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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00758589
First received: September 23, 2008
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Asthma
Drug: AZD1981
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Morning Peak Expiratory Flow (mPEF) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)


Secondary Outcome Measures:
  • Evening Peak Expiratory Flow (ePEF) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period)

  • Morning Forced Expiratory Volume in 1 Second (mFEV1) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)

  • Evening Forced Expiratory Volume in 1 Second (eFEV1) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)

  • Total Use of Reliever [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period)

  • Night-time Asthma Symptom Score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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).

  • Day-time Asthma Symptom Score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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).

  • Awakenings [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period)

  • Asthma Control Day [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Symptom Free Day [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Reliever Free Day [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Forced Expiratory Volume in 1 Second (FEV1) at the Clinic [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Mean FEV1 during the treatment period (mean value at Week 4)

  • Forced Vital Capacity (FVC) at the Clinic [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Mean FVC during the treatment period (mean value at Week 4)

  • Asthma Control Questionnaire 5 Items (ACQ5) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Mean ACQ5 score during the treatment period (mean value at Week 4). Scores range from 0 (good) to 6 (poor control).

  • Adverse Event (AE) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Number of patients reporting at least one event


Enrollment: 368
Study Start Date: September 2008
Study Completion Date: July 2009
Arms Assigned Interventions
Experimental: AZD1981 50 mg
AZD1981 50 mg Twice Daily (Bid)
Drug: AZD1981
Oral tablet, 50 mg twice daily
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Experimental: AZD1981 400 mg
AZD1981 400 mg Twice Daily (Bid)
Drug: AZD1981
Oral tablet, 400 mg twice daily
Experimental: AZD1981 1000 mg
AZD1981 1000 mg Twice Daily (Bid)
Drug: AZD1981
Oral tablet, 1000 mg twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758589

Locations
Argentina
Research Site
Quilmes, Buenos Aires, Argentina
Research Site
San Miguel de Tucuman, Tucuman, Argentina
Research Site
Buenos Aires, Argentina
Research Site
Santa Fe, Argentina
Brazil
Research Site
Porto Alegre, Brasil, Brazil
Research Site
Rio de Janeiro, RJ, Brazil
Research Site
Santo Andre, SP, Brazil
Research Site
Sao Paulo, SP, Brazil
Costa Rica
Research Site
Barrio Los Yoses, San Jose, Costa Rica
Research Site
San Francisco de Dos Rios, San Jose, Costa Rica
Poland
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Piotr Kuna University of Lodz, Lodz, Poland
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00758589     History of Changes
Other Study ID Numbers: D9830C00004
Study First Received: September 23, 2008
Results First Received: July 1, 2013
Last Updated: January 24, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Poland: Ministry of Health
Costa Rica: Ethics Committee

Keywords provided by AstraZeneca:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014