A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.

AstraZeneca1,147 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,147

Conditions

Asthma

Interventions

AZD5069DRUG

AZD5069 oral capsules self-administered twice daily.

PlaceboDRUG

Placebo oral capsules self-administered twice daily.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 150 Years

Medical Language ↔ Plain English

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

Locations (96)

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

Time frame: From start of treatment up to 6 months

Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions

Time frame: From start of treatment up to 6 months

Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms

Time frame: From start of treatment up to 6 months

Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis

Time frame: Baseline (Day 0) and 2 weeks after Day 0

Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at one month are included in the analysis

Time frame: Baseline (Day 0) and 1 month after Day 0

Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at two months are included in the analysis

Time frame: Baseline (Day 0) and 2 months after Day 0

Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at three months are included in the analysis

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Research Site

Gotse Delchev, Bulgaria

Research Site

Kozloduy, Bulgaria

Research Site

Petrich, Bulgaria

Research Site

Pleven, Bulgaria

Research Site

Razgrad, Bulgaria

Research Site

Rousse, Bulgaria

Research Site

Sofia, Bulgaria

Research Site

Vidin, Bulgaria

Research Site

Mount Pearl, Newfoundland and Labrador, Canada

Research Site

Hamilton, Ontario, Canada

...and 86 more locations

Time frame: Baseline (Day 0) and 3 months after Day 0

Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at four months are included in the analysis

Time frame: Baseline (Day 0) and 4 months after Day 0

Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at six months are included in the analysis

Time frame: Baseline (Day 0) and 6 months after Day 0

Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis

Time frame: Baseline (Day 0) and 2 weeks after Day 0

Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at one month are included in the analysis

Time frame: Baseline (Day 0) and 1 month after Day 0

Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at two months are included in the analysis

Time frame: Baseline (Day 0) and 2 months after Day 0

Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at three months are included in the analysis

Time frame: Baseline (Day 0) and 3 months after Day 0

Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at four months are included in the analysis

Time frame: Baseline (Day 0) and 4 months after Day 0

Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at six months are included in the analysis

Time frame: Baseline (Day 0) and 6 months after Day 0

Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score

The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

Time frame: 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)

Time frame: Baseline (Day 0) and 6 months after Day 0

Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score

The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and \> 1.5 as marked clinically important differences for any individual domain or for the overall summary score.

Time frame: Baseline (Day 0), Treatment Period (1,3, and 6 months)

Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score

Time frame: Baseline (Day 0) and 6 months after Day 0

Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days

Time frame: 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

Time frame: 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 Symptom Free Days

Time frame: 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

Time frame: Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)

Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days

Time frame: 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 Asthma Control Days

Time frame: 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

Time frame: 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 Control Days

Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months

Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days

Time frame: 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 Use of Rescue Medication Free Days

Time frame: 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 Use of Rescue Medication Free Days

Time frame: 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 Use of Rescue Medication Free Days

Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)

Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms

Time frame: 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 Night Time Awakenings Due to Asthma Symptoms

Time frame: Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)

Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms

Time frame: Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)

Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms

Time frame: Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)

Number of Participants With Well Controlled Asthma Weeks at Baseline

Time frame: Last 2 weeks before randomization

Number of Well Controlled Asthma Weeks During Treatment

Time frame: Day 1to end of the 6 months treatment period

Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline

Time frame: Last 2 weeks before randomization

Number of Uncontrolled Persistent Asthma Weeks During Treatment

Time frame: Day 1 to end of the 6 months treatment period

Mean Plasma Concentration of AZD5069 at Day 7

Time frame: Day 7

Mean Plasma Concentration of AZD5069 at 1 Month

Time frame: at 1 month