A randomized, double-blind, placebo controlled studyassessing the long-term effect of dupilumab on preventionof lung function decline in patients with uncontrolledmoderate to severe asthma

sanofi-aventis Recherche & Development0 个研究点目标入组 0 人开始时间: 2024年6月13日最近更新: 2024年8月20日

适应症

试验速览

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•I 01. Participant must be at least 18
•Type of participant and disease characteristics
•I 02. Patients with a physician diagnosis of asthma (according to GINA 2021) for =12 months.
•I 03. Treatment with medium to high dose ICS (=250 mcg of fluticasone propionate twice daily
•or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate
•or equivalent
•I 04. Pre-bronchodilator forced expiratory volume (FEV1) =80% of predicted normal for adults
•at Visits 1 and 2, prior to randomization.
•I 05. Asthma Control Questionnaire 5-question version (ACQ-5) score =1.5 at Visits 1 and 2,
•prior to randomization.
•I 06. Bronchodilator reversibility (=12% and 200 mL improvement in FEV1 post SABA
•administration) during the screening period, prior to randomization, unless reversibility test
•meeting the inclusion criteria was done within 12 months prior to Visit 1.
•I 07. FeNO =35 ppb at Visit 2, prior to randomization. Up to 550 patients can be enrolled with FeNO <35 ppb at Visit 2.
•I 08. History of =1 severe exacerbation(s) in the previous year before V1 defined as a
•deterioration of asthma requiring:
•Use of SCS for =3 days; or,
•Hospitalization or emergency room visit because of asthma, requiring SCS.
•I 09. Female
•Contraceptive use by female should be consistent with local regulations regarding the methods of
•contraception for those participating in clinical studies.
•I 10. Capable of giving signed infor

•E 01. History or clinical evidence of COPD including Asthma-COPD Overlap Syndrome
•(ACOS) or any other significant lung disease (eg, emphysema, lung fibrosis, sarcoidosis,
•interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss
•E 02. Severe asthma exacerbation requiring treatment with SCS in the past month before V1 or
•during the screening period.
•E 03. Current acute bronchospasm or status asthmaticus.
•E 04. Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated
•peripheral eosinophil counts.
•E 05. Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect
•the participant's participation in the study.
•E 06. Patients with active tuberculosis (TB) or non-tuberculous mycobacterial infection,
•or a history of incompletely treated TB will be excluded from the study.
•E 07. Known or suspected immunodeficiency, including history of invasive opportunistic
•E 08. Active malignancy or history of malignancy within 5 years before Visit 1 (screening visit),
•except completely treated in situ carcinoma of the cervix and completely treated and
•resolved non metastatic squamous or basal cell carcinoma of the skin.
•You could find other exclusions in section 5.2

发起方

sanofi-aventis Recherche & Development