An open label, randomised, parallel group clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to Relvar/Breo ELLIPTA therapy, in asthmatic subjects with poor control (study 207040)
- Conditions
- bronchial asthmaasthma10006436
- Registration Number
- NL-OMON46712
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 31
* Males and females at least 18 years of age.
* Documented diagnosis of asthma.
* Asthma Control Test <20 at screening.
* Asthma Control Test (ACT) score <20 at randomization.
* Non-smokers (never smoked or not smoking for >6 months with <10 pack years history).
* Subject must have been on maintenance therapy (Fixed dose combination ICS/LABA) for 3 months. See protocol page 31 for details).
* Background asthma medication such as anti-leukotrienes and oral corticosteroids are permitted provided the dose has been stable for 1 month prior to screening.
* Female participants of childbearing potential should agree to follow the contraceptive guidance in appendix 5 of the protocol during the treatment period and for at least 5 days after the last dose of study treatment.
* History of life-threatening asthma. See protocol page 32 for details.
* Lower airway infection in the last 7 days before screening.
* COPD or other respiratory disorders. See protocol page 32 for details.
* Other diseases: See protocol page 32 for details.
* Ever received treatment with biological based therapy.
* Pregnancy or lactation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percentage of ELLIPTA doses between the beginning of month 4 and the end of<br /><br>month 6 as determined by the maintenance sensor.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Percentage of ELLIPTA doses between the beginning of month 4 and the end of<br /><br>month 6, beginning of month 1 and the end of month 3 and beginning of month 1<br /><br>and the end of month 6 as determined by the maintenance sensor. Percentage of<br /><br>rescue free days and total rescue use measured between the beginning of month 4<br /><br>and the end of month 6 as determined by the rescue sensor records of date,<br /><br>time, and number of inhaler actuations. Change from baseline in ACT total score<br /><br>at Month 6, measured at baseline and Month 6. Percentage of patients becoming<br /><br>controlled as defined as an ACT score *20 at Month 6. Percentage of patients<br /><br>with an increase from baseline * 3 in ACT total score at Month 6. Adverse<br /><br>events.</p><br>