Asthma is a lung disease associated with tightening of air passages, making breathing difficult. Asthma symptoms include cough, breathlessness, wheezing or tight chest. The sudden worsening of those symptoms, is called asthma attack. Some medicines contain two active substances and are used to control asthma and to prevent asthma attacks. Other medicines are used to treat asthma attacks.
This study is interested in two medicines that maintain asthma under control: One medicine contains fluticasone furoate and vilanterol, the second one contains beclomethasone and formoterol. Since we are unsure if the data in the CPRD will be right to conduct the study, we will first search the CPRD and we will only continue with the full study if the data proves to be complete. This search is called feasibility study and will investigate the number of patients treated with the two medicines of interest, how often these medicines are prescribed and if the dosage instructions are complete. This study will also evaluate if patients experienced asthma attacks or suffered from other diseases, and if they needed medical care in hospital.
These results are essential to study subsequently how these asthma medicines are used and to inform doctors and patients on best practice.
Asthma management aims to achieve disease control through short-acting medications to treat acute episodes and long-term control medications to control persistent asthma. The latter include Fluticasone furoate/vilanterol (FF/VI, 92/22mcg and 184/22mcg), administered once-daily by a novel dry powder inhaler (DPI), and beclometasone/formoterol (BDP/F; 100/6mcg and 200/6mcg) administered as maintenance treatment at fixed doses via a Metered Dose Inhaler (MDI).
A study has been planned to compare treatment patterns and medication adherence associated with FF/VI 92/22mcg and 184/22mcg versus BDP/F 100/6mcg and 200/6mcg, respectively.
the study will compare FF/VI versus BDP/F in terms of:
- Time to discontinuation
- Exacerbation rates during treatment
- Use of short-acting beta-agonists
- Healthcare resources utilization
These study endpoints are provisional and would be finalized based on the outcome of the initial feasibility assessment.
The study will run in two phases:
1. Phase I will verify the feasibility of the study by assessing available data in the CPRD, specifically:
- Dosing instructions for study drugs and other respiratory medications
- Baseline comorbid conditions
- Baseline asthma exacerbation and severity/symptom measures
- Baseline health care resource utilization
2. Phase II, will only commence with positive findings from the feasibility, and will consist of the full study.
Annalisa Rubino - Chief Investigator - Evidera, Inc
Annalisa Rubino - Corresponding Applicant - Evidera, Inc
Dimitra Lambrelli - Collaborator - Evidera, Inc
Henrik Svedsater - Collaborator - GSK
John Logie - Collaborator - GlaxoSmithKline Research & Development Limited (UK)
Sharon MacLachlan - Collaborator - Evidera, Inc
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient