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Olodaterol Bridging Study in Asthma

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ClinicalTrials.gov Identifier: NCT01428622
Recruitment Status : Withdrawn
First Posted : September 5, 2011
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Device: Respimat Drug: Olodaterol Drug: Olodaterol & BI54903 Drug: BI54903 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Olodaterol

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. FEV1 (AUC0-12h) FEV1 = Forced expiratory volume in one second, AUC = area under the curve [ Time Frame: 12 hours ]

Secondary Outcome Measures :
  1. FEV1 (AUC0-24h) [ Time Frame: 24 hours ]
  2. FEV1 (AUC12-24h) [ Time Frame: 12 hours ]
  3. Peak FEV1 [ Time Frame: 12 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428622


Locations
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France
1249.7.33003 Boehringer Ingelheim Investigational Site
Gières, France
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01428622    
Other Study ID Numbers: 1249.7
2011-000935-98 ( EudraCT Number: EudraCT )
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Olodaterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents