Clinical study to evaluate the use of a new VR506 inhaler to treate severe asthma

• Conditions: Asthma; MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2011-005030-19-HU
• Lead Sponsor: Vectura Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-28
• Last Update Posted: 23 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

-Adolescents aged 12 to 17 years (inclusive) and adults aged 18 to 65 years (inclusive)
-Documented clinical history of severe asthma requiring oral prednisone/prednisolone therapy
-Adult asthmatic subjects having FEV1 =40% of predicted value based on National Health and Nutrition Examination Survey (NHANES) III reference equations for United States (US) centres, and European Community for Coal and Steel (ECCS) reference equations for all other centres
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

- Subjects who have or who have had an upper or lower respiratory tract infection within 28 days of the Screening Visit
- Subjects with asthma that required admission to an intensive care unit and/or ventilation within the previous 12 months
- History of lung cancer

Study & Design

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