Efficacy/safety of AZD8848 in allergen challenged allergic asthma

• Research type

  Research Study

• Full title

  A double-blind, placebo-controlled, randomised, parallel group, single centre, phase IIa study to investigate the efficacy, tolerability and safety of 8 doses of AZD8848 administered intranasally once weekly in mild to moderate allergic asthma patients challenged with an inhaled allergen

• IRAS ID

  22810

• Contact name

  Brian Leaker

• Eudract number

  2009-013705-34

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  AZD8848 is a new drug tested for the treatment of asthma and allergic rhinitis (hayfever). The incidence of asthma is increasing in developed countries. One possible explanation for the increase is that a lower incidence of childhood infections may result in the immune system becoming more sensitive to allergic reactions by allergy causing substances (allergens). This study evaluated the drug in patients whose asthma may have been associated with a sensitivity to allergens. The study was conducted in two parts. The first part was small and was concerned only with the safety of AZD8848. It included 9 patients and used a lower dose of the new drug than the second part of the study. The second part had a greater number of patients, 51 in total, and looked at the therapeutic effect of a higher dose of AZD8848 and how well patients tolerated the drug. Participants were males and females up to the age of 55 years who had suffered from asthma for at least 6 months. Participants also had to show an allergic response when tested with common allergens. Treatment (AZD8848 or dummy medicine) was allocated by chance. Participants were required to attend study visits for screening, treatment and follow-up and undertake various study assessments that did not form part of their normal clinical care. Some visits required an extended stay in the clinic. Participants remained in the study for a maximum of 17 months. The study was conducted at two centres in the UK. Results from the study indicate that it is possible to improve an allergen related response in the airways (lungs) following treatment with AZD8848.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0803/104

• Date of REC Opinion

  5 Oct 2009

• REC opinion

  Further Information Favourable Opinion