Pilot Study of RNS60 in Allergen-induced Bronchoconstriction

Phase 2

Withdrawn

• Conditions: Asthma
• Interventions: Drug: Normal Saline; Drug: RNS60

• Registration Number: NCT02497222
• Lead Sponsor: Revalesio Corporation

Brief Summary

This study evaluates the use of RNS60 in the treatment of asthma examining regional improvements in inflammation using PET imaging. All subjects will be treated with both RNS60 and placebo in a crossover design.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-10
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-14
• Primary Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Males or females with mild asthma (as defined by the National Institutes of Health 2002 Guidelines for the Diagnosis and Management of Asthma (2)) with symptoms more than 2 times a week but less than once per day with normal FEV1 (> 80% predicted).
• Clinical history of allergic symptoms to cat or dust mite allergen and demonstrated skin reactivity.
• Subjects must have a lifetime total of less than 5 pack years with no smoking in the previous 5 years.
• Willing and able to give informed consent and adhere to the study protocol requirements.
• Expressed the desire to participate in the study in an interview with the principal investigator (PI).
• Age between 18 and 50 years.

Exclusion Criteria

• Women of childbearing potential who are documented to be pregnant (based on blood beta-human chorionic gonadotropin [HCG] testing) or who are nursing.
• The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract infection within the previous 6 weeks.
• Participation in research study involving a drug or biologic during the 30 days prior to the study.
• Intolerance to albuterol, atropine, or lidocaine.
• Antihistamines within 7 days of the screening visit.
• Known exposure to agents that are associated with pulmonary disease (i.e. asbestos, silica).
• Presence of other known pulmonary disease, coronary disease, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure (or creatinine > 1.5, if known), history of anaphylaxis, cirrhosis, diabetes mellitus or presence of a significant disease, which in the opinion of the PI would pose a significant risk for the subject or confound the results of the study.
• Use of systemic steroids, increased use of inhaled steroids, use of beta blockers and monoamine oxidase (MAO) inhibitors or a visit for an asthma exacerbation within 1 month of the screening visit.
• A history of asthma-related respiratory failure requiring intubation.
• A history of hospitalization for asthma.
• Subjects with a high possibility of poor compliance with the study as judged by the PI.
• Unresponsive to bronchodilator agents.
• Quantitative skin prick test at or below a dilution level of standardized cat allergen extract of 1:2048 (4.88 BAU/ml) for subjects being challenged with cat allergen.
• Quantitative skin prick test at or below a dilution level of standardized mite allergen extract of 1:2048 (4.88 AU/ml) for subjects being challenged with either mite allergen.
• Subjects who, by participating in any research study, will have a cumulative radiation dose exceeding 50 mSv in the previous year.
• Contraindication to Methacholine challenge testing (heart attack or stroke in last 3 months, uncontrolled hypertension, or known aortic aneurysm).
• Body Mass Index (BMI) > 32.
• Individuals with known allergy or hypersensitivity to FDG will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	Normal Saline 4 ml, inhaled twice daily by nebulization for 21 days.
RNS60	RNS60	RNS60 4 ml, inhaled twice daily by nebulization for 21 days.

Primary Outcome Measures

Name	Time	Method
18F-FDG uptake rate	21 days	Comparison of fluorodeoxyglucose (18F-FDG) uptake rate in subjects before and after inhalation of RNS60 or placebo

Secondary Outcome Measures

Name	Time	Method
Regional VA and Vdef volume	21 days	Comparison of regional ventilation (VA) and ventilation defective areas (Vdef) volume in subjects before and after inhalation of RNS60 or placebo

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States