Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Oral Administration of AIM-102 in Patients With Mild to Moderate Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, double-blind, placebo-controlled, cross-over trial to evaluate the
      efficacy of AIM-102 for the treatment of allergen-induced asthma. Individuals with stable,
      mild to moderate allergic asthma by American Thoracic Society (ATS) criteria (1), with a
      history of episodic wheeze and shortness of breath, will be eligible for enrollment.

      The patients will receive 4 consecutive days of dosing of AIM-102 or placebo (inactive
      product) with an allergen challenge on day 3 of dosing to see how the patient's lung function
      is changed by using AIM-102 or placebo.
    

Detailed description: 
      This is a Phase II, double-blind, placebo-controlled, cross-over trial to evaluate the
      efficacy of AIM-102 for the treatment of allergen-induced asthma. Individuals with stable,
      mild to moderate allergic asthma by American Thoracic Society (ATS) criteria (1), with a
      history of episodic wheeze and shortness of breath, will be eligible for enrollment.

      The study is divided into 2 parts.

      Part 1: Screening

      Patients who meet all entry criteria will be screened with a history, physical examination,
      spirometry, and routine laboratory tests. If they continue to meet entry criteria, their
      atopic status will be documented by skin testing against common airborne allergens (including
      cat, dust mite, grass, pollen). Twenty-four (24) hr later, an allergen challenge will be
      performed to confirm the presence of an Early Asthmatic Response (EAR) and Late Asthmatic
      Response (LAR). Methacholine PC20 and sputum differentials will be performed before and after
      allergen challenges. Only patients with a documented early and late asthmatic response to
      inhaled incremental allergen challenge will be eligible for entry into Part 2 of the study.

      Part 2: Dosing and Follow-up

      Patients will be assigned to receive drug and placebo in a random order, with at least a two
      week washout between treatment periods. Spirometry, vital signs, and asthma symptomatology,
      methacholine challenge, sputum differentials will be evaluated before the first dose and
      again 24 hr before allergen challenge. Allergen challenge will be performed in the morning of
      Day 3 of dosing, post-dose, with spirometry measured until seven hr post-challenge. Sputum
      will also be induced at seven hr following the allergen challenge. Methacholine challenge and
      sputum induction will be performed 24 hr after allergen challenges. Any adverse events (AEs)
      and asthma symptoms will be evaluated at each clinic visit. A physical examination, vital
      signs, ECG, spirometry and laboratory tests will be repeated at the termination visit.
    

Intervention name(s): AIM-102, D-cyclohexylalanine-D-glutamic-glycine tripeptide; Buffered Saline
Intervention type(s): Drug; Drug
Intervention description(s): AIM-102 is supplied as an oral solution. Dose is 15 mg of AIM-102 per kg of patient weight measured on Treatment Day 1 of each treatment phase The study drug will be administered for 4 consecutive days with at least a 2 week wash-out period prior to crossing over to the alternative treatment for 4 days.; The matching placebo is an oral solution of phosphate buffered saline
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Allergen induced asthma; ATS Criteria (1)