Comparing Efficacy and Safety of Inhaled SNG001 to Placebo

NCT01126177 | Completed Phase 2 DMC

• 1 other identifier: SG005
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

• S-ACQ

  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

  Baseline - Day 8

Secondary Outcomes (10)

• Asthma Index

  Day 1-14

• S-ACQ

  Baseline - Day 8

• Asthma Index

  14 days

• Sever Exacerbation

  Day 1-14

• Lung Function

  Day 1-14

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo once daily for 14 days

Drug: Placebo

SNG001

EXPERIMENTAL

Drug: Interferon beta 1a

Interventions

Interferon beta 1a DRUG

SNG001, IFN-β1a solution for inhalation

SNG001

Placebo DRUG

Placebo (excipients of the SNG001 solution only)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Synairgen Research Ltd.: lead

Study Sites (1)

Southampton University General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24937476 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ratko Djukanovic, MD, DM, FRCP

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: February 13, 2012

Record last verified: 2012-02

Locations

GB (1)