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

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ClinicalTrials.gov Identifier: NCT01197794
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : September 10, 2013
Last Update Posted : November 6, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Asthma Patients Drug: AZD1981 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Adverse Events [ Time Frame: Twelve week treatment period ]
    Number of participants who had at least one adverse event during the randomized treatment period

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197794


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Chris O'Brien, MD AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01197794    
Other Study ID Numbers: D9830C00008
2010-020407-73 ( EudraCT Number )
First Posted: September 9, 2010    Key Record Dates
Results First Posted: September 10, 2013
Last Update Posted: November 6, 2013
Last Verified: October 2013
Keywords provided by AstraZeneca:
Efficacy
safety
tolerability
dose finding
asthma patients
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases