Status:
UNKNOWN
Inhaler Adherence in Severe Unstable Asthma
Lead Sponsor:
Beaumont Hospital
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators hypothesize that aligning digital data on PEF and adherence with the patient's own clinical course achieves better asthma control and identifies risks for future loss of control, com...
Detailed Description
The investigators hypothesize that aligning adherence, inhaler technique and digitally recorded PEF to inform patients and as the basis of prescribing decisions achieves better inhaler adherence and t...
Eligibility Criteria
Inclusion
- Must be willing to give voluntary informed consent
- Must have a clinical diagnosis of asthma supported by objective measures, one of the following by FEV1/FVC \<70% and FEV1 \<80% or - a 12% change in FEV1 following administration of a beta-agonist or spontaneously over 1 year period, a positive bronchial provocation test, or a 10% variability in PEF within a 7 day period.
- Must have a bronchodilator FEV1 \> 40% and \<80% in the past 1 year
- Current unstable asthma i.e. ACT score ≤ 19 at enrolment despite already being managed with GINA step 3-5 therapy.
- One or more courses of oral corticosteroids in the prior year, or a hospitalization or ED attendance with an asthma exacerbation in the last year
- Age 18 years or older at time of consent.
- Capable of understanding and complying with the requirements of the protocol, including the ability to attend for all required visits.
- Able and willing to take inhaled medication via a Diskus.
- In the opinion of the investigator suitable for use of a salmeterol/fluticasone Diskus inhaler or already using a salmeterol/fluticasone inhaler.
Exclusion
- Have used any investigational product or device within 3 months of the enrolment visit.
- Have known previous sensitivity to Seretide (salmeterol/fluticasone).
- Have a known significant (in the opinion of the investigator) concurrent medical disease, pregnancy that might mean that the participant cannot complete the study.
- Be taking omalizumab or other biological agent used in the treatment of asthma
- Concurrent treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors; Ketoconazole and Ritonavir.
- Current smokers and ex-smokers with a greater than 20 pack year history of cigarette smoke
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT02307669
Start Date
December 1 2015
End Date
December 31 2020
Last Update
August 16 2019
Active Locations (1)
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1
Beaumont Hospital
Dublin, Ireland, 9