A PhII to Evaluate the efficacy, safety and tolerability of AZD5069 in Patients with Uncontrolled Persistant 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 ß2 Agonists (LABA), in Patients with Uncontrolled, Persistent Asthma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001869-33-GB

Enrollment

564

Registered

2012-08-30

Start date

2013-01-18

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: AZD5069 Product Code: AZD5069 Pharmaceutical Form: Capsule, hard INN or Proposed INN: AZD5069 CAS Number: 878385-84-3

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the efficacy of 3 different doses of AZD5069 compared with placebo on the rate of severe asthma exacerbations over 6 months in adults with uncontrolled persistent asthma, despite treatment with medium to high dose inhaled corticosteroids (=fluticasone 500 µg or the equivalent daily) and long acting ß2 agonists.; Secondary Objective: To evaluate the effect of AZD5069 compared with placebo on: 1. the rate and total number of days of asthma-specific hospital admissions/Intensive Care Unit admissions 2. the total number of days on oral corticosteroids due to a worsening of asthma symptoms 3. pulmonary function 4. asthma symptoms, use of rescue medication, and asthma control derived from the eDiary 5. asthma control using the Asthma Control Questionnaire (5-item Version) and the health-related quality of life using the Asthma Quality of Life Questionnaire (Standardised Version) 6.To describe the pharmacokinetics of AZD5069 ;Primary end point(s): Rate of severe asthma exacerbations during 6 months;Timepoint(s) of evaluation of this end point: From start of treatment up to 6 months	—

Measure

Time frame

Main Objective: To determine the efficacy of 3 different doses of AZD5069 compared with placebo on the rate of severe asthma exacerbations over 6 months in adults with uncontrolled persistent asthma, despite treatment with medium to high dose inhaled corticosteroids (=fluticasone 500 µg or the equivalent daily) and long acting ß2 agonists.; Secondary Objective: To evaluate the effect of AZD5069 compared with placebo on: 1. the rate and total number of days of asthma-specific hospital admissions/Intensive Care Unit admissions 2. the total number of days on oral corticosteroids due to a worsening of asthma symptoms 3. pulmonary function 4. asthma symptoms, use of rescue medication, and asthma control derived from the eDiary 5. asthma control using the Asthma Control Questionnaire (5-item Version) and the health-related quality of life using the Asthma Quality of Life Questionnaire (Standardised Version) 6.To describe the pharmacokinetics of AZD5069 ;Primary end point(s): Rate of severe asthma exacerbations during 6 months;Timepoint(s) of evaluation of this end point: From start of treatment up to 6 months

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Secondary

Measure	Time frame
Secondary end point(s): Rate of asthma-specific hospital admission/Intensive Care Unit admissions during 6 months. Total number of days of asthma-specific hospital admission/Intensive Care Unit admissions. Total number of days on oral corticosteroids, due to a worsening of asthma symptoms. Change from baseline to 2 weeks measurement of pre-bronchodilator FEV1 Change from baseline to 1 month measurement of pre-bronchodilator FEV1 Change from baseline to 2 months measurement of pre-bronchodilator FEV1 Change from baseline to 3 months measurement of pre-bronchodilator FEV1 Change from baseline to 4 months measurement of pre-bronchodilator FEV1 Change from baseline to 6 months measurement of pre-bronchodilator FEV1 Change from baseline to 2 weeks measurement of post-bronchodilator FEV1 ; Timepoint(s) of evaluation of this end point: From start of treatment up to 6 months From start of treatment up to 6 months From start of treatment up to 6 months Baseline (Day 0) and 2 weeks after Day 0 Baseline (Day 0) and 1 month after Day 0 Baseline (Day 0) and 2 months after Day 0 Baseline (Day 0) and 3 months after Day 0 Baseline (Day 0) and 4 months after Day 0 Baseline (Day 0) and 6 months after Day 0 Baseline (Day 0) and 2 weeks after Day 0	—

Measure

Time frame

Secondary end point(s): Rate of asthma-specific hospital admission/Intensive Care Unit admissions during 6 months. Total number of days of asthma-specific hospital admission/Intensive Care Unit admissions. Total number of days on oral corticosteroids, due to a worsening of asthma symptoms. Change from baseline to 2 weeks measurement of pre-bronchodilator FEV1 Change from baseline to 1 month measurement of pre-bronchodilator FEV1 Change from baseline to 2 months measurement of pre-bronchodilator FEV1 Change from baseline to 3 months measurement of pre-bronchodilator FEV1 Change from baseline to 4 months measurement of pre-bronchodilator FEV1 Change from baseline to 6 months measurement of pre-bronchodilator FEV1 Change from baseline to 2 weeks measurement of post-bronchodilator FEV1 ; Timepoint(s) of evaluation of this end point: From start of treatment up to 6 months From start of treatment up to 6 months From start of treatment up to 6 months Baseline (Day 0) and 2 weeks after Day 0 Baseline (Day 0) and 1 month after Day 0 Baseline (Day 0) and 2 months after Day 0 Baseline (Day 0) and 3 months after Day 0 Baseline (Day 0) and 4 months after Day 0 Baseline (Day 0) and 6 months after Day 0 Baseline (Day 0) and 2 weeks after Day 0

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Countries

Bulgaria, Canada, Colombia, Czech Republic, Germany, Hungary, Mexico, Poland, Romania, Russian Federation, Slovakia, South Africa, Ukraine, United Kingdom

Contacts

Public ContactInformation Center

AstraZeneca AB

information.center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026