A PhII to Evaluate the efficacy, safety and tolerability of AZD5069 in Patients with Uncontrolled Persistant Asthma.

Phase 1

• Conditions: Asthma; MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-001869-33-GB
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-30
• Study Completion: 2014-12-19
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 640

Inclusion Criteria

1. 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.
2. Diagnosis of asthma for at least 12 months (GINA 2011)
3. Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and LABA, and with a history of exacerbations during the last year
4. Morning prebronchodilator FEV1 of =30% and =85% predicted normal at enrolment
5. Daily use of medium or high dose ICS (=fluticasone 500 µg or the equivalent daily)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 508
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

1. 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
2. Patients with recurrent, latent, or chronic infections
3. Active tuberculosis or latent tuberculosis without completion of an appropriate course of treatment or prophylactic treatment
4. Significant lower respiratory tract infection not resolved within 30 days prior to enrolment
5. Current smoker or smoking history of more than 20 pack years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified