Clinical Trials List
2015-08-01 - 2017-12-31
Phase III
Terminated10
ICD-10J45.998
Other asthma
ICD-10J45
Asthma
A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of dupilumab in patients with persistent asthma
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Trial Applicant
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Sponsor
sanofri
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
2 Terminated
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
8 Terminated
Audit
CRO
Co-Principal Investigator
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Annual incidence of severe exacerbations during 52 weeks of placebo-controlled treatment
The absolute change in FEV1 before bronchodilator since the basal period at week 12
Inclution Criteria
Adult and adolescent patients, diagnosed by a physician with asthma for 12 months, the diagnosis is based on the Global Asthma Initiative (GINA) 2014 guidelines and the following standards:
A) Receive at least 3 months of high-dose ICS (≥ 250 mcg of fluticasone propionate twice a day or equivalent daily dose of ICS, with a maximum dose of 2000 mcg/day of fluticasone propionate or equivalent) Dose) and the existing treatment with the second control drug (such as LABA, LTRA) and maintain a stable dose for≥ 1 month.
-For Japan: For subjects over 18 years of age, ICS must be ≥ 200 mcg of fluticasone propionate twice a day or the same dose; for subjects 12 to 17 years old, ICS must be ≥ 100 mcg of fluticasone propionate twice a day or an equivalent dose.
-Patients who need a third control drug to treat asthma are deemed to be eligible for this study, and should be used for at least 3 months before the first visit, and a stable dose should be maintained for 1 month.
B) The forced expiratory volume before bronchodilator (FEV1, forced expiratory volume 1) at the first and second visits before random allocation was 40 to 80% of the predicted normal value.
C) The scores of the 5-item Asthma control questionnaire 5-question version (ACQ-5, Asthma control questionnaire 5-question version) before the random allocation of the first and second visits were ≥ 1.5.
D) After administering 200 to 400 mcg albuterol/salbutamol (inhalation of albuterol/salbutamol or albuterol/salbutamol spray solution [if standard hospital practice] 2 to 4 times) before random allocation, FEV1 recovered at least 12% and 200 mL.
E) Any of the following events must occur within one year before the first visit:
-At least once received systemic steroids (oral or injectable) for worsening asthma.
-Hospitalized or sent to an emergency department due to worsening asthma.
Exclusion Criteria
The age of the patient is less than 12 years old or the legal minimum age of adolescents in the country where the trial center is located, whichever is higher (for countries where local regulations only allow adults to be included, subject recruitment is limited to age; 18-year-old patients).
The weight is less than 30 kg.
Chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function (such as idiopathic pulmonary fibrosis, Churg-Strauss syndrome, etc.).
Subjects with severe asthma exacerbation (defined as those who received emergency treatment, hospitalized for asthma, or received systemic steroid treatment from 1 month before the screening return to the basic period return [inclusive], as a result of the exacerbation of asthma).
Within 12 months before the first visit, clinical evidence or angiography (such as chest X-ray, computed tomography [CT, computed tomography], and magnetic resonance imaging [MRI, Magnetic resonance imaging]) of other lung diseases other than asthma was met.
Smokers or those who quit smoking within 6 months of the first visit.
Those who have quit smoking have a history of smoking> 10 packs-years.
Co-occurring diseases that may interfere with the evaluation of the trial drug.
The Estimated Number of Participants
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Taiwan
42 participants
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Global
1638 participants
