APATURA
Research type
Research Study
Full title
A Two-part Phase IIa Randomised, Double-blind, Placebo-controlled, Dose ranging, Multi centre Study to Assess Efficacy and Safety of Three Inhaled Dose Levels of AZD1402 Administered as a Dry Powder Twice Daily for Four Weeks in Adults with Asthma on Medium Dose Inhaled Corticosteroids
IRAS ID
1003809
Contact name
Anna Tinnerberg
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-002828-37
Clinicaltrials.gov Identifier
Research summary
Research Summary
This research study is organised and supported by AstraZeneca. The study purpose is to learn more about the study medication, AZD1402, to determine how safe and effective it is in treating asthma patients that regularly use medium dose inhaled corticosteroids (ICS).
In the UK, around 5.4 million people are currently receiving treatment for asthma. Asthma is a long-term condition that affects the airways carrying air in and out of the lungs. It usually causes symptoms such as coughing, wheezing and breathlessness. If asthmatics come into contact with one of their asthma triggers, it can make symptoms worse and even bring on an asthma attack. These asthma exacerbations can be life-threatening, can significantly impact the participant’s quality of life, and result in significant healthcare costs. It is estimated that 5% to 10% of asthmatics have asthma symptoms despite treatment with current therapies, highlighting the need to develop new therapies.
AZD1402 is derived from a protein found in human tears. It works by stopping inflammation caused by certain interleukins (proteins involved in inflammatory responses of the human body). AZD1402 will be administered via a Plastiape Monodose dry powder inhaler (DPI). DPIs are devices through which a dry powder formulation of a drug is delivered via the respiratory system (airways, lungs, and blood vessels).
AZD1401 will be evaluated over a 4-week period of twice daily treatment. It will be compared to a placebo which looks like AZD1401 but has no active ingredients. Participants will have a 2 in 3 chance of being given AZD1401 and a 1 in 3 chance of receiving placebo. This is a double−blind study meaning neither the participant nor the study doctor will know which medication is being administered. In total the participants would be in the study for 16 weeks.
Approximately 405 participants worldwide will participate in this study.
Summary of Results
This is a randomised, placebo-controlled, double-blinded, multi-centre, 2-part study to assess the efficacy and safety of inhaled AZD1402. Part 1 will be performed in a Lead-in Cohort for each dose level to evaluate the safety and pharmacokinetics (PK) in a population with asthma controlled on medium dose inhaled corticosteroids (ICS)-long acting beta agonists (LABA) before progressing to dosing in adults with asthma who are uncontrolled on medium-to-high dose ICS-LABA in Part 2. The study will recruit participants receiving treatment with medium dose ICS with LABA for Part 1 and participants receiving treatment with medium-to-high dose ICS with LABA for Part 2 (separate inhalers or combination product).
Part 2 will be initiated following evaluation of safety and PK at the relevant dose level in Part 1a. The entire study period for each participant in both Parts 1 and 2, is approximately 3.5 months; a 2-week Screening Period, a 4 week Run-in Period, 4 weeks of Treatment Period, and 4 weeks of Follow-Up Period.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0169
Date of REC Opinion
19 Aug 2021
REC opinion
Further Information Favourable Opinion