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Olodaterol Bridging Study in Asthma

Primary Purpose

Asthma

Status

Withdrawn

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Respimat

Olodaterol

Olodaterol & BI54903

BI54903

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

1249.7.33003 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Experimental

Active Comparator

Experimental

Arm Label

Placebo + BI 54903

Olodaterol low dose + BI54903

Olodaterol medium dose + BI54903

Olodaterol high dose + BI54903

Olodaterol l dose + BI54903

Olodaterol m dose + BI54903

Olodaterol h dose + BI54903

Arm Description

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

patient to receive 2 puffs of each device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

FEV1 (AUC0-24h)

FEV1 (AUC12-24h)

Peak FEV1

Full Information

NCT ID

NCT01428622

First Posted

August 25, 2011

Last Updated

November 21, 2011

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01428622

Brief Title

Olodaterol Bridging Study in Asthma

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 Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Withdrawn

Study Start Date

October 2011 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo + BI 54903

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Olodaterol low dose + BI54903

Arm Type

Experimental

Arm Description

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

Arm Title

Olodaterol medium dose + BI54903

Arm Type

Active Comparator

Arm Description

patient to receive 2 puffs of each device

Arm Title

Olodaterol high dose + BI54903

Arm Type

Experimental

Arm Description

patient to receive 2 puffs of each device

Arm Title

Olodaterol l dose + BI54903

Arm Type

Experimental

Arm Description

patient to receive 2 puffs of each device

Arm Title

Olodaterol m dose + BI54903

Arm Type

Experimental

Arm Description

patient to receive 2 puffs of each device

Arm Title

Olodaterol h dose + BI54903

Arm Type

Experimental

Arm Description

patient to receive 2 puffs of each device

Intervention Type

Device

Intervention Name(s)

Respimat

Intervention Description