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

A randomised double-blind, parallel group, dose-ranging study to evaluate the efficacy and safety of three different total daily doses of fluticasone propionate inhaled from a new dry powder inhaler in subjects with severe persistent asthma requiring oral corticosteroid therapy - Clinical study to evaluate the use of a new VR506 inhaler to treate severe asthma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005030-19-GB

Enrollment

174

Registered

2012-06-13

Start date

2012-08-17

Completion date

Unknown

Last updated

2014-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 14.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: VR506 Inhaler Product Code: VR506 Pharmaceutical Form: Inhalation powder INN or Proposed INN: FLUTICASONE PROPIONATE CAS Number: 80474-14-2 Current Sponsor code: VR506 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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; -To evaluate the subjects’ operation and handling of the new dry powder inhaler (nDPI). ;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	—

Measure

Time frame

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; -To evaluate the subjects’ operation and handling of the new dry powder inhaler (nDPI). ;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

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

Countries

Bulgaria, Canada, Germany, Hungary, Poland, Spain, Ukraine, United Kingdom, United States

Contacts

Public ContactClinical Trials Information

Vectura Group plc

clinical.enquiries@vectura.com+441249667700

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026