Clinical Trials/NCT01704495

NCT01704495

Completed

Phase 2

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

AstraZeneca1 site in 1 country1,147 target enrollmentNovember 2012

ConditionsAsthma

InterventionsAZD5069 Placebo

DrugsAZD5069 Placebo

Overview

Phase: Phase 2
Intervention: AZD5069
Conditions: Asthma
Sponsor: AstraZeneca
Enrollment: 1147
Locations: 1
Primary Endpoint: Rate of Severe Asthma Exacerbations During 6 Months
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

August 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

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

Arms & Interventions

AZD5069 45 mg

AZD5069 oral capsules self-administered twice daily

Intervention: AZD5069

AZD5069 5 mg

AZD5069 oral capsules self-administered twice daily

Intervention: AZD5069

AZD5069 15 mg

AZD5069 oral capsules self-administered twice daily

Intervention: AZD5069

Placebo

Placebo oral capsules self-administered twice daily

Intervention: Placebo

Outcomes

Primary Outcomes

Rate of Severe Asthma Exacerbations During 6 Months

Time Frame: From start of treatment up to 6 months

Secondary Outcomes

Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months(From start of treatment up to 6 months)
Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms(From start of treatment up to 6 months)
Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1(Baseline (Day 0) and 1 month after Day 0)
Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score(Baseline (Day 0), Treatment Period (1,3, and 6 months))
Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28))
Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56))
Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days(Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28))
Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms(Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28))
Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions(From start of treatment up to 6 months)
Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1(Baseline (Day 0) and 2 weeks after Day 0)
Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1(Baseline (Day 0) and 2 months after Day 0)
Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1(Baseline (Day 0) and 3 months after Day 0)
Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1(Baseline (Day 0) and 4 months after Day 0)
Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1(Baseline (Day 0) and 6 months after Day 0)
Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1(Baseline (Day 0) and 2 weeks after Day 0)
Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1(Baseline (Day 0) and 2 months after Day 0)
Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1(Baseline (Day 0) and 3 months after Day 0)
Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1(Baseline (Day 0) and 4 months after Day 0)
Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1(Baseline (Day 0) and 6 months after Day 0)
Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1(Baseline (Day 0) and 1 month after Day 0)
Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score(Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months))
Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)(Baseline (Day 0) and 6 months after Day 0)
Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score(Baseline (Day 0) and 6 months after Day 0)
Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days(Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56))
Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days(Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84))
Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84))
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days(Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months))
Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56))
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days(Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)
Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84))
Number of Well Controlled Asthma Weeks During Treatment(Day 1to end of the 6 months treatment period)
Number of Uncontrolled Persistent Asthma Weeks During Treatment(Day 1 to end of the 6 months treatment period)
Mean Plasma Concentration of AZD5069 at Day 7(Day 7)
Mean Plasma Concentration of AZD5069 at 1 Month(at 1 month)
Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28))
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days(Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months))
Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms(Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84))
Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline(Last 2 weeks before randomization)
Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms(Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56))
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms(Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months))
Number of Participants With Well Controlled Asthma Weeks at Baseline(Last 2 weeks before randomization)