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FASENRA SCEI for Long-term Use

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ClinicalTrials.gov Identifier: NCT03588546
Recruitment Status : Active, not recruiting
First Posted : July 17, 2018
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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).

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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




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 ]


Information from the National Library of Medicine

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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.


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


Locations
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Japan
Research Site
Aichi, Japan, D3250C00057
Research Site
Akita, Japan, D3250C00057
Research Site
Aomori, Japan, D3250C00057
Research Site
Chiba, Japan, D3250C00057
Research Site
Ehime, Japan, D3250C00057
Research Site
Fukui, Japan, D3250C00057
Research Site
Fukuoka, Japan, D3250C00057
Research Site
Fukushima, Japan, D3250C00057
Research Site
Gifu, Japan, D3250C00057
Research Site
Gunma, Japan, D3250C00057
Research Site
Hiroshima, Japan, D3250C00057
Research Site
Hokkaido, Japan, D3250C00057
Research Site
Hyogo, Japan, D3250C00057
Research Site
Ibaraki, Japan, D3250C00057
Research Site
Ishikawa, Japan, D3250C00057
Research Site
Iwate, Japan, D3250C00057
Research Site
Kagawa, Japan, D3250C00057
Research Site
Kagoshima, Japan, D3250C00057
Research Site
Kanagawa, Japan, D3250C00057
Research Site
Kochi, Japan, D3250C00057
Research Site
Kumamoto, Japan, D3250C00057
Research Site
Kyoto, Japan, D3250C00057
Research Site
Mie, Japan, D3250C00057
Research Site
Miyagi, Japan, D3250C00057
Research Site
Nagano, Japan, D3250C00057
Research Site
Nara, Japan, D3250C00057
Research Site
Niigata, Japan, D3250C00057
Research Site
Oita, Japan, D3250C00057
Research Site
Okayama, Japan, D3250C00057
Research Site
Okinawa, Japan, D3250C00057
Research Site
Osaka, Japan, D3250C00057
Research Site
Saitama, Japan, D3250C00057
Research Site
Shiga, Japan, D3250C00057
Research Site
Shimane, Japan, D3250C00057
Research Site
Shizuoka, Japan, D3250C00057
Research Site
Tochigi, Japan, D3250C00057
Research Site
Tokyo, Japan, D3250C00057
Research Site
Tottori, Japan, D3250C00057
Research Site
Toyama, Japan, D3250C00057
Research Site
Wakayama, Japan, D3250C00057
Research Site
Yamagata, Japan, D3250C00057
Research Site
Yamaguchi, Japan, D3250C00057
Research Site
Yamanashi, Japan, D3250C00057
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Toshimitsu Tokimoto AstraZeneca KK
Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03588546    
Other Study ID Numbers: D3250C00057
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Keywords provided by AstraZeneca:
Fasenra Benralizumab Bronchial asthma
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