Device robustness study after dosing MGR001 in asthma & COPD Subjects
Research type
Research Study
Full title
An Open Study to Assess the Robustness of the CRC749 Device by Pharmaceutical Performance Following Twice Daily Dosing of MGR001 Administered via Oral Inhalation in Subjects with Asthma or Chronic Obstructive Pulmonary Disease (COPD)
IRAS ID
174775
Contact name
Muna Albayaty
Contact email
Sponsor organisation
PAREXEL International
Eudract number
2015-000463-13
Duration of Study in the UK
0 years, 2 months, 10 days
Research summary
The study drug does not yet have a name and it is not yet licensed. It is only known by the number MGR001. Mylan is developing the study drug to be used as a treatment for asthma and obstructive pulmonary disease (COPD). The study drug contains a combination of 250μg fluticasone propionate and 50μg salmeterol and is intended to be bioequivalent (effects the body and is processed by the body, in the same way) to products with a fixed dose combination of fluticasone propionate and salmeterol, which are already available on the market for e.g. Seretide®.
A new device, the CRC749 inhaler (referred to as “inhaler” throughout this document) will be tested for its robustness (how resistant the inhaler is to damage) over 22 days of twice daily dosing. The inhalers will be used to administer a new drug called MGR001 (containing fluticasone propionate and salmeterol). The robustness of the inhaler will be determined by in vitro (pharmaceutical performance) testing performed on the inhalers after use by the subjects.
Approximately 110 male and female subjects will take part in the entire study. The study will recruit 10 to 20 subjects with asthma aged 12 to 17 years and 10 to 30 subjects with asthma or (COPD) aged 65 and older. The remainder of the subjects will be subjects with asthma aged 18 years and older and subjects with COPD aged 40 years and older.
This study will take place at the PAREXEL Early Phase Clinical Unit situated in London and at the Medicines Evaluation Unit (MEU) situated in Manchester.
Vital signs (blood pressure and pulse rate), safety ECG measurements, physical examinations, lung function, urine pregnancy test (females only), adverse events and concomitant medications will be monitored throughout the entire investigational period.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0260
Date of REC Opinion
5 May 2015
REC opinion
Further Information Favourable Opinion