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Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00350207
  Purpose

This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-contro lled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to s almeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16t h amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in pe riod on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmetero l twice daily administered from the HFA-MDI, or placebo twice daily. After the 16 week treatment per iod all patients will receive salmeterol MDI twice daily for four weeks. The patients perform daily morning and evening peak flow and FEV1 measurements with an electronic pe ak flow meter throughout the study. Daily data on asthma control and use of rescue medication are re corded using an electronic diary included in the electronic peak flow meter. On study visits the Min i-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and FVC) are performed.


Condition Intervention Phase
Asthma
Drug: Tiotropium bromide
Drug: Placebo
Drug: Salmeterol xinafoate
Phase II

MedlinePlus related topics: Asthma
Drug Information available for: Tiotropium Tiotropium bromide Salmeterol Salmeterol xinafoate HFA 227
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A 16-Week Randomised, Placebo-Controlled, Double-Blind, Double-Dummy, Parallel-Group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint of this study is the change in mean weekly morning peak expiratory flow from baseline to the last week of treatment. Baseline is defined as the last week prior to randomisation visit. [ Time Frame: Change from baseline after 16 weeks of treatment ]

Secondary Outcome Measures:
  • Daily morning and evening peak expiratory flow and FEV1 Daily diary on asthma control Morning pre dose FEV1 and morning pre dose FVC on study visits Mini Asthma Quality of Life Questionnaire on study visits Vital Signs Adverse events [ Time Frame: Change from baseline after 16 weeks of treatment ]

Enrollment: 388
Study Start Date: July 2006
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients homozygous for arginine at the 16th amino acid position of the beta2 adrenergic receptor (B16 Arg/Arg)
  2. All patients must sign and date an Informed Consent Form for the study prior to participation in the trial
  3. Male or female outpatients with at least 18 years of age, but not older than 65 years
  4. Patients must have a documented history of asthma
  5. Patients must be current non-smokers or ex-smokers with a cigarette smoking history of <10 pack-years
  6. Patients must be on a maintenance treatment with inhaled corticosteroids with a total daily dose of 400 - 1000 mcg budesonide or equivalent

Exclusion Criteria:

  1. Patients with a significant disease other than asthma
  2. Patients with a recent history (i.e., six months or less) of myocardial infarction
  3. Patients who have been hospitalized for heart failure (NYHA class III or IV) within the past year
  4. Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
  5. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
  6. Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
  7. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
  8. Patients with known active tuberculosis
  9. Patients who have undergone thoracotomy with pulmonary resection.
  10. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to visit 1 or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350207

  Show 121 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 205.342
Study First Received: July 7, 2006
Last Updated: October 1, 2008
ClinicalTrials.gov Identifier: NCT00350207  
Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation;   Slovakia: State Institute for Drug Control;   Austria: Federal Office for Safety in Health Care;   Belgium: Federal Agency for Medicines and Health Products;   Denmark: Danish Medicines Agency;   Germany: Federal Institute for Drugs and Medical Devices;   Spain: Spanish Medicines and Healthcare Products Agency;   France: French Health Products Safety Agency (AFSSAPS);   Greece: EOF-National Organisation for Medicines;   Italy: Committee for the clinical experimentation of drug - Company Hospital University Pisana;   Finland: National Agency for Medicines;   Turkey: Ministry of Health Central Ethics Committee;   Great Britain: MHRA;   South Africa: Medicines Control Council

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Salmeterol
Respiratory Tract Diseases
Bromides
Lung Diseases
Hypersensitivity, Immediate
Asthma
Tiotropium
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Adrenergic Agents
Adrenergic beta-Agonists
Bronchial Diseases
Immune System Diseases
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009