Comparing Efficacy and Safety of Inhaled SNG001 to Placebo

NCT ID: NCT01126177

Last Updated: 2012-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-01-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo once daily for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (excipients of the SNG001 solution only)

SNG001

Group Type: EXPERIMENTAL

Interferon beta 1a

Intervention Type: DRUG

SNG001, IFN-β1a solution for inhalation

Interventions

Interferon beta 1a

SNG001, IFN-β1a solution for inhalation

Intervention Type: DRUG

Placebo

Placebo (excipients of the SNG001 solution only)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female aged 18 to 65 years of age at the time of screening.

2. Symptoms of asthma for at least 2 years pri or to the Screening Visit, confirmed by a medical history and:

1. ≥12% and 200mL bronchodilator reversibility at screening or documented in the past, OR,

2. evidence of bronchial hyper-responsiveness at screening or documented in the past, OR,

3. a documented hospital admission (including an Accident and Emergency admission) for asthma since the age of 18, OR.

4. documented evidence that they have attended their GP surgery, out-of-hours clinic (or alternative health care provider) for worsening of asthma symptoms, since the age of 18

3. Must answer "Yes" to the question "Does a cold make your asthma worse?"

4. To have had at least one asthma exacerbation suspected to have been caused by a respiratory virus in the last 24 months which required the use of oral steroids and/or additional treatment with antibiotics on one or more occasion.

5. Must be taking regular inhaled corticosteroids.

6. Pre-bronchodilator FEV1 ≥ 40 % predicted at screening.

7. Post-bronchodilator FEV1 ≥ 50 % predicted at screening.

8. Provide written informed consent.

9. Females of childbearing potential must be using a medically acceptable adequate form of birth control and agree to maintain this usage throughout the duration of and four weeks post the Treatment Phase of the study.

10. Motivation (in the Investigator"s opinion) to complete all study visits, the ability to communicate well with the Investigator and be capable of understanding the nature of the research and its treatment including its risks and benefits.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synairgen Research Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ratko Djukanovic, MD, DM, FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Southampton

Locations

Southampton University General Hospital

Southampton, Hampshire, United Kingdom

Countries

United Kingdom

References

Djukanovic R, Harrison T, Johnston SL, Gabbay F, Wark P, Thomson NC, Niven R, Singh D, Reddel HK, Davies DE, Marsden R, Boxall C, Dudley S, Plagnol V, Holgate ST, Monk P; INTERCIA Study Group. The effect of inhaled IFN-beta on worsening of asthma symptoms caused by viral infections. A randomized trial. Am J Respir Crit Care Med. 2014 Jul 15;190(2):145-54. doi: 10.1164/rccm.201312-2235OC.

Reference Type: DERIVED

PMID: 24937476 (View on PubMed)

Other Identifiers

SG005

Identifier Type: -

Identifier Source: org_study_id