One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids (OLIVE)

January 24, 2014 updated by: AstraZeneca

A Double-blind, Randomised, Parallel Group, Multicentre Phase IIb, Placebo-Controlled, 1 Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids

The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

368

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
      • Santa Fe, Argentina
        • Research Site
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina
        • Research Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina
        • Research Site
  • Brazil
    • Brasil
      • Porto Alegre, Brasil, Brazil
        • Research Site
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Research Site
    • SP
      • Santo Andre, SP, Brazil
        • Research Site
      • Sao Paulo, SP, Brazil
        • Research Site
  • Costa Rica
    • San Jose
      • Barrio Los Yoses, San Jose, Costa Rica
        • Research Site
      • San Francisco de Dos Rios, San Jose, Costa Rica
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Gdalsk, Poland
        • Research Site
      • Kielce, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Poznal, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Tarnow, Poland
        • Research Site
      • Turek, Poland
        • Research Site
      • Wroclaw, Poland
        • 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Six months history of asthma
  • Daily use of inhaled glucocorticosteroids
  • FEV1 40-85% of predicted normal
  • Reversibility; increase in FEV1 more than 12% and 200 mL post-bronchodilator

Exclusion Criteria:

  • Other clinically relevant disease or disorders
  • History of smoking of more than 10 pack years
  • Respiratory infection within 30 days

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
Experimental: AZD1981 50 mg
AZD1981 50 mg Twice Daily (Bid)
Drug: AZD1981
Oral tablet, 50 mg twice daily
Drug: AZD1981
Oral tablet, 400 mg twice daily
Drug: AZD1981
Oral tablet, 1000 mg twice daily
Experimental: AZD1981 400 mg
AZD1981 400 mg Twice Daily (Bid)
Drug: AZD1981
Oral tablet, 50 mg twice daily
Drug: AZD1981
Oral tablet, 400 mg twice daily
Drug: AZD1981
Oral tablet, 1000 mg twice daily
Experimental: AZD1981 1000 mg
AZD1981 1000 mg Twice Daily (Bid)
Drug: AZD1981
Oral tablet, 50 mg twice daily
Drug: AZD1981
Oral tablet, 400 mg twice daily
Drug: AZD1981
Oral tablet, 1000 mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morning Peak Expiratory Flow (mPEF)
Time Frame: Week 4
Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evening Peak Expiratory Flow (ePEF)
Time Frame: Week 4
Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period)
Week 4
Morning Forced Expiratory Volume in 1 Second (mFEV1)
Time Frame: Week 4
Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)
Week 4
Evening Forced Expiratory Volume in 1 Second (eFEV1)
Time Frame: Week 4
Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)
Week 4
Total Use of Reliever
Time Frame: Week 4
Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period)
Week 4
Night-time Asthma Symptom Score
Time Frame: Week 4
Mean night-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).
Week 4
Day-time Asthma Symptom Score
Time Frame: Week 4
Mean day-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).
Week 4
Awakenings
Time Frame: Week 4
Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period)
Week 4
Asthma Control Day
Time Frame: Week 4
Mean percentage of asthma control days during the treatment period (mean of the last 2 weeks of the treatment period). An asthma control day is defined as a symptom-free day with no use of reliever medication during day and night. A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.
Week 4
Symptom Free Day
Time Frame: Week 4
Mean percentage of symptom free days during the treatment period (mean of the last 2 weeks of the treatment period). A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.
Week 4
Reliever Free Day
Time Frame: Week 4
Mean percentage of reliever free days during the treatment period (mean of the last 2 weeks of the treatment period). A reliever free day is defined as a day and a night with no use of as-needed medication.
Week 4
Forced Expiratory Volume in 1 Second (FEV1) at the Clinic
Time Frame: Week 4
Mean FEV1 during the treatment period (mean value at Week 4)
Week 4
Forced Vital Capacity (FVC) at the Clinic
Time Frame: Week 4
Mean FVC during the treatment period (mean value at Week 4)
Week 4
Asthma Control Questionnaire 5 Items (ACQ5)
Time Frame: Week 4
Mean ACQ5 score during the treatment period (mean value at Week 4). Scores range from 0 (good) to 6 (poor control).
Week 4
Adverse Event (AE)
Time Frame: 4 weeks
Number of patients reporting at least one event
4 weeks

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Piotr Kuna, University of Lodz, Lodz, Poland

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

September 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

February 26, 2014

Last Update Submitted That Met QC Criteria

January 24, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9830C00004

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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