Olodaterol Bridging Study in Asthma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01428622 |
Recruitment Status :
Withdrawn
First Posted : September 5, 2011
Last Update Posted : November 22, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Device: Respimat Drug: Olodaterol Drug: Olodaterol & BI54903 Drug: BI54903 | Phase 2 |
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 |

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 |
- FEV1 (AUC0-12h) FEV1 = Forced expiratory volume in one second, AUC = area under the curve [ Time Frame: 12 hours ]
- FEV1 (AUC0-24h) [ Time Frame: 24 hours ]
- FEV1 (AUC12-24h) [ Time Frame: 12 hours ]
- Peak FEV1 [ Time Frame: 12 hours ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428622
France | |
1249.7.33003 Boehringer Ingelheim Investigational Site | |
Gières, France |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT01428622 |
Other Study ID Numbers: |
1249.7 2011-000935-98 ( EudraCT Number: EudraCT ) |
First Posted: | September 5, 2011 Key Record Dates |
Last Update Posted: | November 22, 2011 |
Last Verified: | November 2011 |
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 |