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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01311661
First received: March 4, 2011
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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).


Condition Intervention Phase
Asthma
Drug: Olodaterol medium daily dose once daily and placebo
Drug: Olodaterol medium daily dose twice daily
Drug: Olodaterol low daily dose twice daily
Drug: Placebo twice daily
Drug: Olodaterol high daily dose once daily and placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase II, Randomised, Double-Blind, Cross-over Study to Compare the 24-hour FEV1-time Profile of Orally Inhaled Olodaterol, Delivered With the Respimat® Inhaler, After 3 Weeks of Olodaterol Once Daily Medium Dose, Twice Daily Low Dose and Placebo or After 3 Weeks of Once Daily High Dose, Twice Daily Medium Dose and Placebo Administration in Patients With Moderate to Severe Persistent Asthma

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Area under Curve after 24 hours (AUC 0-24 h) response after 3 weeks of treatment, calculated as Forced Expiratory Volume in 1 Second (FEV1) AUC 0-24 h minus the baseline FEV1. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean of daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Total ACQ score: Control of asthma as assessed by the Asthma Control Questionnaire (ACQ). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • All serious adverse events. Non-serious adverse events with an incidence of 5% or greater. [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]
  • Clinically relevant abnormalities for the following outcomes: vital signs, blood chemistry, haematology, urinalysis, ECG. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • FEV1 AUC 0-12 h response. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Highest number of night time awakenings as assessed by the patient's electronic diary. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Percentage of asthma symptom free days. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Worst day time asthma symptoms. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Worst night time asthma symptoms [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • PEF trough response. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • FVC AUC 0-24h response [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • FEV1 AUC 12-24 h response. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • FEV1 peak response (within 24 hours post-dose) measured following the morning trial-drug inhalation. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • FEV1 trough response (mean of the two FEV1values performed at 23:00 and 23:50 hours after the last morning trial-drug inhalation). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • FVC (Forced Vital Capacity) AUC 0-12h response. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • FVC AUC 12-24 h response. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • FVC peak response. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • FVC trough response. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • PEF (Peak Expiratory Flow) AUC 0-12 h response. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • PEF Area under Curve: AUC 12-24 h response. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • PEF Area under Curve: AUC 0-24 h response. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • PEF peak response. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Mean morning PEF (home measured). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Mean evening PEF (home measured). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • PEF (home measured) variability: the absolute difference between morning and evening PEF value divided by the mean of these two values. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Mean morning FEV1 (home measured). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Mean evening FEV1 (home measured). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 206
Study Start Date: March 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olodaterol medium daily dose
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 medium daily dose once daily and placebo
Inhaled Olodaterol medium daily dose administered as one full dose once daily and placebo once daily
Drug: Olodaterol low daily dose twice daily
Inhaled Olodaterol medium daily dose administered as low dose twice daily
Drug: Placebo twice daily
Inhaled Placebo of Olodaterol twice daily
Experimental: Olodaterol high daily dose
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: Olodaterol medium daily dose twice daily
Inhaled Olodaterol high daily dose administered as medium dose twice daily
Drug: Placebo twice daily
Inhaled Placebo of Olodaterol twice daily
Drug: Olodaterol high daily dose once daily and placebo
Inhaled Olodaterol high daily dose administered as one full dose once daily and placebo once daily

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01311661

  Show 36 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01311661     History of Changes
Other Study ID Numbers: 1222.29, 2008-006625-14
Study First Received: March 4, 2011
Last Updated: April 4, 2012
Health Authority: Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014