NCT01126177

Comparing Efficacy and Safety of Inhaled SNG001 to Placebo

A Randomised, Double-blind, Placebo-controlled Phase II Study, Comparing the Efficacy and Safety of Inhaled SNG001 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Synairgen Research Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Interferon beta 1a	SNG001, IFN-β1a solution for inhalation
DRUG	Placebo	Placebo (excipients of the SNG001 solution only)

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-10-01
• Completion: 2012-01-01
• First posted: 2010-05-19
• Last updated: 2012-02-13

Locations

1 site across 1 country: United Kingdom