Efficacy (Bronchoprotection) and Safety of Orally Inhaled BI 1744 CL in Patients With Intermittent Asthma

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00928668
First received: June 25, 2009
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

The primary objective of this study is to assess the efficacy (bronchoprotection) and safety of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the Respimat® inhaler, in patients with intermittent asthma.


Condition Intervention Phase
Asthma
Drug: Placebo
Drug: Olodaterol (BI1744CL)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomised, Double-Blind, Placebo-Controlled, 5-Way Cross-Over Study to Assess the Efficacy (Bronchoprotection) and Safety of a Single Dose of Orally Inhaled BI 1744 CL (2, 5, 10 and 20ug) in Patients With Intermittent Asthma

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours [ Time Frame: 24 hours post dose ] [ Designated as safety issue: No ]
    Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours


Secondary Outcome Measures:
  • Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes [ Time Frame: 30 minutes post dose ] [ Designated as safety issue: No ]
    Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes

  • Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours [ Time Frame: 4 hours post dose ] [ Designated as safety issue: No ]
    Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours

  • Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours [ Time Frame: 8 hours post dose ] [ Designated as safety issue: No ]
    Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours

  • Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours [ Time Frame: 32 hours post dose ] [ Designated as safety issue: No ]
    Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours

  • Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).

  • Laboratory Testing: Average Change From Baseline of Potassium and Calcium [ Time Frame: Baseline to Visit 6 ] [ Designated as safety issue: No ]
    Laboratory testing: Average change from baseline of potassium and calcium measured on test-days


Enrollment: 32
Study Start Date: January 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olodaterol (BI1744) Low
Single dosing of low dose Olodaterol inhaled orally from Respimat Device
Drug: Olodaterol (BI1744CL)
Olodaterol comparison of low, medium low, medium high and high doses
Experimental: Olodaterol (BI1744) Medium Low
Single dosing of medium low dose Olodaterol inhaled orally from Respimat Device
Drug: Olodaterol (BI1744CL)
Olodaterol comparison of low, medium low, medium high and high doses
Experimental: Olodaterol (BI1744) Medium High
Single dosing of medium high dose Olodaterol inhaled orally from Respimat Device
Drug: Olodaterol (BI1744CL)
Olodaterol comparison of low, medium low, medium high and high doses
Experimental: Olodaterol (BI 1744) High
Single dosing of high dose Olodaterol inhaled orally from Respimat Device
Drug: Olodaterol (BI1744CL)
Olodaterol comparison of low, medium low, medium high and high doses
Placebo Comparator: Placebo
Single dosing of Olodaterol placebo inhaled orally from Respimat Device
Drug: Placebo
Placebo device for comparison

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Diagnosis of intermittent asthma according to Global Initiative for Asthma criteria
  2. Non-smokers or ex-smokers who have not smoked for at least 1 year and have a smoking history of less than 5 pack-years
  3. Forced Expiratory Volume in 1second greater than or equal to 80% predicted normal (Visit 1).
  4. Bronchial hyperresponsiveness to inhaled methacholine with a provocative concentration of a methacholine causing a 20% fall in Forced Expiratory Volume in one second less than or equal to 8 mg/mL (Visit 1).
  5. Be able to perform technically acceptable pulmonary function tests
  6. Be able to inhale medication in a competent manner from the Respimat® inhaler
  7. Must sign and date an informed consent consistent with International Conference on Harmonisation-Good Clinical Practice guidelines prior to participation in the trial, which includes medication washout and restrictions.

Exclusion criteria

  1. Patients with a significant disease other than asthma
  2. Patients with seasonal asthma or allergies whose participation in the trial will occur during the season for which they are allergic.
  3. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with a serum glutamic oxaloacetic transaminase > 80 IU/L, serum glutamic pyruvic transaminase > 80 IU/L, bilirubin >2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition
  4. Patients with any of the following conditions: a diagnosis of hyperthyrosis or paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of QT/QTc interval, a history of additional risk factors for Torsade de Pointes, a history of myocardial infarction, a diagnosis of clinically relevant cardiac arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years (patients with treated basal cell carcinoma are allowed), a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, or a history of significant alcohol or drug abuse.
  5. Patients who have undergone thoracotomy with pulmonary resection
  6. Patients who are being treated with any of the following concomitant medications: medications that prolong the QT/QTc interval, oral beta-adrenergics, beta-blockers or monoamine oxidase inhibitors or tricyclic antidepressants.
  7. Patients who have been treated with any respiratory medications (excluding short-acting beta-agonists) for control of their asthma symptoms within 3 months of the Screening Visit (Visit 1).
  8. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1).
  9. Pregnant or nursing women, or women of childbearing potential not using a highly effective method of birth control.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928668

Locations
Canada, British Columbia
1222.4.103 UBC - Respiratory Medicine
Vancouver, British Columbia, Canada
Canada, Ontario
1222.4.104 Department of Medicine, Health Sciences Centre
Hamilton, Ontario, Canada
Canada, Quebec
1222.4.101 2725 Chemin Ste Foy
Sainte-Foy, Quebec, Canada
Canada, Saskatchewan
1222.4.102
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00928668     History of Changes
Other Study ID Numbers: 1222.4
Study First Received: June 25, 2009
Results First Received: March 28, 2014
Last Updated: May 29, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014