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Olodaterol Bridging Study in Asthma

NCT ID: NCT01428622

Last Updated: 2011-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Placebo + BI 54903

patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"

Group Type PLACEBO_COMPARATOR

Respimat

Intervention Type DEVICE

aqueous and ethanolic solution

Olodaterol

Intervention Type DRUG

aqueous solution

Olodaterol & BI54903

Intervention Type DRUG

ethanolic solution

BI54903

Intervention Type DRUG

ethanolic solution

Olodaterol low dose + BI54903

patient to receive 2 puffs of respimat "A" and 2 puffs of respimat "B"

Group Type EXPERIMENTAL

Respimat

Intervention Type DEVICE

aqueous and ethanolic solution

Olodaterol

Intervention Type DRUG

aqueous solution

Olodaterol & BI54903

Intervention Type DRUG

ethanolic solution

BI54903

Intervention Type DRUG

ethanolic solution

Olodaterol medium dose + BI54903

patient to receive 2 puffs of each device

Group Type ACTIVE_COMPARATOR

Respimat

Intervention Type DEVICE

aqueous and ethanolic solution

Olodaterol

Intervention Type DRUG

aqueous solution

Olodaterol & BI54903

Intervention Type DRUG

ethanolic solution

BI54903

Intervention Type DRUG

ethanolic solution

Olodaterol high dose + BI54903

patient to receive 2 puffs of each device

Group Type EXPERIMENTAL

Respimat

Intervention Type DEVICE

aqueous and ethanolic solution

Olodaterol

Intervention Type DRUG

aqueous solution

Olodaterol & BI54903

Intervention Type DRUG

ethanolic solution

BI54903

Intervention Type DRUG

ethanolic solution

Olodaterol l dose + BI54903

patient to receive 2 puffs of each device

Group Type EXPERIMENTAL

Respimat

Intervention Type DEVICE

aqueous and ethanolic solution

Olodaterol

Intervention Type DRUG

aqueous solution

Olodaterol & BI54903

Intervention Type DRUG

ethanolic solution

BI54903

Intervention Type DRUG

ethanolic solution

Olodaterol m dose + BI54903

patient to receive 2 puffs of each device

Group Type EXPERIMENTAL

Respimat

Intervention Type DEVICE

aqueous and ethanolic solution

Olodaterol

Intervention Type DRUG

aqueous solution

Olodaterol & BI54903

Intervention Type DRUG

ethanolic solution

BI54903

Intervention Type DRUG

ethanolic solution

Olodaterol h dose + BI54903

patient to receive 2 puffs of each device

Group Type EXPERIMENTAL

Respimat

Intervention Type DEVICE

aqueous and ethanolic solution

Olodaterol

Intervention Type DRUG

aqueous solution

Olodaterol & BI54903

Intervention Type DRUG

ethanolic solution

BI54903

Intervention Type DRUG

ethanolic solution

Interventions

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Respimat

aqueous and ethanolic solution

Intervention Type DEVICE

Respimat

aqueous and ethanolic solution

Intervention Type DEVICE

Respimat

aqueous and ethanolic solution

Intervention Type DEVICE

Respimat

aqueous and ethanolic solution

Intervention Type DEVICE

Respimat

aqueous and ethanolic solution

Intervention Type DEVICE

Respimat

aqueous and ethanolic solution

Intervention Type DEVICE

Respimat

aqueous and ethanolic solution

Intervention Type DEVICE

Olodaterol

aqueous solution

Intervention Type DRUG

Olodaterol

aqueous solution

Intervention Type DRUG

Olodaterol

aqueous solution

Intervention Type DRUG

Olodaterol

aqueous solution

Intervention Type DRUG

Olodaterol

aqueous solution

Intervention Type DRUG

Olodaterol

aqueous solution

Intervention Type DRUG

Olodaterol

aqueous solution

Intervention Type DRUG

Olodaterol & BI54903

ethanolic solution

Intervention Type DRUG

Olodaterol & BI54903

ethanolic solution

Intervention Type DRUG

Olodaterol & BI54903

ethanolic solution

Intervention Type DRUG

Olodaterol & BI54903

ethanolic solution

Intervention Type DRUG

Olodaterol & BI54903

ethanolic solution

Intervention Type DRUG

Olodaterol & BI54903

ethanolic solution

Intervention Type DRUG

Olodaterol & BI54903

ethanolic solution

Intervention Type DRUG

BI54903

ethanolic solution

Intervention Type DRUG

BI54903

ethanolic solution

Intervention Type DRUG

BI54903

ethanolic solution

Intervention Type DRUG

BI54903

ethanolic solution

Intervention Type DRUG

BI54903

ethanolic solution

Intervention Type DRUG

BI54903

ethanolic solution

Intervention Type DRUG

BI54903

ethanolic solution

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1249.7.33003 Boehringer Ingelheim Investigational Site

Gières, , France

Site Status

Countries

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Bulgaria Canada Germany Romania Slovenia France

Other Identifiers

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2011-000935-98

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1249.7

Identifier Type: -

Identifier Source: org_study_id