ATALANTA
Research type
Research Study
Full title
A Phase Ib, Multicentre, Randomised, Single-blind, Parallel-group, Placebo-controlled, Study to Characterise the Pharmacokinetics and Pharmacodynamics of AZD4604 Administered via the Turbuhaler® Device in Adults with Mild Asthma
IRAS ID
1010605
Contact name
Davinder Dosanjh
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for a better way to treat asthma. Asthma is a long-term lung condition that causes the airways to narrow, swell, and create extra mucus. This can cause symptoms such as wheezing, coughing, and difficulty breathing. Asthma attacks often happen when there is inflammation in the airways of the lungs.
The trial drug AZD4604 is designed to work by blocking a specific type of protein that increases inflammation. By blocking this protein, researchers think that it could decrease inflammation in the lungs and improve people’s asthma symptoms.
In this trial, AstraZeneca want to learn more about how safe AZD4604 is and how it moves through the bodies of participants with mild asthma when it is given through 2 different inhalers. The inhalers used in this trial are called Turbuhaler® and Genuair®. Both inhalers deliver medication to the lungs in the form of a dry powder. But, past trials with AZD4604 have only been done with the Genuair inhaler and researchers want to know if the Turbuhaler works similarly.
Participants will be randomised to receive AZD4604 or placebo. Randomised means that a computer program will randomly assign the treatment each participant takes. A placebo looks like a trial drug but does not have any of the trial drug in it. The participants will be in this trial for up to about 2 months.
This trial will include about 28 participants from the UK and Germany. To join this trial, people must be 18 to 65 years of age and have mild asthma.
The treatments in this trial are taken through either a Genuair inhaler or a Turbuhaler inhaler.
To monitor the participants’ health throughout the trial, the doctors will do the following:
Test blood and urine, perform physical exams, check vital signs, test lung function, test heart function using an electrocardiogram (ECG), ask about medications and any medical problems.
The possible benefit for taking AZD4604 is the improvement of a participant’s asthma.REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0781
Date of REC Opinion
19 Nov 2024
REC opinion
Further Information Favourable Opinion