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

October 11, 2013 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1144

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Mendoza, Argentina
        • Research Site
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Research Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina
        • Research Site
  • Brazil
    • Brasil
      • Porto Alegre, Brasil, Brazil
        • Research Site
    • ES
      • Vitoria, ES, Brazil
        • Research Site
    • MG
      • Belo Horizonte, MG, Brazil
        • Research Site
      • Juiz de Fora, MG, Brazil
        • Research Site
    • RS
      • Porto Alegre, RS, Brazil
        • Research Site
    • SP
      • Santo Andre, SP, Brazil
        • Research Site
      • Sao Paulo, SP, Brazil
        • Research Site
    • Santa Catarina
      • Florian Polis, Santa Catarina, Brazil
        • Research Site
  • Japan
      • Kochi, Japan
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Oita, Japan
        • Research Site
    • Fukuoka
      • Yanagawa, Fukuoka, Japan
        • Research Site
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan
        • Research Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
        • Research Site
      • Chitose, Hokkaido, Japan
        • Research Site
      • Kitahiroshima, Hokkaido, Japan
        • Research Site
      • Obihiro, Hokkaido, Japan
        • Research Site
      • Sapporo, Hokkaido, Japan
        • Research Site
      • Tomakomai, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Himeji, Hyogo, Japan
        • Research Site
    • Ibaraki
      • Naka-gun, Ibaraki, Japan
        • Research Site
    • Kagawa
      • Sakaide, Kagawa, Japan
        • Research Site
    • Kanagawa
      • Fujisawa-shi, Kanagawa, Japan
        • Research Site
      • Yokohama, Kanagawa, Japan
        • Research Site
    • Niigata
      • Nagaoka, Niigata, Japan
        • Research Site
    • Oita
      • Beppu, Oita, Japan
        • Research Site
    • Okayama
      • Kurashiki-shi, Okayama, Japan
        • Research Site
    • Shimane
      • Matsue, Shimane, Japan
        • Research Site
    • Tokyo
      • Chuo, Tokyo, Japan
        • Research Site
      • Chuo-ku, Tokyo, Japan
        • Research Site
      • Itabashi-ku, Tokyo, Japan
        • Research Site
      • Kodaira, Tokyo, Japan
        • Research Site
      • Nakano-ku, Tokyo, Japan
        • Research Site
      • Ohota-ku, Tokyo, Japan
        • Research Site
  • Mexico
      • Guadalajara, Mexico
        • Research Site
    • Baja California
      • Tijuana, Baja California, Mexico
        • Research Site
    • D.f.
      • Mexico, D.f., Mexico
        • Research Site
    • Michoacan
      • Morelia, Michoacan, Mexico
        • Research Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Research Site
  • Romania
      • Brasov, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Cluj Napoca, Romania
        • Research Site
      • Constanta, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Tg. Mures, Romania
        • Research Site
  • Russian Federation
      • Novosibirsk, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
      • Vladikavkaz, Russian Federation
        • Research Site
    • Russia
      • Ekaterinburg, Russia, Russian Federation
        • Research Site
      • Moscow, Russia, Russian Federation
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • Research Site
      • Bardejov, Slovakia
        • Research Site
      • Bratislava, Slovakia
        • Research Site
      • Dunajska Streda, Slovakia
        • Research Site
      • Hnusta, Slovakia
        • Research Site
      • Komarno, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Levice, Slovakia
        • Research Site
      • Liptovsky Hradok, Slovakia
        • Research Site
      • Liptovsky Mikulas, Slovakia
        • Research Site
      • Presov, Slovakia
        • Research Site
      • Rimavska Sobota, Slovakia
        • Research Site
      • Ruzomberok, Slovakia
        • Research Site
      • Trencin, Slovakia
        • Research Site
      • Zvolen, Slovakia
        • Research Site
  • South Africa
      • Amanzimtoti, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Durbanville, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
      • Umkomaas, South Africa
        • Research Site
    • Centurion
      • Lyttleton, Centurion, South Africa
        • Research Site
    • Kwazulu Natal
      • Durban, Kwazulu Natal, South Africa
        • Research Site
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Donetsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Odesa, Ukraine
        • Research Site
      • Poltava, Ukraine
        • Research Site
      • Vinytsa, Ukraine
        • Research Site
      • Zaporozhye, Ukraine
        • Research Site
  • United States
    • California
      • 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
        • Research Site
      • San Diego, California, United States
        • Research Site
      • San Jose, California, United States
        • Research Site
    • Maryland
      • Wheaton, Maryland, United States
        • Research Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States
        • Research Site
    • Nebraska
      • Bellevue, Nebraska, United States
        • Research Site
    • Ohio
      • Sylvania, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Medford, Oregon, United States
        • Research Site
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Collegeville, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
      • Clinton, South Carolina, United States
        • Research Site
    • Texas
      • Waco, Texas, United States
        • Research Site
    • Washington
      • Tacoma, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo to match AZD1981
Experimental: AZD1981 10 mg
Drug: AZD1981
AZD1981 twice daily
Drug: AZD1981
AZD1981 once daily
Experimental: AZD1981 40 mg
Drug: AZD1981
AZD1981 twice daily
Drug: AZD1981
AZD1981 once daily
Experimental: AZD1981 100 mg
Drug: AZD1981
AZD1981 twice daily
Drug: AZD1981
AZD1981 once daily
Experimental: AZD1981 400 mg
Drug: AZD1981
AZD1981 twice daily
Drug: AZD1981
AZD1981 once daily
Experimental: AZD1981 80 mg
Drug: AZD1981
AZD1981 twice daily
Drug: AZD1981
AZD1981 once daily
Experimental: AZD1981 200 mg
Drug: AZD1981
AZD1981 twice daily
Drug: AZD1981
AZD1981 once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-bronchodilator FEV1 at the Clinic
Time Frame: Twelve week treatment period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morning and Evening PEF
Time Frame: Twelve week treatment period
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.
Twelve week treatment period
Asthma Control Questionnaire 5-item (ACQ5)
Time Frame: Twelve week treatment period
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.
Twelve week treatment period
Adverse Events
Time Frame: Twelve week treatment period
Number of participants who had at least one adverse event during the randomized treatment period
Twelve week treatment period
Number of Participants With at Least One Severe Asthma Exacerbation
Time Frame: Twelve week treatment period
Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days
Twelve week treatment period
Number of Participants With at Least One Treatment Failure
Time Frame: Twelve week treatment period
Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.
Twelve week treatment period
Number of Participants With Well-controlled Asthma (ACQ5<=0.75)
Time Frame: Twelve week treatment period
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.
Twelve week treatment period
Asthma Quality of Life Questionnaire (AQLQ(S))
Time Frame: Twelve week treatment period
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.
Twelve week treatment period
Asthma Symptom Score
Time Frame: Twelve week treatment period
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.
Twelve week treatment period
Total Reliever Medication Use
Time Frame: Twelve week treatment period
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.
Twelve week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Chris O'Brien, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

October 11, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9830C00008
  • 2010-020407-73 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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