Olodaterol Bridging Study in Asthma - Full Text View

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:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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:

Informed Consent Form consistent guidelines and local legislation prior
Male or female patients aged at least 18 to 75 years.
Diagnosis of asthma according to the 2009 Global Initiative for Asthma (GINA) Guidelines.
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.
Asthma control questionaire (ACQ)-6 mean score of < 1.5.
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.
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.
Be able to use the inhalers correctly in the opinion of the investigator.
Be able to perform all trial related procedures.

Exclusion criteria:

Significant disease other than asthma.
Recent history (i.e. six months or less) of myocardial infarction.
Hospitalisation for cardiac failure during the past year.
Unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
Lung diseases other than asthma (e.g. Chronic obstructive pulmonary disease).
Active tuberculosis.
Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
Thoracotomy with pulmonary resection.
Alcohol or drug abuse within the past two years.
Pulmonary rehabilitation program
Hypersensitivity to LABA drugs, ciclesonide, salmeterol or any other components of the study medication delivery systems.
Pregnant or nursing woman.
Women of childbearing potential not using a highly effective method of birth control.

Contacts and Locations

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 Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
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 June 17, 2013