Phase 2
N=640
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01704495 ↗Enrolled (actual)
640
Serious AEs
6.7%
Results posted
Mar 2016
Primary outcome: Primary: Rate of Severe Asthma Exacerbations During 6 Months — 0.31; 0.31; 0.26; 0.20 Exacerbations per 6 month — p=0.119
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD5069 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Severe Asthma Exacerbations During 6 Months |
0.31; 0.31; 0.26; 0.20 | 0.119 |
| SECONDARY Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months |
0.04; 0.02; 0.02; 0.02 | — |
| SECONDARY Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions |
0.54; 0.82; 0.00; 0.08 | — |
| SECONDARY Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms |
2.38; 2.43; 2.74; 1.55 | — |
| SECONDARY Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1 |
0.13; 0.07; 0.09; 0.12 | — |
| SECONDARY Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1 |
0.14; 0.08; 0.09; 0.09 | — |
| SECONDARY Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1 |
0.13; 0.08; 0.07; 0.12 | — |
| SECONDARY Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1 |
0.10; 0.11; 0.06; 0.06 | — |
| SECONDARY Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1 |
0.17; 0.17; 0.14; 0.16 | — |
| SECONDARY Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1 |
0.14; 0.09; 0.10; 0.11 | — |
| SECONDARY Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1 |
0.06; 0.05; 0.03; 0.03 | — |
| SECONDARY Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1 |
0.06; 0.05; 0.03; 0.03 | — |
| SECONDARY Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1 |
0.03; 0.04; 0.01; 0.02 | — |
| SECONDARY Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1 |
0.04; 0.04; -0.00; -0.01 | — |
| SECONDARY Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1 |
0.06; 0.06; 0.03; 0.03 | — |
| SECONDARY Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1 |
0.06; 0.02; 0.04; -0.01 | — |
| SECONDARY Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score |
-0.68; -0.66; -0.64; -0.70 | — |
| SECONDARY Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) |
72; 88; 73; 69 | — |
| SECONDARY Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score |
0.50; 0.46; 0.52; 0.52 | — |
| SECONDARY Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score |
62; 68; 69; 62 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days |
-0.4; 1.6; 1.2; 1.1 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days |
0.2; 2.6; 3.4; 3.1 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days |
1.4; 4.3; 3.0; 4.0 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days |
2.6; 5.6; 3.9; 4.4 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days |
-1.1; 1.7; 1.2; 0.9 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days |
-0.1; 3.5; 2.7; 2.8 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days |
0.9; 4.7; 3.2; 2.9 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days |
1.4; 5.7; 3.9; 2.4 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days |
4.0; 8.3; 6.8; 9.5 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days |
10.7; 17.6; 15.4; 16.4 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days |
12.3; 19.2; 19.8; 18.7 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days |
15.8; 23.1; 21.2; 20.0 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms |
-10.1; -11.1; -11.3; -8.9 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms |
-15.2; -19.0; -18.2; -15.2 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms |
-17.6; -19.8; -22.1; -16.7 | — |
| SECONDARY Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms |
-22.8; -25.5; -25.3; -21.8 | — |
| SECONDARY Number of Participants With Well Controlled Asthma Weeks at Baseline |
154; 152; 150; 152; 6; 1 | — |
| SECONDARY Number of Well Controlled Asthma Weeks During Treatment |
1.7; 1.9; 2.4; 2.3 | — |
| SECONDARY Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline |
23; 18; 26; 27; 40; 39 | — |
| SECONDARY Number of Uncontrolled Persistent Asthma Weeks During Treatment |
11.0; 10.7; 10.4; 10.9 | — |
| SECONDARY Mean Plasma Concentration of AZD5069 at Day 7 |
235.0; 69.9; 25.4 | — |
| SECONDARY Mean Plasma Concentration of AZD5069 at 1 Month |
152.2; 76.4; 25.8 | — |
Summary
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01704495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.