search
Back to results

Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients (Sweapea)

Primary Purpose

Asthma Patients

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD1981
AZD1981
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma Patients focused on measuring Efficacy, safety, tolerability, dose finding, asthma patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AZD1981 10 mg

AZD1981 40 mg

AZD1981 100 mg

AZD1981 400 mg

AZD1981 80 mg

AZD1981 200 mg

Placebo

Arm Description

AZD1981 10 mg

AZD1981 40 mg

AZD1981 100 mg

AZD1981 400 mg

AZD1981 80 mg

AZD1981 200 mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Morning and Evening PEF
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF 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.
Asthma Control Questionnaire 5-item (ACQ5)
The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline.
Adverse Events
Number of participants who had at least one adverse event during the randomized treatment period
Number of Participants With at Least One Severe Asthma Exacerbation
Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days
Number of Participants With at Least One Treatment Failure
Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.
Number of Participants With Well-controlled Asthma (ACQ5<=0.75)
The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5<=0.75 at the end of the 12-week treatment period.
Asthma Quality of Life Questionnaire (AQLQ(S))
The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline.
Asthma Symptom Score
Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.
Total Reliever Medication Use
Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline.

Full Information

First Posted
September 8, 2010
Last Updated
October 11, 2013
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT01197794
Brief Title
Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients
Acronym
Sweapea
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Patients
Keywords
Efficacy, safety, tolerability, dose finding, asthma patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD1981 10 mg
Arm Type
Experimental
Arm Description
AZD1981 10 mg
Arm Title
AZD1981 40 mg
Arm Type
Experimental
Arm Description
AZD1981 40 mg
Arm Title
AZD1981 100 mg
Arm Type
Experimental
Arm Description
AZD1981 100 mg
Arm Title
AZD1981 400 mg
Arm Type
Experimental
Arm Description
AZD1981 400 mg
Arm Title
AZD1981 80 mg
Arm Type
Experimental
Arm Description
AZD1981 80 mg
Arm Title
AZD1981 200 mg
Arm Type
Experimental
Arm Description
AZD1981 200 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD1981
Intervention Description
AZD1981 twice daily
Intervention Type
Drug
Intervention Name(s)
AZD1981
Intervention Description
AZD1981 once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match AZD1981
Primary Outcome Measure Information:
Title
Pre-bronchodilator FEV1 at the Clinic
Description
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.
Time Frame
Twelve week treatment period
Secondary Outcome Measure Information:
Title
Morning and Evening PEF
Description
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF 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.
Time Frame
Twelve week treatment period
Title
Asthma Control Questionnaire 5-item (ACQ5)
Description
The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline.
Time Frame
Twelve week treatment period
Title
Adverse Events
Description
Number of participants who had at least one adverse event during the randomized treatment period
Time Frame
Twelve week treatment period
Title
Number of Participants With at Least One Severe Asthma Exacerbation
Description
Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days
Time Frame
Twelve week treatment period
Title
Number of Participants With at Least One Treatment Failure
Description
Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.
Time Frame
Twelve week treatment period
Title
Number of Participants With Well-controlled Asthma (ACQ5<=0.75)
Description
The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5<=0.75 at the end of the 12-week treatment period.
Time Frame
Twelve week treatment period
Title
Asthma Quality of Life Questionnaire (AQLQ(S))
Description
The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline.
Time Frame
Twelve week treatment period
Title
Asthma Symptom Score
Description
Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.
Time Frame
Twelve week treatment period
Title
Total Reliever Medication Use
Description
Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline.
Time Frame
Twelve week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris O'Brien, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Fullerton
State/Province
California
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Mission Viejo
State/Province
California
Country
United States
Facility Name
Research Site
City
Rolling Hills Estates
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
San Jose
State/Province
California
Country
United States
Facility Name
Research Site
City
Wheaton
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
North Dartmouth
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Sylvania
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Collegeville
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Clinton
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Waco
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Quilmes
State/Province
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Rosario
State/Province
Santa Fe
Country
Argentina
Facility Name
Research Site
City
San Miguel de Tucuman
State/Province
Tucuman
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Mendoza
Country
Argentina
Facility Name
Research Site
City
Porto Alegre
State/Province
Brasil
Country
Brazil
Facility Name
Research Site
City
Vitoria
State/Province
ES
Country
Brazil
Facility Name
Research Site
City
Belo Horizonte
State/Province
MG
Country
Brazil
Facility Name
Research Site
City
Juiz de Fora
State/Province
MG
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Research Site
City
Florian Polis
State/Province
Santa Catarina
Country
Brazil
Facility Name
Research Site
City
Santo Andre
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Yanagawa
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Hiroshima-shi
State/Province
Hiroshima
Country
Japan
Facility Name
Research Site
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Chitose
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Kitahiroshima
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Obihiro
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Tomakomai
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Himeji
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Naka-gun
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Sakaide
State/Province
Kagawa
Country
Japan
Facility Name
Research Site
City
Fujisawa-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Nagaoka
State/Province
Niigata
Country
Japan
Facility Name
Research Site
City
Beppu
State/Province
Oita
Country
Japan
Facility Name
Research Site
City
Kurashiki-shi
State/Province
Okayama
Country
Japan
Facility Name
Research Site
City
Matsue
State/Province
Shimane
Country
Japan
Facility Name
Research Site
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Chuo
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Itabashi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Kodaira
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Nakano-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Ohota-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Kochi
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan
Facility Name
Research Site
City
Oita
Country
Japan
Facility Name
Research Site
City
Tijuana
State/Province
Baja California
Country
Mexico
Facility Name
Research Site
City
Mexico
State/Province
D.f.
Country
Mexico
Facility Name
Research Site
City
Morelia
State/Province
Michoacan
Country
Mexico
Facility Name
Research Site
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Research Site
City
Guadalajara
Country
Mexico
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Cluj Napoca
Country
Romania
Facility Name
Research Site
City
Constanta
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Tg. Mures
Country
Romania
Facility Name
Research Site
City
Ekaterinburg
State/Province
Russia
Country
Russian Federation
Facility Name
Research Site
City
Moscow
State/Province
Russia
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
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
Banska Bystrica
Country
Slovakia
Facility Name
Research Site
City
Bardejov
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Dunajska Streda
Country
Slovakia
Facility Name
Research Site
City
Hnusta
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
Liptovsky Hradok
Country
Slovakia
Facility Name
Research Site
City
Liptovsky Mikulas
Country
Slovakia
Facility Name
Research Site
City
Presov
Country
Slovakia
Facility Name
Research Site
City
Rimavska Sobota
Country
Slovakia
Facility Name
Research Site
City
Ruzomberok
Country
Slovakia
Facility Name
Research Site
City
Trencin
Country
Slovakia
Facility Name
Research Site
City
Zvolen
Country
Slovakia
Facility Name
Research Site
City
Lyttleton
State/Province
Centurion
Country
South Africa
Facility Name
Research Site
City
Durban
State/Province
Kwazulu Natal
Country
South Africa
Facility Name
Research Site
City
Amanzimtoti
Country
South Africa
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Durbanville
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
Dnipropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Odesa
Country
Ukraine
Facility Name
Research Site
City
Poltava
Country
Ukraine
Facility Name
Research Site
City
Vinytsa
Country
Ukraine
Facility Name
Research Site
City
Zaporozhye
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
29765200
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.
Results Reference
derived

Learn more about this trial

Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients

We'll reach out to this number within 24 hrs