A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Olodaterol low daily dose twice daily; Drug: Olodaterol medium daily dose once daily and placebo; Drug: Olodaterol high daily dose once daily and placebo; Drug: Olodaterol medium daily dose twice daily; Drug: Placebo twice daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT01311661

2008-006625-14 (EudraCT Number)

1222.29

Details and patient eligibility

About

This study will compare efficacy and safety of different regimens of olodaterol administration in asthma (once daily, twice daily) with placebo in a complete cross-over design each within one of the two daily dose groups (medium or high daily dose).

Enrollment: 206 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients of either sex.
2. Aged 18 to 70 years.
3. A current diagnosis and a documented minimum 3 month history of asthma Global Initiative for Asthma (GINA) treatment steps 3 and 4.
4. Prebronchodilator Forced Expiratory Volume in one second (FEV1) >= 60% predicted and < 90% predicted according to European Coal and Steel Community (ECSC).
5. Increase in FEV1 >=12% and >=200 mL 15 min. after 400 µg salbutamol (albuterol);
6. Stable on medium to high dose inhaled corticosteroids (ICS) or low to high dose ICS in combination with a long acting beta-adrenergics (LABA) for at least 6 weeks prior to screening. Stable on ICS mono component of the former fixed LABA/ICS treatment for at least 48 hours prior to Visit 1b.

Exclusion criteria

1. Patients with a significant disease other than asthma.
2. History of frequent seasonal exacerbations of asthma (defined as one or more seasonal exacerbations every year for the past three years).
3. Upper respiratory tract infection in the past 3 weeks prior to screening visit 1b.
4. Oral or other systemic corticosteroids in the past 6 weeks.
5. Patients with allergen desensitization therapy if started within two years, if they are not on an established maintenance regimen characterized by dose adjustments but no further increase to the tolerable maximum in the same course of immunotherapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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206 participants in 2 patient groups

Olodaterol medium daily dose

Experimental group

Description:

Olodaterol medium daily dose given either as once daily or split into two low doses daily or placebo only in randomised sequence of three cross-over treatment phases

Treatment:

Drug: Placebo twice daily

Drug: Olodaterol low daily dose twice daily

Drug: Olodaterol medium daily dose once daily and placebo

Drug: Placebo twice daily

Olodaterol high daily dose

Experimental group

Description:

Olodaterol high daily dose given either as once daily or split into two medium doses daily or placebo only in randomised sequence of three cross-over treatment phases

Treatment:

Drug: Placebo twice daily

Drug: Olodaterol medium daily dose twice daily

Drug: Olodaterol high daily dose once daily and placebo

Drug: Placebo twice daily