D3551C00001 Ph II Study in Pts with Uncontrolled Persistent Asthma

• Research type

  Research Study

• Full title

  D3551C00001 - A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting beta2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

• IRAS ID

  114845

• Contact name

  Neil Christopher Barnes

• Sponsor organisation

  AstraZeneca UK

• Eudract number

  2012-001869-33

• ISRCTN Number

  xx

• Research summary

  Despite currently available therapies, asthma exacerbations continue to constitute a significant risk to the health of patients with asthma. AZD5069 is currently being developed as an add-on treatment to medium/high dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) in patients with persistent uncontrolled asthma. This study will investigate whether the addition of AZD5069 capsules twice daily to a patient's current ICS and LABA regimen reduces the number of severe exacerbations (worsening of asthma symptoms requiring additional medication with oral corticosteroids or hospitalisation) when compared to adding placebo (a dummy treatment with no active ingredient) during a 6-month treatment period. Three different doses of AZD5069 will be investigated in the study and patients will be randomly assigned to one of these doses or to placebo, hence three quarters of participating patients will receive active study medication. The study treatment period will be 6 months, with the option for patients to continue into a 6 month extension study to find out more about the long term effects of AZD5069. Regular visits to the clinic are required for the whole duration of the study, to assess safety (including blood and urine profile, ECGs, blood pressure) as well as to determine the effect of the drug on lung function tests (assessed using spirometry equipment) and to measure levels of AZD5069 in the blood, as well as determining how well the treatment is tolerated by patients. Patients will also be issued with an electronic diary and spirometer for use at home to record lung function, asthma symptoms, use of reliever medication and compliance with investigational product in the morning and evening. Approximately 564 patients will take part in 12 to 15 countries worldwide.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/1890

• Date of REC Opinion

  18 Jan 2013

• REC opinion

  Further Information Favourable Opinion