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Status:

COMPLETED

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

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Pulmonary Disease, Chronic Obstructive

Eligibility:

All Genders

40+ years

Phase:

PHASE2

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 ...

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 s...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 1 2006

    Trial Type :

    INTERVENTIONAL

    End Date :

    March 1 2007

    Estimated Enrollment :

    157 Patients enrolled

    Trial Details

    Trial ID

    NCT00292448

    Start Date

    February 1 2006

    End Date

    March 1 2007

    Last Update

    October 29 2013

    Active Locations (27)

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    Page 1 of 7 (27 locations)

    1

    Boehringer Ingelheim Investigational Site

    Akita, Akita, Japan, 010-1495

    2

    Boehringer Ingelheim Investigational Site

    Bunkyo-ku, Tokyo, Japan, 113-8431

    3

    Boehringer Ingelheim Investigational Site

    Bunkyo-ku,Tokyo, Japan, 113-0022

    4

    Boehringer Ingelheim Investigational Site

    Habikino, Osaka, Japan, 583-8588