WHO ICTRP trial

Comparison of three doses of tiotropium inhalation solution delivered via a…

EUCTR2010-018471-26-DE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2010-018471-26-DE
Public title Comparison of three doses of tiotropium inhalation solution delivered via a device called Respimat® inhaler with the aim to evaluate the efficacy and the safety of tiotropium. Patients with moderate persistent asthma will receive each treatment for 4 weeks once daily: 1.25, 2.5, 5.0 microgram tiotropium and placebo. The sequence of the 4 treatments will be randomly assigned to the patients, and neither the patient nor the treating investigator knows when the patient gets which treatment.
Scientific title A Phase II randomised, double-blind, placebo controlled, cross-over efficacy and safety comparison of three doses of tiotropium inhalation solution delivered via Respimat® inhaler (1.25, 2.5 and 5.0 µg once daily) versus placebo in patients with moderate persistent asthma.
Primary sponsor Boehringer Ingelheim Pharma GmbH & Co. KG
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Countries Ukraine;Austria;Germany
Conditions moderate persistent asthma MedDRA version: 14.0 Level: LLT Classification code 10003555 Term: Asthma bronchial System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory…
Interventions Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Pharmaceutical Form: Inhalation vapour, solution Current Sponsor code: Ba 679 Br Other descriptive…
Registration date Sep 8, 2010
Target size 120
Secondary IDs 205.380
Registry page clinicaltrialsregister.eu

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