Olodaterol Bridging Study in Asthma

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01428622 History of Changes
Other Study ID Numbers:	1249.7; 2011-000935-98 ( EudraCT Number: EudraCT )
First Posted:	September 5, 2011
Last Update Posted:	November 22, 2011
Last Verified:	November 2011

Additional relevant MeSH terms:

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; Adrenergic beta-1 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action