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

A randomised, double-blind, placebo controlled, parallel group, study to evaluate the efficacy and safety of VR506 inhalation powder from a new dry powder inhaler in adolescent and adult subjects with asthma. - Clinical study to evaluate the use of a new VR506 inhaler to treat Asthma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001772-19-PL

Enrollment

374

Registered

2011-09-30

Start date

2011-11-29

Completion date

Unknown

Last updated

2013-06-17

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

Conditions

Asthma MedDRA version: 15.1 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 CAS Number: 80474-14-2 Current Sponsor code: VR506 Concentration unit: µg microgram(s) Concentration type: up to

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 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

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 of VR506 inhalation powder delivered via a new inhaler in subjects with Asthma.;Secondary Objective: - To evaluate the safety and tolerability of VR506 Inhalation Powder in subjects with asthma - To evaluate the subjects' operation and handling of the new inhaler;Primary end point(s): The comparison of mean change from baseline for the morning pre-dose FEV1 value at end of study.;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 of VR506 inhalation powder delivered via a new inhaler in subjects with Asthma.;Secondary Objective: - To evaluate the safety and tolerability of VR506 Inhalation Powder in subjects with asthma - To evaluate the subjects' operation and handling of the new inhaler;Primary end point(s): The comparison of mean change from baseline for the morning pre-dose FEV1 value at end of study.;Timepoint(s) of evaluation of this end point: Start of treatment to last study visit

—

Secondary

Measure	Time frame
Secondary end point(s): Efficacy: The assessment of absolute efficacy for withdrawals due to worsening asthma; 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

Philippines, Poland, Romania, Ukraine, United States

Contacts

Public ContactClinical Trials Information

Vectura Group plc

clinicaltrialsenquiries@vectura.com+44124966 77 00

Outcome results

None listed

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