NCT03648320
Completed
Not Applicable
A Single Arm Phase II Efficacy Study of Peanut Oral Immunotherapy in Adults
Guy's and St Thomas' NHS Foundation Trust1 site in 1 country33 target enrollmentStarted: October 15, 2018Last updated:
ConditionsPeanut Allergy
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Desensitisation to 1.4g peanut
Overview
Brief Summary
To determine efficacy and safety of peanut oral immunotherapy in adults with peanut allergy.
Detailed Description
25 adults with peanut allergy, as confirmed by double blind placebo controlled food challenge (DBPCFC), will undergo peanut oral immunotherapy (OIT) with peanut flour.
An additional 15 untreated peanut allergic adults will be recruited as comparator group for skin prick tests and mechanistic studies/immunological assays.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •For peanut OIT patients:
- •Adults aged 18-40 years with:
- •A positive skin prick test to peanut extract.
- •Elevated (\>0.35) serum specific Immunoglobulin E (IgE) to Ara h 2 major peanut allergen within 2 years of date of initial screening visit.
- •Positive DBPCFC to 300mg or less of peanut protein.
- •Where appropriate, use of effective form of birth control by females for the duration of participation in the study (i.e. up to exit DBPCFC).
- •Participants with asthma may be included if well controlled:
- •Asthma control questionnaire (ACQ) score \<1
- •Maximum permitted asthma treatment: moderate dose of inhaled corticosteroid (ICS) and long-acting beta agonists (LABA) as treatment
- •Pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) \>80% of predicted value at screening visit
Exclusion Criteria
- •For peanut OIT patients:
- •Anaphylaxis to a food other than peanut - despite attempted avoidance - within the last 2 years.
- •History of life-threatening anaphylaxis or angioedema, including previous intensive care unit (ITU) admission attributable peanut allergy.
- •Asthmatic treated with higher than moderate dose of ICS (\>800 mcg equivalent of beclomethasone dipropionate (BDP) per day).
- •Any asthmatic if uncontrolled or difficult to control as evidenced by any following: ACQ\>1; FEV1 \<80% predicted; FEV1/ forced vital capacity (FVC) \<0.7 irrespective of treatment; hospital attendance (A\&E or admission) for asthma in the past 2 years; treatment of asthma with oral steroids within last 2 years.
- •Evidence of non-adherence with asthma treatment from General PRactitioner (GP) repeat prescription records.
- •Participants who react to less than 1 mg of peanut protein on DBPCFC, or who cannot tolerate at least an initial dose of 1.5 mg peanut protein on OIT initiation day.
- •Participants who react to placebo during DBPCFC.
- •Ongoing treatment with beta-blockers, biologics (such as omalizumab or mepolizumab) or systemic immunosuppressive treatment.
- •Regular ongoing use of NSAIDs for a chronic condition (NSAIDs may act as a co-factor for allergic reactions)
Outcomes
Primary Outcomes
Desensitisation to 1.4g peanut
Time Frame: 7-8 months
Tolerance of cumulative dose of 1.4g peanut protein without reaction on DBPCFC post OIT after minimum of 1 month maintenance dosing on peanut OIT
Secondary Outcomes
- Incidence of adverse events related to treatment (safety)(7-8 months)
- Reactions with ara h 8 sensitisation(7-8 months)
- Desensitisation to 4.4g peanut(7-8 months)
- Skin prick test reactivity(9 months)
- Quality of life measure(7-8 months)
- Immunoglobulin G (IgG) levels(9 months)
- Food Situations score(7-8 months)
- Food Neophobia score(7-8 months)
- Study compliance(7-8 months)
Investigators
Study Sites (1)
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