Obs study Patients on Fixed Dose Combination Inhaler for Asthma & COPD
Research type
Research Study
Full title
A Phase IV Real-World Multi-Country Observational Study on Patients’ Disease Control and Self-Reported Outcomes During Fixed Dose Combination Inhaler Treatment for Persistent Asthma and COPD (SPRINT)
IRAS ID
180037
Contact name
Irma Scheepstra
Contact email
Sponsor organisation
Teva Pharmaceuticals Europe BV
Duration of Study in the UK
2 years, 9 months, 29 days
Research summary
This is a multi-country, observational, prospective study in patients with asthma or chronic obstructive pulmonary disease (COPD) that are being treated using a dry powder inhaler at a stable dose twice daily for the previous 3 months. The dry power inhaler contains a fixed dose combination (FDC) of inhaled corticosteroid/long acting beta-agonist (ICS/LABA).
Data will be collected during a single routine GP appointment (study visit) after the patient has given their informed consent. No medical procedures will be performed outside of the normal daily clinical practice. All treatment decisions are made solely by the participating GP and reflect their current standard of care (according to the Global Initiative for Asthma(GINA) or Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines) and the instructions on the package inserts of the respective ICS/LABA FDC inhalers.
The participating GP (or designated staff) will collect demographic and clinical characteristics as well as health care utilisation data from the patient’s medical records. During the study visit, the patient’s respiratory disease control will be evaluated by using either the Asthma Control Test (ACT) questionnaire for the asthma cohort or the COPD Assessment Test(CAT) questionnaire and Clinical COPD Questionnaire (CCQ) for the COPD cohort. In addition, the patient will be asked to complete the EQ-5D-3L questionnaire and to self-assess adherence by completing the Morisky Medication Adherence Scale (MMAS-8). Patients who use the Spiromax® inhaler will also be asked to rate device satisfaction and most important inhaler features on 10-point scales.
To ascertain the safety profile of DuoResp Spiromax®, for these patients the occurrence of adverse drug reactions (to DuoResp Spiromax®) or of serious adverse events since start of DuoResp Spiromax® treatment will be documented.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
15/LO/1526
Date of REC Opinion
26 Aug 2015
REC opinion
Further Information Favourable Opinion