Back to resultsComparing Efficacy and Safety of Inhaled SNG001 to Placebo
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Interferon beta 1a
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma
Eligibility Criteria
- Male or female aged 18 to 65 years of age at the time of screening.
Symptoms of asthma for at least 2 years pri or to the Screening Visit, confirmed by a medical history and:
- ≥12% and 200mL bronchodilator reversibility at screening or documented in the past, OR,
- evidence of bronchial hyper-responsiveness at screening or documented in the past, OR,
- a documented hospital admission (including an Accident and Emergency admission) for asthma since the age of 18, OR.
- 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
- Must answer "Yes" to the question "Does a cold make your asthma worse?"
- 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.
- Must be taking regular inhaled corticosteroids.
- Pre-bronchodilator FEV1 ≥ 40 % predicted at screening.
- Post-bronchodilator FEV1 ≥ 50 % predicted at screening.
- Provide written informed consent.
- 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.
- 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.
Sites / Locations
- Southampton University General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
SNG001
Arm Description
Placebo once daily for 14 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Asthma Index
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 mITT population as measured by peak score of the Asthma Index (Sorkness et al, 2008) 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
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.
Asthma Index
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).
Sever Exacerbation
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
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
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
To evaluate the safety of inhaled SNG001 when administered to asthmatic subjects.
Concomitant Medications
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
To gain information on the pharmacokinetic profile of inhaled SNG001 administered to asthmatic subjects during a respiratory virus infection.
Pharmacodynamic
To gain information on the pharmacodynamic profile of inhaled SNG001 administered to asthmatic subjects during a respiratory virus infection.
Full Information
NCT ID
NCT01126177
First Posted
May 17, 2010
Last Updated
February 10, 2012
Sponsor
Synairgen Research Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01126177
Brief Title
Comparing Efficacy and Safety of Inhaled SNG001 to Placebo
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synairgen Research Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily for 14 days
Arm Title
SNG001
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Interferon beta 1a
Intervention Description
SNG001, IFN-β1a solution for inhalation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (excipients of the SNG001 solution only)
Primary Outcome Measure Information:
Title
S-ACQ
Description
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
Time Frame
Baseline - Day 8
Secondary Outcome Measure Information:
Title
Asthma Index
Description
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 mITT population as measured by peak score of the Asthma Index (Sorkness et al, 2008) 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).
Time Frame
Day 1-14
Title
S-ACQ
Description
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.
Time Frame
Baseline - Day 8
Title
Asthma Index
Description
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).
Time Frame
14 days
Title
Sever Exacerbation
Description
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.
Time Frame
Day 1-14
Title
Lung Function
Description
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.
Time Frame
Day 1-14
Title
Viral Load
Description
To compare the effect of inhaled SNG001 to placebo when administered to asthmatic subjects on viral load on Days 4 and 7 in sputum.
Time Frame
Days 4 and 7
Title
Safety
Description
To evaluate the safety of inhaled SNG001 when administered to asthmatic subjects.
Time Frame
Day 1-14
Title
Concomitant Medications
Description
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.
Time Frame
Day 1-28
Title
Pharmacokinetic
Description
To gain information on the pharmacokinetic profile of inhaled SNG001 administered to asthmatic subjects during a respiratory virus infection.
Time Frame
Day 1-14
Title
Pharmacodynamic
Description
To gain information on the pharmacodynamic profile of inhaled SNG001 administered to asthmatic subjects during a respiratory virus infection.
Time Frame
Day 1-14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Male or female aged 18 to 65 years of age at the time of screening.
Symptoms of asthma for at least 2 years pri or to the Screening Visit, confirmed by a medical history and:
≥12% and 200mL bronchodilator reversibility at screening or documented in the past, OR,
evidence of bronchial hyper-responsiveness at screening or documented in the past, OR,
a documented hospital admission (including an Accident and Emergency admission) for asthma since the age of 18, OR.
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
Must answer "Yes" to the question "Does a cold make your asthma worse?"
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.
Must be taking regular inhaled corticosteroids.
Pre-bronchodilator FEV1 ≥ 40 % predicted at screening.
Post-bronchodilator FEV1 ≥ 50 % predicted at screening.
Provide written informed consent.
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ratko Djukanovic, MD, DM, FRCP
Organizational Affiliation
University of Southampton
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southampton University General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24937476
Citation
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.
Results Reference
derived
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Comparing Efficacy and Safety of Inhaled SNG001 to Placebo
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