Olodaterol Bridging Study in Asthma

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01428622
First received: August 25, 2011
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

The aim of the study is to establish the olodaterol dose in the ethanolic fixed dose combination (FDC) with BI 54903 which is equivalent in bronchodilator effect and systemic exposure to the 5 µg olodaterol reference dose in the aqueous inhalation solution (AIS).


Condition Intervention Phase
Asthma
Device: Respimat
Drug: Olodaterol
Drug: Olodaterol & BI54903
Drug: BI54903
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: Single Dose Comparison of 3 Doses of Olodaterol in Double Fixed Dose Combination With BI54903 vs. 3 Doses of Olodaterol Mono in Free Combination

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • FEV1 (AUC0-12h) FEV1 = Forced expiratory volume in one second, AUC = area under the curve [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1 (AUC0-24h) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • FEV1 (AUC12-24h) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Peak FEV1 [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2011
Arms Assigned Interventions
Placebo Comparator: Placebo + BI 54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution
Experimental: Olodaterol low dose + BI54903
patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution
Active Comparator: Olodaterol medium dose + BI54903
patient to receive 2 puffs of each device
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution
Experimental: Olodaterol high dose + BI54903
patient to receive 2 puffs of each device
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution
Experimental: Olodaterol l dose + BI54903
patient to receive 2 puffs of each device
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution
Experimental: Olodaterol m dose + BI54903
patient to receive 2 puffs of each device
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution
Experimental: Olodaterol h dose + BI54903
patient to receive 2 puffs of each device
Device: Respimat
aqueous and ethanolic solution
Drug: Olodaterol
aqueous solution
Drug: Olodaterol & BI54903
ethanolic solution
Drug: BI54903
ethanolic solution

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Informed Consent Form consistent guidelines and local legislation prior
  2. Male or female patients aged at least 18 to 75 years.
  3. Diagnosis of asthma according to the 2009 Global Initiative for Asthma (GINA) Guidelines.
  4. Maintenance treatment with a low or medium dose of inhaled corticosteroids (ICS) with or without Long-acting beta-adrenergic (LABA), stable dose of inhaled corticosteroids (alone or in a fixed combination with a LABA) for at least for 6 weeks prior to screening.
  5. Asthma control questionaire (ACQ)-6 mean score of < 1.5.
  6. a. Pre-bronchodilator clinic measured FEV1 =50% and =90% of predicted normal b. FEV1 reversibility: Improvement in FEV1 =12% above baseline and an absolute change of at least 200 ml within 15-30 minutes after administration of 400 µg salbutamol.
  7. Never-smokers or ex-smokers with a smoking history of less than 10 pack-years and smoking cessation at least one year prior to screening.
  8. Be able to use the inhalers correctly in the opinion of the investigator.
  9. Be able to perform all trial related procedures.

Exclusion criteria:

  1. Significant disease other than asthma.
  2. Recent history (i.e. six months or less) of myocardial infarction.
  3. Hospitalisation for cardiac failure during the past year.
  4. Unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
  5. Lung diseases other than asthma (e.g. Chronic obstructive pulmonary disease).
  6. Active tuberculosis.
  7. Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
  8. Thoracotomy with pulmonary resection.
  9. Alcohol or drug abuse within the past two years.
  10. Pulmonary rehabilitation program
  11. Hypersensitivity to LABA drugs, ciclesonide, salmeterol or any other components of the study medication delivery systems.
  12. Pregnant or nursing woman.
  13. 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: NCT01428622

Locations
France
1249.7.33003 Boehringer Ingelheim Investigational Site
Gières, France
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01428622     History of Changes
Other Study ID Numbers: 1249.7, 2011-000935-98
Study First Received: August 25, 2011
Last Updated: November 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

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 22, 2014