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A Randomised, Double-blind, Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Ba 679 BR Respimat
Tiotropium (Spiriva) inhalation capsule 18 ug
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

participation in the trial 2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: ? Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 =< 70% of predicted normal* and FEV1 =< 70% of FVC (Visits 1 and 2). *: Predicted normal values will be calculated according to the formulas for Japanese predicted normal values (R05-0607) (see below). Males: FEV1 predicted (L) = 0.036 x (height (cm)) ? 0.028 x age (years) ? 1.178 Females: FEV1 predicted (L) = 0.022 x (height (cm)) ? 0.022 x age (years) ? 0.005 ? Patients must maintain stable COPD medications for 1 month prior to Visit 1. 3. Male or female patients 40 years of age or older. 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Pack Years = [Number of cigarettes/ day / 20] x years of smoking 5. Patients must be able to perform technically acceptable pulmonary function tests. 6. Patients must be able to inhale medication in a competent manner from the Respimat inhaler and the HandiHaler. Patients with/who: Significant diseases except COPD Clinically relevant abnormal haematology, blood chemistry, or urinalysis Recent history of MI Any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past 3 yrs Cancer within the last 5 yrs Symptomatic prostatic hypertrophy or bladder neck obstruction Narrow-angle glaucoma History of asthma, allergic rhinitis, atopic disease, or who have a total blood eosinophil count >= 600 mm3 History of life-threatening pulmonary obstruction, or cystic fibrosis or clinically evident bronchiectasis Active tuberculosis History of and/or active significant alcohol or drug abuse Underwent thoracotomy with pulmonary resection Completed a pulmonary rehabilitation program within the 6 weeks prior to the Scr. Visit or who are currently in a pulmonary rehabilitation program Regularly use daytime oxygen for more than 1 h/day and in the investigator?s opinion unable to abstain from the use of oxygen Took an investigational drug within 1 m or 6 half lives prior to Scr. Visit Beta-blockers Anti-allergic drugs or antihistamines for asthma, allergic rhinitis, atopic disease, or other allergic disease with a total blood eosinophil count >= 600 mm3 Oral corticosteroids at unstable doses or at doses in excess of the equivalent of 10 mg of prednisone/day or 20 mg every other day Hypersensitivity to anticholinergic drugs, or components of the Respimat delivery system, to lactose or any other component of the inhalation capsule deliver system Pregnant or suspect of pregnant or women who are willing to become pregnant during the study period or nursing women Who are currently participating in another study The randomisation of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Scr. Visit or during the scr. period should be postponed

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

The primary outcome is the trough FEV1 response determined at the end of each 4-week period of randomised treatment.

Secondary Outcome Measures

Trough FVC response after 4 weeks, peak response (FEV1 and FVC) to first dose, peak response (FEV1 and FVC) after 4 weeks, FEV1 AUC0-3h and FVC AUC0-3h response to first dose and after 4 weeks, individual FEV1and FVC measurements at each time point.

Full Information

First Posted
February 15, 2006
Last Updated
October 28, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00292448
Brief Title
A Randomised, Double-blind, Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Randomised, Double-blind, Double-dummy, Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Ba 679 BR Respimat® 5 μg and Tiotropium Inhalation Capsule 18 μg in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The objective of this trial is to compare the efficacy and the safety of Ba 679 BR Respimat 5 ug once daily to tiotropium inhalation capsule 18 ug (Spiriva inhalation capsule) in a crossover study of 4-week treatment periods in patients with COPD.
Detailed Description
This is a 16-week, multi-centre, randomised, double-blind, double-dummy, crossover study of 4-week randomised treatment periods to demonstrate the efficacy and safety of 5 ug of Ba 679 BR inhalation solution from Respimat compared to tiotropium inhalation powder capsule (18 ug) via HandiHaler in patients with COPD. The two 4-week randomised treatment periods are separated by 4-week washout period. Study Hypothesis: The primary aim of this trial is to demonstrate non-inferiority of lung function response to 5 ug (2 actuations of 2.5 ug) of Ba679BR Respimat delivered by the Respimat inhaler once daily compared to tiotropium (18 ug) inhaled as powder capsule from the HandiHaler once daily at the end of 4-week treatment periods in patients with COPD. The hypothesis test of non-inferiority will be performed at alpha = 0.025 (one-sided). Comparison(s): The primary efficacy endpoint is the trough FEV1 response determined at the end of each 4-week period of randomised treatment.

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 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
157 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ba 679 BR Respimat
Intervention Type
Drug
Intervention Name(s)
Tiotropium (Spiriva) inhalation capsule 18 ug
Primary Outcome Measure Information:
Title
The primary outcome is the trough FEV1 response determined at the end of each 4-week period of randomised treatment.
Secondary Outcome Measure Information:
Title
Trough FVC response after 4 weeks, peak response (FEV1 and FVC) to first dose, peak response (FEV1 and FVC) after 4 weeks, FEV1 AUC0-3h and FVC AUC0-3h response to first dose and after 4 weeks, individual FEV1and FVC measurements at each time point.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
participation in the trial 2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: ? Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 =< 70% of predicted normal* and FEV1 =< 70% of FVC (Visits 1 and 2). *: Predicted normal values will be calculated according to the formulas for Japanese predicted normal values (R05-0607) (see below). Males: FEV1 predicted (L) = 0.036 x (height (cm)) ? 0.028 x age (years) ? 1.178 Females: FEV1 predicted (L) = 0.022 x (height (cm)) ? 0.022 x age (years) ? 0.005 ? Patients must maintain stable COPD medications for 1 month prior to Visit 1. 3. Male or female patients 40 years of age or older. 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Pack Years = [Number of cigarettes/ day / 20] x years of smoking 5. Patients must be able to perform technically acceptable pulmonary function tests. 6. Patients must be able to inhale medication in a competent manner from the Respimat inhaler and the HandiHaler. Patients with/who: Significant diseases except COPD Clinically relevant abnormal haematology, blood chemistry, or urinalysis Recent history of MI Any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past 3 yrs Cancer within the last 5 yrs Symptomatic prostatic hypertrophy or bladder neck obstruction Narrow-angle glaucoma History of asthma, allergic rhinitis, atopic disease, or who have a total blood eosinophil count >= 600 mm3 History of life-threatening pulmonary obstruction, or cystic fibrosis or clinically evident bronchiectasis Active tuberculosis History of and/or active significant alcohol or drug abuse Underwent thoracotomy with pulmonary resection Completed a pulmonary rehabilitation program within the 6 weeks prior to the Scr. Visit or who are currently in a pulmonary rehabilitation program Regularly use daytime oxygen for more than 1 h/day and in the investigator?s opinion unable to abstain from the use of oxygen Took an investigational drug within 1 m or 6 half lives prior to Scr. Visit Beta-blockers Anti-allergic drugs or antihistamines for asthma, allergic rhinitis, atopic disease, or other allergic disease with a total blood eosinophil count >= 600 mm3 Oral corticosteroids at unstable doses or at doses in excess of the equivalent of 10 mg of prednisone/day or 20 mg every other day Hypersensitivity to anticholinergic drugs, or components of the Respimat delivery system, to lactose or any other component of the inhalation capsule deliver system Pregnant or suspect of pregnant or women who are willing to become pregnant during the study period or nursing women Who are currently participating in another study The randomisation of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Scr. Visit or during the scr. period should be postponed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Nippon Boehringer Ingelheim Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Akita, Akita
ZIP/Postal Code
010-1495
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Bunkyo-ku, Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Bunkyo-ku,Tokyo
ZIP/Postal Code
113-0022
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Habikino, Osaka
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Inashiki-gun, Ibaraki
ZIP/Postal Code
300-0395
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Itami, Hyogo
ZIP/Postal Code
664-8540
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kamogawa, Chiba
ZIP/Postal Code
296-0041
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kishiwada, Osaka
ZIP/Postal Code
596-8501
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Komaki, Aichi
ZIP/Postal Code
485-0044
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kurume, Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Kyoto, Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Matsumoto, Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Morioka, Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Osakasayama, Osaka
ZIP/Postal Code
589-0014
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sakai, Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sendai, Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sendai, Miyagi
ZIP/Postal Code
981-8563
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Sendai, Miyagi
ZIP/Postal Code
984-8560
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Seto, Aichi
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Shinjuku-ku, Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Takatsuki, Osaka
ZIP/Postal Code
569-1096
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Toyonaka, Osaka
ZIP/Postal Code
560-8552
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Tsukuba, Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Wakayama, Wakayama
ZIP/Postal Code
641-0012
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Yokohama, Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Boehringer Ingelheim Investigational Site
City
Yokote, Akita
ZIP/Postal Code
013-8610
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.291_U07-3262.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.291_literature.pdf
Description
Related Info

Learn more about this trial

A Randomised, Double-blind, Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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