Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients

Summary

The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.

Timeline

Start

2010-10

Primary completion

2012-02

Completion

2012-02

Outcome

Missed primary endpoint

paper However, the improvement for the highest AZD1981 dose (400 mg BID) vs placebo was not statistically significant (0.02 L, P=0.58), preventing interpretation of statistical testing for the lower doses. PMID 29765200 ↗

paper failed to produce a clinically relevant improvement in lung function or any other measured end point PMID 29765200 ↗

Publications

• Bateman ED, O'Brien C, Rugman P, Luke S, Ivanov S, Uddin M. Efficacy and safety of the CRTh2 antagonist AZD1981 as add-on therapy to inhaled corticosteroids and long-acting beta2-agonists in patients with atopic asthma. Drug Des Devel Ther. 2018 May 4;12:1093-1106. doi: 10.2147/DDDT.S147389. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AZD1981	Small molecule	10 mg	—
Subject	AZD1981	Small molecule	40 mg	—
Subject	AZD1981	Small molecule	80 mg	—
Subject	AZD1981	Small molecule	100 mg	—
Subject	AZD1981	Small molecule	200 mg	—
Subject	AZD1981	Small molecule	400 mg	—

Indications