FASENRA SCEI for Long-term Use
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| ClinicalTrials.gov Identifier: NCT03588546 |
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Recruitment Status :
Active, not recruiting
First Posted : July 17, 2018
Last Update Posted : November 9, 2020
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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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 |
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.
- Detection of unexpected Adverse Drug Reactions
- To grasp development of Adverse Drug Reactions
- To grasp contributing factors possibly having an impact on the safety and efficacy
- Development of key investigational safety specification (serious infection).
| 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
Drug Information available for:
Benralizumab
Primary Outcome Measures :
- Incidences of adverse drug reactions (ADRs) [all ADRS, unexpected ADRs and key investigational safety specification (serious infection)] [ Time Frame: 1 year ]
Secondary Outcome Measures :
- 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
| Japan | |
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| Aichi, Japan | |
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| Akita, Japan | |
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| Aomori, Japan | |
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| Chiba, Japan | |
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| Ehime, Japan | |
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| Fukui, Japan | |
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| Fukuoka, Japan | |
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| Fukushima, Japan | |
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| Gifu, Japan | |
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| Gunma, Japan | |
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| Hiroshima, Japan | |
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| Hokkaido, Japan | |
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| Hyogo, Japan | |
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| Ibaraki, Japan | |
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| Ishikawa, Japan | |
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| Iwate, Japan | |
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| Kagawa, Japan | |
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| Kagoshima, Japan | |
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| Kanagawa, Japan | |
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| Kochi, Japan | |
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| Kumamoto, Japan | |
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| Kyoto, Japan | |
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| Mie, Japan | |
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| Miyagi, Japan | |
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| Nagano, Japan | |
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| Nara, Japan | |
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| Niigata, Japan | |
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| Oita, Japan | |
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| Okayama, Japan | |
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| Okinawa, Japan | |
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| Osaka, Japan | |
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| Saitama, Japan | |
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| Shiga, Japan | |
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| Shimane, Japan | |
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| Shizuoka, Japan | |
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| Tochigi, Japan | |
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| Tokyo, Japan | |
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| Tottori, Japan | |
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| Toyama, Japan | |
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| Wakayama, Japan | |
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| Yamagata, Japan | |
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| Yamaguchi, Japan | |
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| Yamanashi, Japan | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Toshimitsu Tokimoto | AstraZeneca KK |
Additional Information:
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT03588546 |
| Other Study ID Numbers: |
D3250C00057 |
| First Posted: | July 17, 2018 Key Record Dates |
| Last Update Posted: | November 9, 2020 |
| Last Verified: | November 2020 |
Keywords provided by AstraZeneca:
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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 |