Clinical study to evaluate the use of a new VR506 inhaler to treat Asthma

• Conditions: Asthma; MedDRA version: 15.1Level: 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: EUCTR2011-001772-19-PL
• Lead Sponsor: Vectura Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-30
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

- Adolescents aged 12 to 17 years (inclusive) and adults aged 18 to 65 years (inclusive);
- Documented clinical history of asthma (i.e. made by a physician) for at least 6 months before the Screening Visit;
- Adult asthmatic subjects having FEV1 60-90% of predicted value, based on National Health and Nutrition Examination Survey (NHANES) III reference equations for US centres, and ECCS reference equations for all other centres;
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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