Clinical trial NCT01197794: Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma Patients
Keywords: Efficacy
safety
tolerability
dose finding
asthma patients
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 1144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.


Eligibility criteria: Inclusion Criteria:

* Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
* 6 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pre-bronchodilator FEV1 at the Clinic
timeFrame: Twelve week treatment period
Secondary outcomes:
measure: Morning and Evening PEF
timeFrame: Twelve week treatment period
measure: Asthma Control Questionnaire 5-item (ACQ5)
timeFrame: Twelve week treatment period
measure: Adverse Events
timeFrame: Twelve week treatment period
measure: Number of Participants With at Least One Severe Asthma Exacerbation
timeFrame: Twelve week treatment period
measure: Number of Participants With at Least One Treatment Failure
timeFrame: Twelve week treatment period
measure: Number of Participants With Well-controlled Asthma (ACQ5<=0.75)
timeFrame: Twelve week treatment period
measure: Asthma Quality of Life Questionnaire (AQLQ(S))
timeFrame: Twelve week treatment period
measure: Asthma Symptom Score
timeFrame: Twelve week treatment period
measure: Total Reliever Medication Use
timeFrame: Twelve week treatment period
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Mission Viejo
country: United States
facility: Research Site
state: California
city: Rolling Hills Estates
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Jose
country: United States
facility: Research Site
state: California
city: Wheaton
country: United States
facility: Research Site
state: Maryland
city: North Dartmouth
country: United States
facility: Research Site
state: Massachusetts
city: Bellevue
country: United States
facility: Research Site
state: Nebraska
city: Sylvania
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Collegeville
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Clinton
country: United States
facility: Research Site
state: South Carolina
city: Waco
country: United States
facility: Research Site
state: Texas
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Quilmes
country: Argentina
facility: Research Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
state: Brasil
city: Vitoria
country: Brazil
facility: Research Site
state: ES
city: Belo Horizonte
country: Brazil
facility: Research Site
state: MG
city: Juiz de Fora
country: Brazil
facility: Research Site
state: MG
city: Porto Alegre
country: Brazil
facility: Research Site
state: RS
city: Florian Polis
country: Brazil
facility: Research Site
state: Santa Catarina
city: Santo Andre
country: Brazil
facility: Research Site
state: SP
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Yanagawa
country: Japan
facility: Research Site
state: Fukuoka
city: Hiroshima-shi
country: Japan
facility: Research Site
state: Hiroshima
city: Asahikawa
country: Japan
facility: Research Site
state: Hokkaido
city: Chitose
country: Japan
facility: Research Site
state: Hokkaido
city: Kitahiroshima
country: Japan
facility: Research Site
state: Hokkaido
city: Obihiro
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Tomakomai
country: Japan
facility: Research Site
state: Hokkaido
city: Himeji
country: Japan
facility: Research Site
state: Hyogo
city: Naka-gun
country: Japan
facility: Research Site
state: Ibaraki
city: Sakaide
country: Japan
facility: Research Site
state: Kagawa
city: Fujisawa-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Nagaoka
country: Japan
facility: Research Site
state: Niigata
city: Beppu
country: Japan
facility: Research Site
state: Oita
city: Kurashiki-shi
country: Japan
facility: Research Site
state: Okayama
city: Matsue
country: Japan
facility: Research Site
state: Shimane
city: Chuo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Research Site
state: Tokyo
city: Kodaira
country: Japan
facility: Research Site
state: Tokyo
city: Nakano-ku
country: Japan
facility: Research Site
state: Tokyo
city: Ohota-ku
country: Japan
facility: Research Site
state: Tokyo
city: Kochi
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Tijuana
country: Mexico
facility: Research Site
state: Baja California
city: Mexico
country: Mexico
facility: Research Site
state: D.f.
city: Morelia
country: Mexico
facility: Research Site
state: Michoacan
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo Leon
city: Guadalajara
country: Mexico
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj Napoca
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Tg. Mures
country: Romania
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Russia
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Vladikavkaz
country: Russian Federation
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bardejov
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Dunajska Streda
country: Slovakia
facility: Research Site
city: Hnusta
country: Slovakia
facility: Research Site
city: Komarno
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Levice
country: Slovakia
facility: Research Site
city: Liptovsky Hradok
country: Slovakia
facility: Research Site
city: Liptovsky Mikulas
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Rimavska Sobota
country: Slovakia
facility: Research Site
city: Ruzomberok
country: Slovakia
facility: Research Site
city: Trencin
country: Slovakia
facility: Research Site
city: Zvolen
country: Slovakia
facility: Research Site
city: Lyttleton
country: South Africa
facility: Research Site
state: Centurion
city: Durban
country: South Africa
facility: Research Site
state: Kwazulu Natal
city: Amanzimtoti
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durbanville
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Umkomaas
country: South Africa
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Odesa
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Vinytsa
country: Ukraine
facility: Research Site
city: Zaporozhye
country: Ukraine
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Chris O'Brien, MD
role: STUDY_DIRECTOR
References:
citation: 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.