Dupilumab asthma sleep study

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 578

Inclusion Criteria

- Physician diagnosis of asthma based on the Global Initiative for Asthma (GINA) 2020 Guidelines for =12 months treated with medium to high dose inhaled corticosteroid (ICS) and a second controller (ie, long-acting beta agonist, leukotriene receptor antagonist). A third controller is allowed but not mandatory. The dose regimen should be stable for at least 1 month before the study and during the screening period
- History of at least one asthma exacerbation within 1 year prior to screening. Exacerbation is defined as deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids (oral or injectable)
- Eosinophils =150 cells/µL and FeNO =25 ppb during screening, prior to randomization
- Asthma control questionnaire (ACQ)-5 =2.5 at screening Visit 1 and Visit 2, prior to randomization
- Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) = 80% of predicted normal during screening, prior to randomization
- Exhibit bronchodilator reversibility (=12% and 200 mL improvement in FEV1 post short-acting beta agonist administration) during screening period, prior to randomization, unless reversibility test meeting the inclusion criteria was done within 6 months prior to screening Visit 1
- Weekly average nocturnal awakenings due to asthma symptoms in the week prior to screening Visit 1 is =1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 578
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Current smoker
- Former smoker for 10 years with a smoking history of >10 pack-years
- Asthma exacerbation during screening, prior to randomization
- History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome)
- History of or current evidence of clinically significant non-respiratory diseases that in the opinion of the investigator may interfere with the aims of the study or put the participant at undue risk
- Active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing would be performed on a country by country basis, according to local guidelines if required by Regulatory Authorities or ethics boards
- Diagnosed active endoparasitic infection; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization
- History of human immunodeficiency (HIV) infection or positive HIV test at screening Visit 1
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before screening
- Known or suspected immunodeficiency including history of invasive opportunistic infections, despite infection resolution
- Current evidence of clinically significant oncological disease
- History of systemic hypersensitivity or anaphylaxis to any biologic therapy
- Severe uncontrolled depression
- Sleep disturbances not related to asthma, including sleep apnea, hypersomnia, or insomnia secondary to chronic pain, atopic dermatitis (AD), COPD or other conditions
- Participant who works night shift (ie, any work between 8 pm and 6 am)
- Erratic sleep habits, as determined by the Investigator
- Restless leg syndrome or periodic limb movement disorder
- Chronic treatment with OCS for more than 2 weeks before screening Visit 1
- Participant taking sedative, anxiolytic, or hypnotic treatments, including melatonin, within 3 months before randomization
- Participant taking systemic sedative antihistamines (excluding newer generations of antihistamines) or theophylline
- Current treatment with antidepressants, lipophilic beta blockers, clonidine, opioids, or other medications known to interfere with sleep and may confound the study assessments, as determined by the Investigator
- Treatment with live (attenuated) vaccine within 4 weeks before screening Visit 1

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of dupilumab on sleep;Secondary Objective: -To evaluate the effect of dupilumab on additional patient reported sleep outcomes<br>-To evaluate the effect of dupilumab on objective sleep assessment<br>-To evaluate the effect of dupilumab on asthma symptoms<br>-To evaluate the effect of dupilumab on lung function<br>-To evaluate the safety of dupilumab ;Primary end point(s): Change in sleep disturbance score in Asthma Sleep Disturbance Questionnaire ; Change from baseline to Week 12 in sleep disturbance score using the Asthma Sleep Disturbance Questionnaire;Timepoint(s) of evaluation of this end point: Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method

Updated 12/10/2019

Dupilumab asthma sleep study

Recruitment & Eligibility

Study & Design

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