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
- Conditions
- J45 NULL
- Registration Number
- PER-009-23
- Lead Sponsor
- sanofi-aventis Recherche & Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Without startig enrollment
- Sex
- All
- Target Recruitment
- 0
Age
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
Syndrome).
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
infections
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method