A Phase 4, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of the effect of dupilumab on sleep disturbance in patients with uncontrolled persistent asthma
- Conditions
- asthmasleep disturbance1000170810010613
- Registration Number
- NL-OMON52410
- Lead Sponsor
- Genzyme Europe BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
-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 severe asthma exacerbation within 1 year prior to
screening. Severe 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 fractional exhaled nitric oxide (FeNO) >=25 ppb
during screening, prior to randomization
NOTES:
* Historical values of blood eosinophil count meeting the eligibility criterion
measured
within 6 months prior to screening Visit 1 in the absence of oral
corticosteroid (OCS)
treatment are allowed.
* FeNO value to be checked for eligibility at Visit 2 as well.
-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, and at Visit 2, 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
-Current smoker
-Former smoker for 10 years with a smoking history of >10 pack-years
-Severe 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
-Participant who has taken biologic therapy (including dupilumab)/systemic
immunosuppressant to treat inflammatory disease or autoimmune disease (eg,
rheumatoid
arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus
erythematosus, multiple sclerosis, etc) within 2 months or 5 half-lives before
screening
Visit 1, whichever is longer
-Treatment with live (attenuated) vaccine within 4 weeks before screening Visit
1
NOTE: For participants who have vaccination wit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Change in sleep disturbance score in Asthma Sleep Disturbance Questionnaire</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Change in the number of nocturnal awakenings in Sleep Diary<br /><br>- Change in PROMIS sleep-related impairment assessment<br /><br>- Change in sleep quality in Sleep Diary<br /><br>- Change in restorative sleep in Sleep Diary<br /><br>- Change in WASO in Sleep Diary<br /><br>- Change in WASO (actigraphy data)<br /><br>- Change in daytime and nighttime asthma symptoms in Asthma Daytime Symptom<br /><br>Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD)<br /><br>- Change in pre-bronchodilator (BD) FEV1<br /><br>- Incidence of Adverse events</p><br>