Evaluation of tiotropium 2.5 and 5 mcg once daily delivered via the Respimat® inhaler compared to placebo and salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg twice daily) in patient with moderate persistent asthma II

• Conditions: Moderate persistent asthma; MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2009-018005-43-PL
• Lead Sponsor: Boehringer Ingelheim RCV GmbH&Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-03
• Last Update Posted: 4 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Outpatients of either sex, aged 18-75 years
Diagnosis of moderate persistent asthma.
Asthma diagnosis made before age of 40.
At least a 3 month history of asthma.
Pre-bronchodilator FEV1 = 60% and = 90% of predicted at Visit 1.
Increase in FEV1 of = 12% and = 200 mL 15 to 30 min after 400 µg
salbutamol (albuterol) at Visit 1.
Maintenance treatment with medium dose of inhaled corticosteroids for
at least 4 weeks before Visit 1.
Symptomatic despite their current maintenance treatment with ICS (ACQ
= 1.5).
Variation in absolute pre-BD FEV1 values Visit 1 compared to Visit 2
within ± 30%.
Never-smokers or ex-smokers (stopped at least one year prior to
enrolment + smoking history of less than 10 pack years).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Patients with a significant disease other than asthma.
Patients with a clinically relevant abnormal screening haematology or
blood chemistry if the abnormalitiy defines a significant disease.
Patients with a recent history (i.e. six months or less) of myocardial
infarction. Patients who have been hospitalised for cardiac failure during
the past year. Patients with any unstable or life-threatening cardiac
arrhythmia or cardiac arrhythmia requiring intervention or a change in
drug therapy within the past year.
Patients with lung diseases other than asthma (e.g. COPD).
Patients with known active tuberculosis.
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.
Patients who have undergone thoracotomy with pulmonary resection.
Patients with a history of thoracotomy for other reasons should be
evaluated as per exclusion criterion no. 1.
Patients with significant alcohol or drug abuse within the past two years.
Patients who are currently in a pulmonary rehabilitation program or
have completed a pulmonary rehabilitation program in the 6 weeks prior
to Visit 1 (screening).
Pregnant or nursing woman.
Women of childbearing potential not using a highly effective method of
birth control.
Patients with any asthma exacerbation or any respiratory tract infection
in the four weeks prior to Visit 1 or during the screening period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified