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

NCT01311661 | Completed Phase 2 Results

• 2 other identifiers: 1222.292008-006625-14
• Study Type: interventional
• Target: 206
• Locations: 5 countries
• Sites: 32

Brief Summary

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).

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period

  Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.

  1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks

Secondary Outcomes (26)

• FEV1 Area Under Curve 0-12 Hours (AUC 0-12h) Response at the End of Each Treatment Period

  1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min related to morning dose after 3 weeks

• FEV1 Area Under Curve 12-24 Hours (AUC 12-24h) Response at the End of Each Treatment Period

  1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks

• Peak FEV1 Within 24 Hours Post-dose Response

  1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks

• Trough FEV1 Response

  1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks

• Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response

  1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min related to morning dose after 3 weeks

Study Arms (2)

Olodaterol medium daily dose

EXPERIMENTAL

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

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

Olodaterol high daily dose

EXPERIMENTAL

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

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

Interventions

Placebo twice daily DRUG

Inhaled Placebo of Olodaterol twice daily

Olodaterol high daily dose

Olodaterol low daily dose twice daily DRUG

Inhaled Olodaterol medium daily dose administered as low dose twice daily

Olodaterol medium daily dose

Olodaterol medium daily dose twice daily DRUG

Inhaled Olodaterol high daily dose administered as medium dose twice daily

Olodaterol high daily dose

Olodaterol high daily dose once daily and placebo DRUG

Inhaled Olodaterol high daily dose administered as one full dose once daily and placebo once daily

Olodaterol high daily dose

Olodaterol medium daily dose once daily and placebo DRUG

Inhaled Olodaterol medium daily dose administered as one full dose once daily and placebo once daily

Olodaterol medium daily dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (36)

1222.29.11006 Boehringer Ingelheim Investigational Site

Huntington Beach, California, United States

Location

1222.29.11001 Boehringer Ingelheim Investigational Site

Centennial, Colorado, United States

Location

1222.29.11012 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

1222.29.11002 Boehringer Ingelheim Investigational Site

Overland Park, Kansas, United States

Location

1222.29.11004 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1222.29.11011 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1222.29.11009 Boehringer Ingelheim Investigational Site

Skillman, New Jersey, United States

Location

1222.29.11003 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

1222.29.11008 Boehringer Ingelheim Investigational Site

Canton, Ohio, United States

Location

1222.29.11007 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1222.29.11005 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

1222.29.11010 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1222.29.43003 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

1222.29.43002 Boehringer Ingelheim Investigational Site

Schlüsslberg, Austria

Location

1222.29.43001 Boehringer Ingelheim Investigational Site

Thalheim bei Wels, Austria

Location

1222.29.43004 Boehringer Ingelheim Investigational Site

Wels, Austria

Location

1222.29.49004 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.29.49006 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.29.49007 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.29.49008 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.29.49002 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1222.29.49010 Boehringer Ingelheim Investigational Site

Großhansdorf, Germany

Location

1222.29.49003 Boehringer Ingelheim Investigational Site

Lübeck, Germany

Location

1222.29.49005 Boehringer Ingelheim Investigational Site

Rüdersdorf, Germany

Location

1222.29.49001 Boehringer Ingelheim Investigational Site

Wiesbaden, Germany

Location

1222.29.49009 Boehringer Ingelheim Investigational Site

Wiesloch, Germany

Location

1222.29.36002 Boehringer Ingelheim Investigational Site

Mosonmagyaróvár, Hungary

Location

1222.29.36003 Boehringer Ingelheim Investigational Site

Nyíregyháza, Hungary

Location

1222.29.36001 Boehringer Ingelheim Investigational Site

Sopron, Hungary

Location

1222.29.36004 Boehringer Ingelheim Investigational Site

Zalaegerszeg, Hungary

Location

1222.29.42001 Boehringer Ingelheim Investigational Site

Bardejov, Slovakia

Location

1222.29.42002 Boehringer Ingelheim Investigational Site

Martin, Slovakia

Location

1222.29.42004 Boehringer Ingelheim Investigational Site

Nitra, Slovakia

Location

1222.29.42003 Boehringer Ingelheim Investigational Site

Spišská Nová Ves, Slovakia

Location

1222.29.38003 Boehringer Ingelheim Investigational Site

Golnik, Slovenia

Location

1222.29.38002 Boehringer Ingelheim Investigational Site

Kamnik, Slovenia

Location

Related Publications (1)

• Beeh KM, LaForce C, Gahlemann M, Wenz A, Toorawa R, Flezar M. Randomised, double-blind, placebo-controlled crossover study to investigate different dosing regimens of olodaterol delivered via Respimat(R) in patients with moderate to severe persistent asthma. Respir Res. 2015 Jul 16;16(1):87. doi: 10.1186/s12931-015-0243-1.

  PMID: 26177937 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 9, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2011
• Last Updated: May 1, 2014
• Results First Posted: May 1, 2014

Record last verified: 2014-03

Locations

DE (10); AU (4); HU (4); SL (2); US (12)