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Completed

NCT Number: NCT00758589

One 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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1981

Drug

Oral tablet, 50 mg twice daily

Placebo

Drug

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  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)

  5. 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).

  6. 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).

  7. 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)

  8. 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.

  9. 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.

  10. 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.

  11. 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)

  12. Forced Vital Capacity (FVC) at the Clinic

    Time frame: Week 4

    Mean FVC during the treatment period (mean value at Week 4)

  13. 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).

  14. Adverse Event (AE)

    Time frame: 4 weeks

    Number of patients reporting at least one event

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: OLIVE

Important dates

Study start
2008
Study completion
2009
First posted
Sep 25, 2008
Registry last updated
Feb 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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