Bioavailability of symbicort with & without spacer in healthy subjects
Research type
Research Study
Full title
A RANDOMISED, OPEN-LABEL, SINGLE-DOSE, SINGLE-CENTRE, CROSSOVER STUDY IN HEALTHY SUBJECTS TO ASSESS THE RELATIVE BIOAVAILABILITY OF SYMBICORT pMDI 160/4.5 µg ADMINISTERED WITH A SPACER (WITH AND WITHOUT CHARCOAL) AND SYMBICORT pMDI 160/4.5 µg ADMINISTERED WITHOUT A SPACER (WITH AND WITHOUT CHARCOAL)
IRAS ID
209117
Contact name
Pablo Forte Soto
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2016-001866-27
Duration of Study in the UK
0 years, 3 months, 23 days
Research summary
The study drug administered in this study is called Symbicort®. Symbicort® is used for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. Asthma is a respiratory condition marked by attacks of spasm in the bronchi of the lungs, causing difficulty in breathing. COPD is a long-term inflammatory lung disease that causes obstructed airflow from the lungs.
Symbicort is available in two different formulations. The pressurized inhalation, suspension formulation (Symbicort pMDI), is the study drug. Symbicort pMDI was first approved in Switzerland in 2005 for treatment of asthma. In August 2016, Symbicort (both formulations) was approved in approximately 120 countries.
In this study, the study drug, administered with a spacer will be compared with the study drug administered without a spacer. A spacer (also sometimes called a holding chamber) is a medical device that attaches to the inhaler on one end and to a mouthpiece or mask on the other end. When the medication from the inhaler is released into the spacer, it's held inside until it's inhaled through the mouthpiece or mask. The purpose of the spacer is to make the coordination of inhalation and actuation less important.
The study, will investigate the amount of the study drug that is absorbed in the blood through the lungs and digestive system, with and without a spacer. In order to assess the amount of study drug absorbed through the lungs, charcoal will be administered. Charcoal will ensure that any of the study drug that may be caught in the throat, when inhaled or swallowed, is not absorbed in the stomach, which results in measuring the amount of the study drug in the lungs only.
The study will also investigate how the study drug delivered with the spacer compared to without a spacer is taken up, metabolized (chemically broken down), distributed through the body and excreted (pharmacokinetics [PK]).
A further aim is to look at how safe single doses of the study drug are when administered to healthy participants.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0461
Date of REC Opinion
20 Sep 2016
REC opinion
Favourable Opinion