To Assess the Effect of RNS60 and Budesonide in Asthmatic Patients

Phase 1

• Conditions: Asthma; MedDRA version: 18.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-003846-29-GB
• Lead Sponsor: Revalesio Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

• Male and female subjects aged 18 to 65 years inclusive;
• Subjects with a body weight =50 kg and a body mass index (BMI) between 18.0 - 32.0
• Subjects should be steroid-naïve (within 3 months of screening for oral corticosteroids and within 28 days of screening for inhaled corticosteroids), with mild asthma, but be otherwise healthy;
• Male subjects should agree to not donate sperm from first dose until 3 months post-last dose;
• Male subjects (with female partners of child bearing potential) and female subjects of child bearing potential should use two methods of highly effective contraception;
• Subjects should be non-smokers; ex-smokers must not have smoked for at least 12 months, and have smoked less than a packet of cigarettes a day for 10 years, or equivalent;
• Subjects should be taking only reliever medication for their asthma Antihistamines will be permitted up to 7 days prior to the first screening visit;
• Lung function (blowing tests) must be 70% of the predicted normal value for age, height and sex at screening and prior to first dose administration;
• Must show significant irritability of the airways when inhaling a mist of methacholine
• Documented allergy to at least one common allergen (house dust mite, grass pollen allergens or cat dander) as confirmed by a skin prick test. Historical data (up to 1 year) may be used;
• Must show significant irritability of the airways when inhaling a mist of an allergen they’re allergic to on skin prick testing.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Subjects with evidence or history of clinically significant illness (excluding mild asthma);
• Significant worsening of asthma in the 4 weeks preceding the screening visit requiring treatment above and beyond the usual preventer;
• A respiratory infection in the 4 weeks preceding the first screening visit or prior to Day 1, Period 1;
• Use of any immunotherapy within 3 months prior to first screening;
• Regular use of medications;
• Use of preventer medication for the treatment of asthma in the 4 weeks before screening is not allowed, and throughout participation in the study;
• Concomitant disease or condition that could interfere with the conduct of the study, or for which the treatment could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;
• History of life-threatening asthma;
• Nasal Symptoms of allergy requiring treatment, at screening or predicted to require treatment during the study;
• History of severe allergy;
• Clinically significant abnormalities found on physical examination or in laboratory test results;
• Subjects who have received any investigational drug in any clinical trial within 3 months, or who are on extended follow-up;
• Subjects who are vegans or have medical dietary restrictions;
• Patients who take concomitant treatment with herbal medication/supplements or St John’s Wort;
• Subjects with a supine systolic blood pressure (SBP) =160 mmHg or a supine diastolic blood pressure (DBP) =100 mmHg at screening or prior to Day 1 Period 1;
• History of alcohol abuse or drug addiction or positive alcohol test;
• Positive screen on hepatitis B, hepatitis C, or antibodies to the human immunodeficiency virus (HIV);
• Clinically significant abnormal 12-lead ECG or one demonstrating QTcF >450 ms at screening;
• Significantly abnormal liver enzymes (alanine aminotransferase [ALT] >1.5 x upper limit of normal [ULN] or total bilirubin >1.5x ULN);
• Subjects who cannot communicate reliably with the Investigator; and
• Subjects who are unlikely to co-operate with the requirements of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: To assess the effect of treatment with RNS60 on the response to allergen challenge compared to placebo (0.9% saline) in subjects with mild asthma.<br> To assess the safety and tolerability of multiple doses of RNS60 in subjects with mild asthma.<br> ;Secondary Objective: Not applicable;<br> Primary end point(s): Emax(3-8): The maximal percentage decrease<br> from the pre-allergen challenge (post-diluentvalue) in FEV1 during 3 hours to 8 hours post- allergen challenge.<br> ;Timepoint(s) of evaluation of this end point: 21 Days (please see protocol)