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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01197794
First received: September 8, 2010
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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


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

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pre-bronchodilator FEV1 at the Clinic [ Time Frame: Twelve week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Twelve week treatment period ] [ Designated as safety issue: No ]
    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) [ Time Frame: Twelve week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Twelve week treatment period ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Twelve week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Twelve week treatment period ] [ Designated as safety issue: No ]
    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) [ Time Frame: Twelve week treatment period ] [ Designated as safety issue: No ]
    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)) [ Time Frame: Twelve week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Twelve week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Twelve week treatment period ] [ Designated as safety issue: No ]
    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.


Enrollment: 1144
Study Start Date: October 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD1981 10 mg
AZD1981 10 mg
Drug: AZD1981
AZD1981 twice daily
Experimental: AZD1981 40 mg
AZD1981 40 mg
Drug: AZD1981
AZD1981 twice daily
Experimental: AZD1981 100 mg
AZD1981 100 mg
Drug: AZD1981
AZD1981 twice daily
Experimental: AZD1981 400 mg
AZD1981 400 mg
Drug: AZD1981
AZD1981 twice daily
Experimental: AZD1981 80 mg
AZD1981 80 mg
Drug: AZD1981
AZD1981 once daily
Experimental: AZD1981 200 mg
AZD1981 200 mg
Drug: AZD1981
AZD1981 once daily
Placebo Comparator: Placebo Drug: Placebo
Placebo to match AZD1981

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197794

  Show 107 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Chris O'Brien, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01197794     History of Changes
Other Study ID Numbers: D9830C00008, 2010-020407-73
Study First Received: September 8, 2010
Results First Received: July 1, 2013
Last Updated: October 11, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Mexico: Ministry of Health
Romania: National Medicines Agency
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Ukraine: Ministry of Health

Keywords provided by AstraZeneca:
Efficacy
safety
tolerability
dose finding
asthma patients

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 April 16, 2014