bronchodilatory effects of of Tiotropium combined with BI54903 (inhaled corticosteroid) with ethanolic inhalation solution via Respimat® compared to free combination of tiotropium with aqueous inhalation solution via Respimat® anf BI54903 ethanolic inhalation solution via Respimat® in patient with asthma.

Phase 1

• Conditions: Asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-001801-29-SK
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-13
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•Outpatients of either sex, aged 18-75 years (inclusive).
•Never-smokers or ex-smokers (for at least 1 year) with a smoking history of < 10 pack-years.
•Diagnosis of stable asthma on low-dose or medium-dose inhaled corticosteroids (ICS) with or without long-acting ß2-adrenergic agonists (LABA), GINA treatment steps 2-4.
•A pre-bronchodilator FEV1 = 50 – 90% predicted.
•Asthma Control Questionnaire-6 (ACQ-6) < 1.5
•FEV1 reversibility of = 12% above baseline and an absolute change of = 200 ml within 30 minutes after administration of 400 µg of salbutamol MDI (100 µg per puff).
•FEV1 reversibility (= 12% above baseline and an absolute change of = 200 ml) within 45 minutes after administration of 80 µg of ipratropium bromide MDI (20 µg per puff).

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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

-Patients with a recent history (i.e. six months or less) of myocardial infarction.
-Patients requiring more than 8 puffs of salbutamol MDI on at least 2 or more consecutive days during the run-in period.
-Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to the firs screening visit (Visit 1).
-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 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 in the opinion of the investigator within the past two years.
-Pregnant or nursing woman.
-Women of childbearing potential not using a highly effective method of birth control.
-Patients who have taken an investigational drug within four weeks prior to Visit 1.
-Patients with known hypersensitivity to anticholinergic drugs, ciclesonide or any other component of the trial medications.
-Patients with any asthma exacerbation or any lower or upper respiratory tract infection 4 weeks prior Visit 1.
-Patients who have previously been randomised in this trial or are currently participating in another trial.
-patients treated with oral corticosteroid, long-acting anticholinergic agent, beta-blocker medication 4 weeks prior Visit 1 or cromone, methylxanthines 2 weeks before Visit 1, or Anti-IgE antibodies 6 months prior Visit 1.

Study & Design

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