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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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).

Key facts

Study ID

NCT01311661

Run by

Boehringer Ingelheim

People needed

206

Starts

2011-03-01

Last updated by the study team

2014-05-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients of either sex.
• Aged 18 to 70 years.
• A current diagnosis and a documented minimum 3 month history of asthma Global Initiative for Asthma (GINA) treatment steps 3 and 4.
• Prebronchodilator Forced Expiratory Volume in one second (FEV1) >= 60% predicted and < 90% predicted according to European Coal and Steel Community (ECSC).
• Increase in FEV1 >=12% and >=200 mL 15 min. after 400 µg salbutamol (albuterol);
• 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.

You may not qualify if…

• Patients with a significant disease other than asthma.
• History of frequent seasonal exacerbations of asthma (defined as one or more seasonal exacerbations every year for the past three years).
• Upper respiratory tract infection in the past 3 weeks prior to screening visit 1b.
• Oral or other systemic corticosteroids in the past 6 weeks.
• 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.

Where it is running

• 1222.29.11006 Boehringer Ingelheim Investigational Site — Huntington Beach, California, United States
• 1222.29.11001 Boehringer Ingelheim Investigational Site — Centennial, Colorado, United States
• 1222.29.11012 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
• 1222.29.11002 Boehringer Ingelheim Investigational Site — Overland Park, Kansas, United States
• 1222.29.11004 Boehringer Ingelheim Investigational Site — North Dartmouth, Massachusetts, United States
• 1222.29.11011 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
• 1222.29.11009 Boehringer Ingelheim Investigational Site — Skillman, New Jersey, United States
• 1222.29.11003 Boehringer Ingelheim Investigational Site — Raleigh, North Carolina, United States
• 1222.29.11008 Boehringer Ingelheim Investigational Site — Canton, Ohio, United States
• 1222.29.11007 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
• 1222.29.11005 Boehringer Ingelheim Investigational Site — Spartanburg, South Carolina, United States
• 1222.29.11010 Boehringer Ingelheim Investigational Site — Richmond, Virginia, United States
• 1222.29.43003 Boehringer Ingelheim Investigational Site — Linz, Austria
• 1222.29.43002 Boehringer Ingelheim Investigational Site — Schlüsslberg, Austria
• 1222.29.43001 Boehringer Ingelheim Investigational Site — Thalheim bei Wels, Austria
• 1222.29.43004 Boehringer Ingelheim Investigational Site — Wels, Austria
• 1222.29.49004 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1222.29.49006 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1222.29.49007 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1222.29.49008 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1222.29.49002 Boehringer Ingelheim Investigational Site — Frankfurt, Germany
• 1222.29.49010 Boehringer Ingelheim Investigational Site — Großhansdorf, Germany
• 1222.29.49003 Boehringer Ingelheim Investigational Site — Lübeck, Germany
• 1222.29.49005 Boehringer Ingelheim Investigational Site — Rüdersdorf, Germany
• 1222.29.49001 Boehringer Ingelheim Investigational Site — Wiesbaden, Germany

Full record on ClinicalTrials.gov

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