Comparing Efficacy and Safety of Inhaled SNG001 to Placebo

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: Interferon beta 1a

• Registration Number: NCT01126177
• Lead Sponsor: Synairgen Research Ltd.

Brief Summary

When people with asthma get respiratory virus such as a cold or flu it often increases asthma symptoms. The investigators will test the study medication to find out if it can prevent the virus spreading from the nose to the lungs.

SNG001 contains Interferon-beta that occurs naturally in the body. In this study, SNG001 will be given by a nebuliser.

Detailed Description

The study will consist of a Pre-Treatment Phase into which subjects potentially eligible for the Treatment Phase will be recruited. Subjects will remain in the Pre-Treatment Phase until they experience respiratory virus symptoms at which time they will be further screened for eligibility for entry into the Treatment Phase. If eligible, subjects will be randomised 1:1 to receive SNG001 or placebo once daily for 14 days. Doses will be delivered by a CE marked breath actuated nebuliser (I-neb Philips Respironics). Subjects will be assessed for changes in changes in respiratory virus symptoms and asthma symptoms at home using a text message system, and via telephone questionnaire. Lung function will be measured both at home by the subjects (PEFR only) and in the clinic. Efficacy and safety will be monitored until at least 30 days post treatment.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Primary Completion: 2011-10
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-10
• Last Update Posted: 2012-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo once daily for 14 days
SNG001	Interferon beta 1a	-

Primary Outcome Measures

Name	Time	Method
S-ACQ	Baseline - Day 8	To evaluate the superiority of inhaled SNG001 compared to placebo administered to asthmatic subjects after the onset of a respiratory viral infection for the prevention or attenuation of asthma symptoms caused by respiratory viruses in the modified intention to treat (mITT) population as measured by change from Baseline to Day 8 in the Shortened-Asthma Control Questionnaire (symptoms plus short-acting β2 agonist.; - change from Baseline to Day 8 in the Shortened-Asthma Control Questionnaire

Secondary Outcome Measures

Name	Time	Method
Asthma Index	14 days	To evaluate the superiority of inhaled SNG001 compared to placebo administered to asthmatic subjects after the onset of a respiratory viral infection for the prevention or attenuation of asthma symptoms caused by respiratory viruses in the PP population as measured by peak score of the Asthma Index in the 14 day period following first administration of study drug (measured from 24 hours post first dose to 24 hours post last dose taken).
S-ACQ	Baseline - Day 8	To evaluate the superiority of inhaled SNG001 compared to placebo administered to asthmatic subjects after the onset of a respiratory viral infection for the prevention or attenuation of asthma symptoms caused by respiratory viruses in the per protocol (PP) population as measured by change from Baseline to Day 8 in the Shortened-Asthma Control Questionnaire.
Sever Exacerbation	Day 1-14	To evaluate the superiority of inhaled SNG001 compared to placebo administered to asthmatic subjects after the onset of a respiratory viral infection for the prevention or attenuation of asthma symptoms caused by respiratory viruses as measured by the proportion of subjects experiencing a severe exacerbation (Appendix 2) in the mITT population during the 14 days following first administration of study drug.
Lung Function	Day 1-14	To compare inhaled SNG001 to placebo administered to asthmatic subjects after the onset of a respiratory viral infection for the prevention or attenuation of decreases in lung function (AUC FEV1 and PEFR) caused by respiratory viruses in the mITT population during the 14 day dosing period.
Viral Load	Days 4 and 7	To compare the effect of inhaled SNG001 to placebo when administered to asthmatic subjects on viral load on Days 4 and 7 in sputum.
Safety	Day 1-14	To evaluate the safety of inhaled SNG001 when administered to asthmatic subjects.
Concomitant Medications	Day 1-28	To compare the frequency of use of concomitant medications in relation to conditions of the respiratory tract during the study Treatment Phase in asthmatic subjects receiving inhaled SNG001 compared to placebo.
Pharmacokinetic	Day 1-14	To gain information on the pharmacokinetic profile of inhaled SNG001 administered to asthmatic subjects during a respiratory virus infection.
Pharmacodynamic	Day 1-14	To gain information on the pharmacodynamic profile of inhaled SNG001 administered to asthmatic subjects during a respiratory virus infection.

Trial Locations

Locations (1)

Southampton University General Hospital; 🇬🇧 Southampton, Hampshire, United Kingdom