Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients
Sweapea
A Double-blind, Placebo-controlled, Randomised, Parallel-group, Phase II, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of 4 Twice Daily Doses and 2 Once Daily Doses of AZD1981 Given as Tablets During 12 Weeks in Asthmatic Patients
2 other identifiers
interventional
1,144
10 countries
105
Brief Summary
The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2010
Shorter than P25 for phase_2
105 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
September 8, 2010
CompletedFirst Posted
Study publicly available on registry
September 9, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
September 10, 2013
CompletedNovember 6, 2013
October 1, 2013
1.3 years
September 8, 2010
July 1, 2013
October 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pre-bronchodilator FEV1 at the Clinic
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
Twelve week treatment period
Secondary Outcomes (9)
Morning and Evening PEF
Twelve week treatment period
Asthma Control Questionnaire 5-item (ACQ5)
Twelve week treatment period
Adverse Events
Twelve week treatment period
Number of Participants With at Least One Severe Asthma Exacerbation
Twelve week treatment period
Number of Participants With at Least One Treatment Failure
Twelve week treatment period
- +4 more secondary outcomes
Study Arms (7)
AZD1981 10 mg
EXPERIMENTALAZD1981 10 mg
AZD1981 40 mg
EXPERIMENTALAZD1981 40 mg
AZD1981 100 mg
EXPERIMENTALAZD1981 100 mg
AZD1981 400 mg
EXPERIMENTALAZD1981 400 mg
AZD1981 80 mg
EXPERIMENTALAZD1981 80 mg
AZD1981 200 mg
EXPERIMENTALAZD1981 200 mg
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
- months history of asthma according to ATS definition
- Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
- Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
- A total ACQ5 score of 1.5 or more
You may not qualify if:
- Respiratory infection significantly affecting the asthma
- Any significant disease and disorder that may put the patient at risk or influence study results
- Any clinically relevant abnormal findings
- A smoking history of more than 10 pack years
- Intake of oral, rectal or parenteral glucocorticosteroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (105)
Research Site
Fullerton, California, United States
Research Site
Los Angeles, California, United States
Research Site
Mission Viejo, California, United States
Research Site
Rolling Hills Estates, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Wheaton, Maryland, United States
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North Dartmouth, Massachusetts, United States
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Bellevue, Nebraska, United States
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Sylvania, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Collegeville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Clinton, South Carolina, United States
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Waco, Texas, United States
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Tacoma, Washington, United States
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Buenos Aires, Argentina, Argentina
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Quilmes, Buenos Aires, Argentina
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Mendoza, Mendoza Province, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Porto Alegre, Brasil, Brazil
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Vitória, Espírito Santo, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Florian Polis, Santa Catarina, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Yanagawa, Fukuoka, Japan
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Hiroshima, Hiroshima, Japan
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Asahikawa, Hokkaido, Japan
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Chitose, Hokkaido, Japan
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Kitahiroshima, Hokkaido, Japan
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Obihiro, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Tomakomai, Hokkaido, Japan
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Himeji, Hyōgo, Japan
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Naka-gun, Ibaraki, Japan
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Sakaidechō, Kagawa-ken, Japan
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Fujisawa-shi, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kochi, Kochi, Japan
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Kyoto, Kyoto, Japan
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Nagaoka, Niigata, Japan
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Beppu, Oita Prefecture, Japan
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Ōita, Oita Prefecture, Japan
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Kurashiki-shi, Okayama-ken, Japan
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Matsue, Shimane, Japan
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Chuo-ku, Tokyo, Japan
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Chūō, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Nakano-ku, Tokyo, Japan
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Ohota-ku, Tokyo, Japan
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México, D.f., Mexico
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Tijuana, Estado de Baja California, Mexico
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Morelia, Michoacán, Mexico
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Monterrey, Nuevo León, Mexico
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Guadalajara, Mexico
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Constanța, Constanța County, Romania
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Iași, Romania
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Tg. Mures, Romania
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Moscow, Russia, Russia
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Yekaterinburg, Russia, Russia
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Novosibirsk, Russia
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Saint Petersburg, Russia
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Vladikavkaz, Russia
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Banská Bystrica, Slovakia
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Bardejov, Slovakia
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Bratislava, Slovakia
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Dunajská Streda, Slovakia
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Hnúšťa, Slovakia
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Komárno, Slovakia
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Košice, Slovakia
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Levice, Slovakia
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Liptovský Hrádok, Slovakia
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Liptovský Mikuláš, Slovakia
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Prešov, Slovakia
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Rimavská Sobota, Slovakia
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Ružomberok, Slovakia
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Trenčín, Slovakia
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Zvolen, Slovakia
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Lyttleton, Centurion, South Africa
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Durban, KwaZulu-Natal, South Africa
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Cape Town, South Africa, South Africa
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Durban, South Africa, South Africa
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eMkhomazi, South Africa, South Africa
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Durbanville, South Africa
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eManzimtoti, South Africa
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Pretoria, South Africa
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Vinytsa, Ukraine
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Zaporizhzhya, Ukraine
Related Publications (1)
Bateman ED, O'Brien C, Rugman P, Luke S, Ivanov S, Uddin M. Efficacy and safety of the CRTh2 antagonist AZD1981 as add-on therapy to inhaled corticosteroids and long-acting beta2-agonists in patients with atopic asthma. Drug Des Devel Ther. 2018 May 4;12:1093-1106. doi: 10.2147/DDDT.S147389. eCollection 2018.
PMID: 29765200DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Alison Holt
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Chris O'Brien, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2010
First Posted
September 9, 2010
Study Start
October 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
November 6, 2013
Results First Posted
September 10, 2013
Record last verified: 2013-10