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”

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.

Study Type: Interventional

Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: Tiotropium bromide
  • 5 mcg once daily
• Drug: Placebo
  • N/A
• Drug: Salmeterol xinafoate
  • 50 mcg twice daily

Primary 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 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
    

Inclusion 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 h istory 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:

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 infar ction
• 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 ye ar
• 5. Patients with malignancy for which the patient has undergone resection, radia tion therapy or chemotherapy within the last five years. Patients with treated b asal 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 histo ry 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 we eks 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00350207

Study ID Number: 205.342

ClinicalTrials.gov Identifier: NCT00350207

Health Authority: Slovakia: State Institute for Drug Control