Back to resultsA Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma. (NIMBUS)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD5069
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Uncontrolled Asthma,, Exacerbation,, Safety
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
AZD5069 5 mg
AZD5069 15 mg
AZD5069 45 mg
Placebo
Arm Description
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administered twice daily
Outcomes
Primary Outcome Measures
Rate of Severe Asthma Exacerbations During 6 Months
Secondary Outcome Measures
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 Cortecosteroids, Due to a Worsening of Asthma Symptoms
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
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
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
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
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
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
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
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
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
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
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
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
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).
Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)
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).
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.
Number of Patients Presenting Improvement From Baseline to End 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.
Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days
Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days
Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days
Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days
Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days
Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days
Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days
Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days
Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days
Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms
Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms
Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms
Number of Participants With Well Controlled Asthma Weeks at Baseline
Number of Well Controlled Asthma Weeks During Treatment
Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline
Number of Uncontrolled Persistent Asthma Weeks During Treatment
Mean Plasma Concentration of AZD5069 at Day 7
Mean Plasma Concentration of AZD5069 at 1 Month
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01704495
Brief Title
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
Acronym
NIMBUS
Official Title
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
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Uncontrolled Asthma,, Exacerbation,, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD5069 5 mg
Arm Type
Experimental
Arm Description
AZD5069 oral capsules self-administered twice daily
Arm Title
AZD5069 15 mg
Arm Type
Experimental
Arm Description
AZD5069 oral capsules self-administered twice daily
Arm Title
AZD5069 45 mg
Arm Type
Experimental
Arm Description
AZD5069 oral capsules self-administered twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral capsules self-administered twice daily
Intervention Type
Drug
Intervention Name(s)
AZD5069
Intervention Description
AZD5069 oral capsules self-administered twice daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral capsules self-administered twice daily.
Primary Outcome Measure Information:
Title
Rate of Severe Asthma Exacerbations During 6 Months
Time Frame
From start of treatment up to 6 months
Secondary Outcome Measure Information:
Title
Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months
Time Frame
From start of treatment up to 6 months
Title
Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions
Time Frame
From start of treatment up to 6 months
Title
Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms
Time Frame
From start of treatment up to 6 months
Title
Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1
Description
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
Title
Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1
Description
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
Title
Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1
Description
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
Title
Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1
Description
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
Title
Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1
Description
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
Title
Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1
Description
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
Title
Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1
Description
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
Title
Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1
Description
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
Title
Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1
Description
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
Title
Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1
Description
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
Title
Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1
Description
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
Title
Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1
Description
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
Title
Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score
Description
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)
Title
Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)
Description
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) and 6 months after Day 0
Title
Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score
Description
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)
Title
Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score
Description
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) and 6 months after Day 0
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Number of Participants With Well Controlled Asthma Weeks at Baseline
Time Frame
Last 2 weeks before randomization
Title
Number of Well Controlled Asthma Weeks During Treatment
Time Frame
Day 1to end of the 6 months treatment period
Title
Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline
Time Frame
Last 2 weeks before randomization
Title
Number of Uncontrolled Persistent Asthma Weeks During Treatment
Time Frame
Day 1 to end of the 6 months treatment period
Title
Mean Plasma Concentration of AZD5069 at Day 7
Time Frame
Day 7
Title
Mean Plasma Concentration of AZD5069 at 1 Month
Time Frame
at 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
150 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bengt Larsson, MEDICAL SCIENCE DIRECTOR
Organizational Affiliation
AZ Mondal R&D, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Gotse Delchev
Country
Bulgaria
Facility Name
Research Site
City
Kozloduy
Country
Bulgaria
Facility Name
Research Site
City
Petrich
Country
Bulgaria
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Razgrad
Country
Bulgaria
Facility Name
Research Site
City
Ruse
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Vidin
Country
Bulgaria
Facility Name
Research Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Saint-Romuald
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
Facility Name
Research Site
City
Brno
Country
Czech Republic
Facility Name
Research Site
City
Jindrichuv Hradec
Country
Czech Republic
Facility Name
Research Site
City
Karlovy Vary
Country
Czech Republic
Facility Name
Research Site
City
Kutna Hora
Country
Czech Republic
Facility Name
Research Site
City
Melnik
Country
Czech Republic
Facility Name
Research Site
City
Praha 5
Country
Czech Republic
Facility Name
Research Site
City
Praha 6
Country
Czech Republic
Facility Name
Research Site
City
Strakonice
Country
Czech Republic
Facility Name
Research Site
City
Tabor
Country
Czech Republic
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Großhansdorf
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Hannover
Country
Germany
Facility Name
Research Site
City
München
Country
Germany
Facility Name
Research Site
City
Aszód
Country
Hungary
Facility Name
Research Site
City
Baja
Country
Hungary
Facility Name
Research Site
City
Balassagyarmat
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Cegléd
Country
Hungary
Facility Name
Research Site
City
Gyula
Country
Hungary
Facility Name
Research Site
City
Komárom
Country
Hungary
Facility Name
Research Site
City
Makó
Country
Hungary
Facility Name
Research Site
City
Monor
Country
Hungary
Facility Name
Research Site
City
Nyíregyháza
Country
Hungary
Facility Name
Research Site
City
Pécs
Country
Hungary
Facility Name
Research Site
City
Szeged
Country
Hungary
Facility Name
Research Site
City
Szombathely
Country
Hungary
Facility Name
Research Site
City
Százhalombatta
Country
Hungary
Facility Name
Research Site
City
Guadalajara
Country
Mexico
Facility Name
Research Site
City
Mexico
Country
Mexico
Facility Name
Research Site
City
Monterrey
Country
Mexico
Facility Name
Research Site
City
Białystok
Country
Poland
Facility Name
Research Site
City
Gdańsk
Country
Poland
Facility Name
Research Site
City
Giżycko
Country
Poland
Facility Name
Research Site
City
Kraków
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Poznań
Country
Poland
Facility Name
Research Site
City
Proszowice
Country
Poland
Facility Name
Research Site
City
Skierniewice
Country
Poland
Facility Name
Research Site
City
Tarnów
Country
Poland
Facility Name
Research Site
City
Wrocław
Country
Poland
Facility Name
Research Site
City
Łódź
Country
Poland
Facility Name
Research Site
City
Żnin
Country
Poland
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Constanta
Country
Romania
Facility Name
Research Site
City
Deva
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
Research Site
City
Izhevsk
Country
Russian Federation
Facility Name
Research Site
City
Kazan
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Vladikavkaz
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Research Site
City
Bardejov
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Komarno
Country
Slovakia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Levice
Country
Slovakia
Facility Name
Research Site
City
Poprad
Country
Slovakia
Facility Name
Research Site
City
Spisska Nova Ves
Country
Slovakia
Facility Name
Research Site
City
Surany
Country
Slovakia
Facility Name
Research Site
City
Topolcany
Country
Slovakia
Facility Name
Research Site
City
Trencin
Country
Slovakia
Facility Name
Research Site
City
Zvolen
Country
Slovakia
Facility Name
Research Site
City
Amanzimtoti
Country
South Africa
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Durban
Country
South Africa
Facility Name
Research Site
City
Pretoria
Country
South Africa
Facility Name
Research Site
City
Umkomaas
Country
South Africa
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhya
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhzya
Country
Ukraine
Facility Name
Research Site
City
Zaporozye
Country
Ukraine
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Dundee
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27574788
Citation
O'Byrne PM, Metev H, Puu M, Richter K, Keen C, Uddin M, Larsson B, Cullberg M, Nair P. Efficacy and safety of a CXCR2 antagonist, AZD5069, in patients with uncontrolled persistent asthma: a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2016 Oct;4(10):797-806. doi: 10.1016/S2213-2600(16)30227-2. Epub 2016 Aug 27.
Results Reference
derived
Learn more about this trial
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
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