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-GB

Lead Sponsor: Vectura Limited

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the clinical efficacy and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different total daily doses of Fluticasone Propionate Inhalation Powder taken using a twice daily regimen from nDPI for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines (GINA 2011). ;Secondary Objective: -To evaluate the safety and tolerability of 3 different total daily doses of Fluticasone Propionate Inhalation Powder in subjects with severe persistent asthma requiring OCS therapy;<br>-To evaluate the subjects’ operation and handling of the new dry powder inhaler (nDPI).<br>;Primary end point(s): Mean Prednisone/prednisolone Dose for Analysis” (PDA).;Timepoint(s) of evaluation of this end point: Start of treatment to last study visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy: Variety of calculations measuring change in dose of prednisone/prednisolone <br>Safety: Vital signs; Physical examination; Oropharyngeal examination;12-lead ECG; 24HUC;<br>Inhaler: The inhaler variables will be assessments of Compliance;<br>Operation; Acceptability.;Timepoint(s) of evaluation of this end point: Start of treatment to last study visit