AsthmaPhase 2NIMBUSNCT01704495
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
A Phase 2 study testing AZD5069 in people with Asthma, run by AstraZeneca at 96 sites in 13 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 150 years
- Conditions the study is for
- Asthma
- What is being tested?
- AZD5069
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,147 participants
- Where
- 96 sitesin 13 countries
- Study dates
- Nov 2012to Aug 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 150 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
96 sites in 13 countries.
96 sites in 13 countries
Hungary14 sites
Research Site
Aszód
Research Site
Baja
Research Site
Balassagyarmat
Research Site
Budapest
Research Site
Cegléd
Research Site
Gyula
Research Site
Komárom
Research Site
Makó
Research Site
Monor
Research Site
Nyíregyháza
Research Site
Pécs
Research Site
Százhalombatta
Research Site
Szeged
Research Site
Szombathely
Poland12 sites
Research Site
Bialystok
Research Site
Gdansk
Research Site
Giżycko
Research Site
Krakow
Research Site
Lodz
Research Site
Lublin
Research Site
Poznan
Research Site
Proszowice
Research Site
Skierniewice
Research Site
Tarnów
Research Site
Wroclaw
Research Site
Żnin
Slovakia11 sites
Research Site
Bardejov
Research Site
Bratislava
Research Site
Komárno
Research Site
Košice
Research Site
Levice
Research Site
Poprad
Research Site
Spišská Nová Ves
Research Site
Šurany
Research Site
Topoľčany
Research Site
Trenčín
Research Site
Zvolen
Bulgaria8 sites
Research Site
Gotse Delchev
Research Site
Kozloduy
Research Site
Petrich
Research Site
Pleven
Research Site
Razgrad
Research Site
Rousse
Research Site
Sofia
Research Site
Vidin
Czechia8 sites
Research Site
Brno
Research Site
Jindřichův Hradec
Research Site
Karlovy Vary
Research Site
Kutná Hora
Research Site
Mělník
Research Site
Prague
Research Site
Strakonice
Research Site
Tábor
Ukraine8 sites
Research Site
Donetsk
Research Site
Ivano-Frankivsk
Research Site
Kharkiv
Research Site
Kyiv
Research Site
Vinnytsia
Research Site
Zaporizhzhya
Research Site
Zaporizhzhzya
Research Site
Zaporozye
Russia7 sites
Research Site
Izhevsk
Research Site
Kazan'
Research Site
Moscow
Research Site
Saint Petersburg
Research Site
Vladikavkaz
Research Site
Yaroslavl
Research Site
Yekaterinburg
Canada6 sites
Research Site
Hamilton, Ontario
Research Site
Montreal, Quebec
Research Site
Mount Pearl, Newfoundland and Labrador
Research Site
Québec, Quebec
Research Site
Saint Romuald, Quebec
Research Site
Toronto, Ontario
Germany5 sites
Research Site
Berlin
Research Site
Großhansdorf
Research Site
Hamburg
Research Site
Hanover
Research Site
München
Romania5 sites
Research Site
Brasov
Research Site
Bucharest
Research Site
Constanța
Research Site
Deva
Research Site
Iași
South Africa5 sites
Research Site
Cape Town
Research Site
Durban
Research Site
eManzimtoti
Research Site
eMkhomazi
Research Site
Pretoria
United Kingdom4 sites
Research Site
Birmingham
Research Site
Dundee
Research Site
Liverpool
Research Site
London
Mexico3 sites
Research Site
Guadalajara
Research Site
México
Research Site
Monterrey
About this study
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
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
Read the 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
- Conditions
- Asthma
- Being tested
- AZD5069, Placebo
- Keywords
- Uncontrolled Asthma,, Exacerbation,, Safety
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5069Drug
AZD5069 oral capsules self-administered twice daily.
PlaceboDrug
Placebo oral capsules self-administered twice daily.
| Study group | Role | What they receive |
|---|---|---|
| AZD5069 5 mg | Experimental | AZD5069 oral capsules self-administered twice daily Receives: Drug: AZD5069 |
| AZD5069 15 mg | Experimental | AZD5069 oral capsules self-administered twice daily Receives: Drug: AZD5069 |
| AZD5069 45 mg | Experimental | AZD5069 oral capsules self-administered twice daily Receives: Drug: AZD5069 |
| Placebo | Placebo comparator | Placebo oral capsules self-administered twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Severe Asthma Exacerbations During 6 Months
Measured: From start of treatment up to 6 months
Secondary outcomes (41)
Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months
Measured: From start of treatment up to 6 months
Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions
Measured: From start of treatment up to 6 months
Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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)
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).
Measured: 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.
Measured: 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
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)
Number of Participants With Well Controlled Asthma Weeks at Baseline
Measured: Last 2 weeks before randomization
Number of Well Controlled Asthma Weeks During Treatment
Measured: Day 1to end of the 6 months treatment period
Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline
Measured: Last 2 weeks before randomization
Number of Uncontrolled Persistent Asthma Weeks During Treatment
Measured: Day 1 to end of the 6 months treatment period
Mean Plasma Concentration of AZD5069 at Day 7
Measured: Day 7
Mean Plasma Concentration of AZD5069 at 1 Month
Measured: at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,147 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bengt Larsson, MEDICAL SCIENCE DIRECTOR, Study director, AZ Mondal R&D, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704495
- Sponsor's protocol ID
- D3551C00001
- Other IDs
- 2012-001869-33
- Acronym
- NIMBUS
- Status last verified
- Feb 2016
- First submitted
- 9 Oct 2012
- Last updated
- 1 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 27574788
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01704495
- Acronym / sponsor ID
- NIMBUS / D3551C00001
- Conditions
- Asthma
- Keywords
- Uncontrolled Asthma,, Exacerbation,, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,147 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Posted 1 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AZD5069 5 mg | Experimental | Drug: AZD5069AZD5069 oral capsules self-administered twice daily |
| AZD5069 15 mg | Experimental | Drug: AZD5069AZD5069 oral capsules self-administered twice daily |
| AZD5069 45 mg | Experimental | Drug: AZD5069AZD5069 oral capsules self-administered twice daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral capsules self-administered twice daily |
Who may qualify
- Ages
- 18 to 150 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD5069AZD5069 oral capsules self-administered twice daily. | Drug | AZD5069 15 mg, AZD5069 45 mg, AZD5069 5 mg |
| PlaceboPlacebo oral capsules self-administered twice daily. | Drug | Placebo |
Primary outcome
Rate of Severe Asthma Exacerbations During 6 Months
Time frame: From start of treatment up to 6 months
41 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
Time frame: Baseline (Day 0) and 2 weeks after Day 0
Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1
Time frame: Baseline (Day 0) and 1 month after Day 0
Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1
Time frame: Baseline (Day 0) and 2 months after Day 0
Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1
Time frame: Baseline (Day 0) and 3 months after Day 0
Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1
Time frame: Baseline (Day 0) and 4 months after Day 0
Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1
Time frame: Baseline (Day 0) and 6 months after Day 0
Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1
Time frame: Baseline (Day 0) and 2 weeks after Day 0
Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1
Time frame: Baseline (Day 0) and 1 month after Day 0
Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1
Time frame: Baseline (Day 0) and 2 months after Day 0
Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1
Time frame: Baseline (Day 0) and 3 months after Day 0
Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1
Time frame: Baseline (Day 0) and 4 months after Day 0
Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27574788O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bengt Larsson, MEDICAL SCIENCE DIRECTOR study director
AZ Mondal R&D, Sweden
96 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD5069 in people with Asthma, run by AstraZeneca at 96 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in Hungary, Poland, Slovakia, Bulgaria, Czechia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Severe Asthma Exacerbations During 6 Months (time frame: From start of treatment up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01704495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.