A Study of the Safety and Efficacy of 4 Doses of BI 1744 CL Delivered Via the Respimat in Patients With Asthma.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01013753
First received: November 13, 2009
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

The primary objective of this study is to determine the efficacy and safety of 4 doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma in comparison to placebo.


Condition Intervention Phase
Asthma
Drug: Placebo
Drug: Olodaterol (BI 1744) high
Drug: Olodaterol (BI 1744) medium
Drug: Olodaterol (BI 1744) very low
Drug: Formoterol 12 mcg
Drug: Olodaterol (BI 1744) low
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: A Randomised, Double-Blind, Placebo- and Active-Controlled, Incomplete Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Once Daily Treatment of 4 Doses of BI 1744 CL Inhalation Solution Delivered by the Respimat® in Patients With Asthma

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • FEV1 (Forced expiratory volume in 1 second) AUC 0 to 24 (Area under the curve 0 to 24 hours) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1, FVC and PEF peak, trough and AUC 0-24 measured after the first two weeks of randomised period ; PEF variability [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • rescue medication use; AQLQ; ACQ. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • FEV1 am/pm pre dose measured at home; weekly mean No of night awakenings; asthma symptoms and QoL by assessed by patient's e-diary; asthma symptoms free days all obtained after the first 2 weeks of each randomised treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration 20', 1H and 3H after dosing at steady state [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • All adverse events; Vital signs - Pulse rate and Blood pressure pre dose and up to 3H post dose; Routine blood chemistry, haematology and urineanalysis and ECGs pre dose and up to 3H post dose [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Peak expiratory flow (PEF) am / pm; FEV1 (AUC0 to 12h) and FEV1 (AUC12 to 24) ; peak FEV1; Trough FEV1; Trough FVC; FVC (AUC0 to 12h) and FVC (AUC12 to 24) and peak FVC [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 198
Study Start Date: February 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olodaterol (BI 1744) low
Low dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744) low
Determine efficacy and safety of 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
Experimental: Olodaterol (BI 1744) very low
Very low dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744) very low
Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
Experimental: Olodaterol (BI 1744) medium
Medium dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744) medium
Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
Experimental: Olodaterol (BI 1744) high
High dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744) high
Determine efficacy and safety in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
Active Comparator: Formoterol 12 mcg
12mcg inhaled twice daily from the Aerolizer inhaler
Drug: Formoterol 12 mcg
Determine efficacy and safety of 12 mcg Formoterol dose inhaled orally twice daily from the Aerolizer in comparison to other treatment groups
Placebo Comparator: Placebo
Olodaterol (BI 1744) placebo inhaled once daily from the Repimat inhaler and/or Formoterol placebo inhaled twice daily from the Aerolizer inhaler
Drug: Placebo
Determine efficacy and safety of Placebo inhaled once daily from the Respimat inhaler and/or twice daily from the Aerolizer inhaler

  Eligibility

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

Inclusion criteria:

  1. All patients must sign an informed consent consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, i.e. prior to any study procedures which includes medication washout and restrictions. A separate informed consent is required for pharmacogenomic sampling.
  2. Male or female patients, aged between 18 and 70 years of age, diurnally active
  3. A history of asthma diagnosed by physician at least 3 months prior to Visit 1 at GINA treatment steps 3 or 4. The diagnosis of asthma must have been made before the age of 40.
  4. Pre-bronchodilator FEV1 between 60% predicted and 90% predicted at Visit 1.
  5. Increase in FEV1 greater or equal to 12% and 200 ml 15 minutes after 400mcg salbutamol (albuterol) at Visit 1.
  6. Patient must have been taking inhaled corticosteroids (ICS) for at least 12 weeks prior to screening, and must have been receiving at a stable dose for at least 6 weeks prior to screening either: - a medium to high dose ICS or - a low to high dose ICS in combination with Long acting beta agonist (LABA).
  7. All patients must be symptomatic.

Exclusion criteria:

  1. Patients with a significant disease other than asthma; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study
  2. Patients who have been hospitalised for an asthma exacerbation within 3 months or had an admission to an intensive care unit for asthma within 3 years of Visit 1
  3. Patients will be excluded when they have: - an aspartate aminotransferase (AST) >80 IU/L, alanine aminotransferase (ALT) >80 IU/L, bilirubin >1.5 X upper limit of normal (ULN) or creatinine >1.5 X ULN - clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis
  4. Patients with any of the following conditions: - a diagnosis of thyrotoxicosis

    • a diagnosis of paroxysmal tachycardia (>100 beats per minute)
    • a marked baseline prolongation of QT/QTc interval at Visit 1 (e.g., repeated demonstration of a QTc interval >450 ms) as recommended by ICH E14
    • a history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) as recommended by ICH E14.
  5. Patients with any of the following conditions: - a history of myocardial infarction within 1 year of screening visit (Visit 1)

    • a diagnosis of clinically relevant cardiac arrhythmia
    • a history of cor pulmonale
    • known active tuberculosis
    • a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed)
    • a history of life-threatening pulmonary obstruction
    • a history of chronic obstructive pulmonary disease
    • history of cystic fibrosis
    • clinically evident bronchiectasis
    • a history of significant alcohol or drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013753

Locations
Austria
1222.27.43002 Boehringer Ingelheim Investigational Site
Linz, Austria
1222.27.43004 Boehringer Ingelheim Investigational Site
Schlüsslberg, Austria
1222.27.43001 Boehringer Ingelheim Investigational Site
Thalheim bei Wels, Austria
1222.27.43003 Boehringer Ingelheim Investigational Site
Wien, Austria
Germany
1222.27.49009 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.27.49003 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.27.49004 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.27.49011 Boehringer Ingelheim Investigational Site
Frankfurt, Germany
1222.27.49008 Boehringer Ingelheim Investigational Site
Hannover, Germany
1222.27.49002 Boehringer Ingelheim Investigational Site
Lübeck, Germany
1222.27.49007 Boehringer Ingelheim Investigational Site
Rüdersdorf, Germany
1222.27.49006 Boehringer Ingelheim Investigational Site
Wiesbaden, Germany
1222.27.49010 Boehringer Ingelheim Investigational Site
Wiesloch, Germany
Poland
1222.27.48002 Boehringer Ingelheim Investigational Site
Lodz, Poland
1222.27.48001 Boehringer Ingelheim Investigational Site
Lodz, Poland
1222.27.48003 Boehringer Ingelheim Investigational Site
Poznan, Poland
1222.27.48004 Boehringer Ingelheim Investigational Site
Proszowice, Poland
Romania
1222.27.40003 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1222.27.40002 Boehringer Ingelheim Investigational Site
Bucharest, Romania
Slovakia
1222.27.42101 Boehringer Ingelheim Investigational Site
Bardejov, Slovakia
1222.27.42103 Boehringer Ingelheim Investigational Site
Lucenec, Slovakia
1222.27.42104 Boehringer Ingelheim Investigational Site
Martin, Slovakia
1222.27.42102 Boehringer Ingelheim Investigational Site
Spisska Nova Ves, Slovakia
Slovenia
1222.27.38601 Boehringer Ingelheim Investigational Site
Golnik, Slovenia
1222.27.38603 Boehringer Ingelheim Investigational Site
Hoce, Slovenia
1222.27.38605 Boehringer Ingelheim Investigational Site
Kamnik, Slovenia
1222.27.38604 Boehringer Ingelheim Investigational Site
Topolsica, Slovenia
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01013753     History of Changes
Other Study ID Numbers: 1222.27, 2009-013395-48
Study First Received: November 13, 2009
Last Updated: November 30, 2012
Health Authority: Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
Poland: Registration Medicinal Product Medical Device Biocidal Product
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014