A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
The purpose is 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 β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma
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 β2 Agonists
 (LABA), in Patients with Uncontrolled Persistent Asthma
Inclusion Criteria:

 -  Men and women aged 18 years and above. Females of childbearing potential must use a
 highly effective contraceptive method plus a condom by their male partner.

 -  Diagnosis of asthma for at least 12 months (GINA 2011)

 -  Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and
 LABA, and with a history of exacerbations during the last year

 -  Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment

 -  Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily)

 Exclusion Criteria:

 -  Any clinically significant disease or disorder (including any chronic lower
 respiratory disease other than asthma) that may put the patient at risk or influence
 study results

 -  Patients with recurrent, latent, or chronic infections

 -  Active tuberculosis or latent tuberculosis without completion of an appropriate course
 of treatment or prophylactic treatment

 -  Significant lower respiratory tract infection not resolved within 30 days prior to
 enrolment

 -  Current smoker or smoking history of more than 20 pack years