Anakinra as a Rescue Treatment for Allergic Inflammation (NCT04035109) | Clinical Trial Compass
WithdrawnPhase 1/2
Anakinra as a Rescue Treatment for Allergic Inflammation
Stopped: Study stopped due to COVID-19 pandemic.
0Started 2019-12-16
Plain-language summary
Participants with mild asthma who are sensitized to either house dust mite or cat hair allergen will undergo nasal instillation of the allergen to elicit nasal allergy symptoms. The participants will be treated in a cross-over fashion with either placebo (saline) or anakinra to determine if anakinra will reduce nasal airway eosinophil recruitment, eosinophil activation, release of inflammatory mediators, mucins, and gene expression changes in epithelial cells.
Who can participate
Age range18 Years – 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males and females ages 18-45 years, inclusive
* Subjects will have mild asthma characterized by a Forced Expiratory Volume in 1 second (FEV1) of at least 75% of predicted and FEV1/FVC (Forced Vital Capacity) ratio of at least .60 (without use of bronchodilator medications for 12 hours), consistent with lung function of persons with mild episodic or mild persistent asthma. For the purpose of this protocol, an asthmatic individual will be defined as having a) positive methacholine challenge with a provocative concentration (PC) of methacholine producing a 20% fall in FEV1 (Provocative Concentration to decrease FEV1 by 20% (PC20) methacholine) with less than or equal to 10 mg/ml; OR b) physician-diagnosed asthma.
* OR non-asthmatic individuals with allergic rhinitis
* Allergic sensitization to house dust mite (Dermatophagoides farinae) OR cat (Felis catus) as confirmed by positive immediate skin prick test response (identified previously on a general screening visit)
* Negative pregnancy test for females who are not status post hysterectomy with oophorectomy or who have not been amenorrheic for 12 months or more.
* Ability to withhold antihistamine medications for one week prior to baseline and allergen challenge visits.
* Negative quantiferon gold TB test positive tuberculosis (TB) test is a contraindication to anakinra injection). A negative TB test within the past year (either tuberculin skin test (TST) with less than 5 mm induration or negative quantif…
What they're measuring
1
Change in eosinophils per milliliter of Nasal Lavage Fluid (NLF)
Timeframe: 6 hours post-allergen challenge versus pre-allergen challenge