A Randomised Double-blind, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of VR506 From a New Dry Powder Inhaler in Subjects With Severe Persistent Asthma Requiring Oral Corticosteroid Therapy.
Overview
- Phase
- Phase 2
- Intervention
- VR506
- Conditions
- Asthma
- Sponsor
- Vectura Limited
- Enrollment
- 197
- Locations
- 77
- Primary Endpoint
- Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily regimen from a new dry powder inhaler (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 2011.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dose 1 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
Intervention: VR506
Dose 2 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
Intervention: VR506
Dose 3 VR506
VR506 inhalation powder delivered via a new dry powder inhaler device
Intervention: VR506
Outcomes
Primary Outcomes
Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
Time Frame: 16 weeks
The mean asthma control prednisone/prednisolone dose at end of study (week 16)
Secondary Outcomes
- Number of Participants With Withdrawals Due to Worsening of Asthma(16 weeks)
- Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score(Baseline and 16 weeks)
- Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)(Baseline and 16 weeks)
- Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)(Baseline and 16 weeks)
- Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Weekly Average Asthma Night-time Symptom Score(Baseline and 16 weeks)
- Assessment of Acceptability of the Device(16 weeks)