Title
Changes from baseline in Trough Forced vital capacity (FVC) response
Time Frame
week 24 and 52
Title
Changes from baseline in FVC at 1 hr post-dosing
Time Frame
week 24 and 52
Title
Changes from baseline COPD clinical symptoms (Cough frequency, sputum amount, severity of short breath, nocturnal sleep)
Time Frame
up to 52 weeks
Title
Frequency of rescue use of β2 stimulants
Time Frame
up to 2 weeks
Title
Changes from baseline in Quality of Life QOL (St George's Respiratory Questionnaire (SGRQ) and Airways Questionnaire-20 (AQ20), if possible)
Time Frame
week 24 and 52
Title
Patient's impression
Time Frame
week 24 and 52
Title
Physician's global evaluation
Time Frame
week 24 and 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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.
Women who are pregnant or who may become pregnant, or those breast feeding
Other than above, those who are judged by the investigator to be inappropriate as the subjects of study
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.227.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.227_literature.pdf
Description
Related Info
Learn more about this trial
Comparison of Tiotropium Inhalation Capsules and Oxitropium Metered Dose Inhalator (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
We'll reach out to this number within 24 hrs