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FASENRA SCEI for Long-term Use

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ClinicalTrials.gov Identifier: NCT03588546
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The purpose of the investigation is to confirm the safety and efficacy under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.

Condition or disease
Asthma

Detailed Description:

The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.

  1. Detection of unexpected Adverse Drug Reactions
  2. To grasp development of Adverse Drug Reactions
  3. To grasp contributing factors possibly having an impact on the safety and efficacy
  4. Development of key investigational safety specification (serious infection).

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 780 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: FASENRA Subcutaneous Injection 30 mg Syringe Specific Clinical Experience Investigation for Long-term Use
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Incidences of adverse drug reactions (ADRs) [all ADRS, unexpected ADRs and key investigational safety specification (serious infection)] [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Change scores from baseline in Asthma Control Questionnaire (ACQ) with exploring a factor to affect them by patient's background and treatment condition [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy).
Criteria

Inclusion Criteria:

-The evaluable patients treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy).

Exclusion Criteria:

-No past history of hypersensitivity to the components of Fasenra.

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): NCT03588546


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Toshimitsu Tokimoto AstraZeneca KK
More Information
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Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03588546     History of Changes
Other Study ID Numbers: D3250C00057
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

Keywords provided by AstraZeneca:
Fasenra Benralizumab Bronchial asthma

Additional relevant MeSH terms:
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Benralizumab
Anti-Asthmatic Agents
Respiratory System Agents