A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
NIMBUS
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
2 other identifiers
interventional
1,147
13 countries
96
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Nov 2012
Typical duration for phase_2 asthma
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2012
CompletedFirst Posted
Study publicly available on registry
October 11, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
March 1, 2016
CompletedMarch 1, 2016
February 1, 2016
1.7 years
October 9, 2012
June 30, 2015
February 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Severe Asthma Exacerbations During 6 Months
From start of treatment up to 6 months
Secondary Outcomes (41)
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 of Asthma-specific Hospital Admission/Intensive Care Unit Admissions
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 2 Weeks Measurement of Pre-bronchodilator FEV1
Baseline (Day 0) and 2 weeks after Day 0
Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1
Baseline (Day 0) and 1 month after Day 0
- +36 more secondary outcomes
Study Arms (4)
AZD5069 5 mg
EXPERIMENTALAZD5069 oral capsules self-administered twice daily
AZD5069 15 mg
EXPERIMENTALAZD5069 oral capsules self-administered twice daily
AZD5069 45 mg
EXPERIMENTALAZD5069 oral capsules self-administered twice daily
Placebo
PLACEBO COMPARATORPlacebo oral capsules self-administered twice daily
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (96)
Research Site
Gotse Delchev, Bulgaria
Research Site
Kozloduy, Bulgaria
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Petrich, Bulgaria
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Pleven, Bulgaria
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Razgrad, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Vidin, Bulgaria
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Mount Pearl, Newfoundland and Labrador, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint Romuald, Quebec, Canada
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Brno, Czechia
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Jindřichův Hradec, Czechia
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Karlovy Vary, Czechia
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Kutná Hora, Czechia
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Mělník, Czechia
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Prague, Czechia
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Strakonice, Czechia
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Tábor, Czechia
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Berlin, Germany
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Großhansdorf, Germany
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Hamburg, Germany
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Hanover, Germany
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München, Germany
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Aszód, Hungary
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Baja, Hungary
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Balassagyarmat, Hungary
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Budapest, Hungary
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Cegléd, Hungary
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Gyula, Hungary
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Komárom, Hungary
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Makó, Hungary
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Monor, Hungary
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Nyíregyháza, Hungary
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Pécs, Hungary
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Százhalombatta, Hungary
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Szeged, Hungary
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Szombathely, Hungary
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Guadalajara, Mexico
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México, Mexico
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Monterrey, Mexico
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Bialystok, Poland
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Gdansk, Poland
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Giżycko, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Poznan, Poland
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Proszowice, Poland
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Skierniewice, Poland
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Tarnów, Poland
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Wroclaw, Poland
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Żnin, Poland
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Brasov, Romania
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Bucharest, Romania
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Constanța, Romania
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Deva, Romania
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Iași, Romania
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Izhevsk, Russia
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Kazan', Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Vladikavkaz, Russia
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Yaroslavl, Russia
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Yekaterinburg, Russia
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Bardejov, Slovakia
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Bratislava, Slovakia
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Komárno, Slovakia
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Košice, Slovakia
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Levice, Slovakia
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Poprad, Slovakia
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Spišská Nová Ves, Slovakia
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Šurany, Slovakia
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Topoľčany, Slovakia
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Trenčín, Slovakia
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Zvolen, Slovakia
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Cape Town, South Africa
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Durban, South Africa
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eManzimtoti, South Africa
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eMkhomazi, South Africa
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Pretoria, South Africa
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, Ukraine
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Zaporizhzhzya, Ukraine
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Zaporozye, Ukraine
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Birmingham, United Kingdom
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Dundee, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
Related Publications (1)
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.
PMID: 27574788DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Science Director Bengt Larsson
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Bengt Larsson, MEDICAL SCIENCE DIRECTOR
AZ Mondal R&D, Sweden
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2012
First Posted
October 11, 2012
Study Start
November 1, 2012
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
March 1, 2016
Results First Posted
March 1, 2016
Record last verified: 2016-02