Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma
- Registration Number
- NCT01720069
- Lead Sponsor
- Vectura Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 3 VR506 VR506 VR506 inhalation powder delivered via a new dry powder inhaler device Dose 1 VR506 VR506 VR506 inhalation powder delivered via a new dry powder inhaler device Dose 2 VR506 VR506 VR506 inhalation powder delivered via a new dry powder inhaler device
- Primary Outcome Measures
Name Time Method Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16) 16 weeks The mean asthma control prednisone/prednisolone dose at end of study (week 16)
- Secondary Outcome Measures
Name Time Method 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 Change from baseline to end of study (week 16) in 5 item asthma control questionnaire (ACQ-5) mean total score (range 0 (better) to 6 (worse)). The mean total score is calculated as the mean for each subject at each visit of 5 questions, each scored from 0 (better) to 6 (worse).
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 To measure the change from baseline to end of study for the weekly mean asthma night time symptom score, scored from 0 (not at all bothered) to 6 (severely bothered).
Assessment of Acceptability of the Device 16 weeks Percentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire
Related Research Topics
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Trial Locations
- Locations (77)
Vectura Clinical Trial Site 01001
🇺🇸Los Angeles, California, United States
Vectura Clinial Trial Site 01005
🇺🇸Denver, Colorado, United States
Vectura Clinical Trial Site 01006
🇺🇸Celebration, Florida, United States
Vectura Clinical Trial Site 01015
🇺🇸Hialeah, Florida, United States
Vectura Clinical Trial Site 01012
🇺🇸Miami Lakes, Florida, United States
Vectura Clinical Trial Site 01014
🇺🇸Orlando, Florida, United States
Vectura Clinical Trial Site 01003
🇺🇸Tampa, Florida, United States
Vectura Clinical Trial Site 01011
🇺🇸Saint Louis, Missouri, United States
Vectura Clinical Trial Site 01013
🇺🇸Jersey City, New Jersey, United States
Vectura Clinical Trial Site 01004
🇺🇸Bronx, New York, United States
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