Olodaterol Bridging Study in Asthma

Single Dose Comparison of 3 Doses of Olodaterol in Double Fixed Dose Combination With BI54903 vs. 3 Doses of Olodaterol Mono in Free Combination

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).

Study Overview

• Status: Withdrawn
• Conditions: Asthma
• Intervention / Treatment: Device: Respimat; Drug: Olodaterol; Drug: Olodaterol & BI54903; Drug: BI54903

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Gières, France
    • 1249.7.33003 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

7

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FEV1 (AUC0-12h) FEV1 = Forced expiratory volume in one second, AUC = area under the curve	12 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
FEV1 (AUC0-24h)	24 hours
FEV1 (AUC12-24h)	12 hours
Peak FEV1	12 hours

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: October 1, 2011

Study Registration Dates

• First Submitted: August 25, 2011
• First Submitted That Met QC Criteria: August 29, 2011
• First Posted (ESTIMATE): September 5, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 22, 2011
• Last Update Submitted That Met QC Criteria: November 21, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Olodaterol
• Other Study ID Numbers: 1249.7; 2011-000935-98 (EUDRACT_NUMBER: EudraCT)