Asthma Inflammation Research (AIR)

NeuroTherapia, Inc.

Status and phase: Invitation-only; Early Phase 1

Conditions: Asthma; Non-allergic Asthma; Allergic Asthma

Treatments: Dietary Supplement: Nutritional approach for asthma; Biological: whole lung allergen challenge; Dietary Supplement: Low Caloric Shake

Study type: Interventional

Funder types: Other

Identifiers

NCT01536522

10-1049

PAR-09-185 (Other Identifier)

Details and patient eligibility

About

The overall goal of the Asthma Inflammation Research [AIR] Translational Program is to create an integrated multidisciplinary team for the focused purpose of development of diagnostic and prognostic tests informative for airway inflammation, and for the design of innovative, targeted biologic therapeutics.

The overarching aims of the AIR program are to conceptualize, develop, and test the next-generation therapeutics, and novel asthma diagnostic and prognostic tools that will allow us to improve the standard of asthma care.

Full description

More than 20 million Americans suffer from asthma, and nearly half of asthma sufferers do not have their asthma under control. Although commonly diagnosed using physiological measures of airflow and bronchial hyperreactivity, asthma pathophysiology is related to chronic inflammation of the airway.

Current diagnostic evaluation and monitoring are inadequate for proposed practice guidelines. The most commonly used test for evaluation of asthma is the measurement of airflow obstruction by spirometry. The National Asthma Education Prevention Program (NAEPP) and Expert Panel Reports set forth grading of asthma severity based on the frequency of symptoms, airflow, and the need for inhaled beta-agonists. Practice guidelines outline that the goals of therapy for asthma are to: maintain normal activity with near normal parameters of lung function, prevent exacerbations that lead to tissue injury, and avoid medication toxicity. In order to facilitate these goals, NAEPP defines key components for management including disease monitoring and stepped care pharmacotherapy. Unfortunately, there is no optimal plan for monitoring inflammation, which causes us to fail in key components in management of asthma. Limited options for anti-inflammatory treatments to control asthma likewise often lead to substantial morbidities due to treatment with high doses of corticosteroids. Our AIR program plans to develop novel asthma monitoring tests and design targeted therapeutics, which altogether may reduce toxicities and improve the long-term health of patients.

Impact on broad scientific advancement. Our cumulative studies provide fundamental information on the molecular mechanisms that contribute to unresolving and excessive inflammation that leads to tissue remodeling. This mechanistic knowledge is of broad scientific importance as nearly all chronic human diseases are defined by prolonged and active inflammation, with tissue destruction, and failed attempts at healing. Thus, our investigations will provide comprehensive knowledge and consequent translational deliverables that may be widely applicable as diagnostic strategies and therapies in other chronic inflammatory diseases.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Asthma diagnosed by a medical specialist and/or history of positive methacholine rest and/or reversibility of >10% of FEV1
• FEV1 is within acceptable limits
• Informed Consent is present

Exclusion criteria

• Diabetes (fasting blood sugar >110 mg/dL)
• Any milk allergies
• Coconut allergies
• BMI >40 kg/m2,
• Inability to maintain diet intervention
• Current smoking or smoking history of greater than 10 pack-years
• Any other significant respiratory or cardiac disease or the presence of clinically important comorbidities, including, uncontrolled coronary artery disease, acute or and chronic renal failure

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

Nutritional Approach for Asthma

Active Comparator group

Description:

individuals will be provide a pre measured dose of medium chain triglyceride to consume along with their meals. They will be instructed to add the MCT to their meal 3 times per day

Treatment:

Dietary Supplement: Nutritional approach for asthma

Standard American Diet

Placebo Comparator group

Description:

patients will consume their usual diet with a pre measured dose of canola oil in place of the medium chain triglyceride as a control group. They will be instructed to add the placebo dose to their meal 3 times a day

Treatment:

Dietary Supplement: Nutritional approach for asthma

Alternate Day Diet

Active Comparator group

Description:

patients will consume a regular "Standard American Diet" for 4 weeks and then provided a regulated dosed quantity of low caloric value "shakes". they will consume this on alternating days

Treatment:

Dietary Supplement: Low Caloric Shake

Whole Lung Allergen Challenge

Active Comparator group

Description:

patients with or without asthma will be given controlled doses of specified allergens

Treatment:

Biological: whole lung allergen challenge