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AsthmaPhase 2NCT01126177

Comparing Efficacy and Safety of Inhaled SNG001 to Placebo

A Phase 2 study testing Interferon beta 1a in people with Asthma, run by Synairgen Research Ltd. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma
What is being tested?
Interferon beta 1a
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2010to Jan 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  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:
  3. ≥12% and 200mL bronchodilator reversibility at screening or documented in the past, OR,
  4. evidence of bronchial hyper-responsiveness at screening or documented in the past, OR,
  5. a documented hospital admission (including an Accident and Emergency admission) for asthma since the age of 18, OR.
  6. 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
  7. Must answer "Yes" to the question "Does a cold make your asthma worse?"
  8. 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.
  9. Must be taking regular inhaled corticosteroids.
  10. Pre-bronchodilator FEV1 ≥ 40 % predicted at screening.
  11. Post-bronchodilator FEV1 ≥ 50 % predicted at screening.
  12. Provide written informed consent.
  13. 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.
  14. 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Southampton University General Hospital

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

About this study

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

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.

Read the 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
Being tested
Interferon beta 1a, Placebo
Keywords
asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interferon beta 1aDrug

    SNG001, IFN-β1a solution for inhalation

  • PlaceboDrug

    Placebo (excipients of the SNG001 solution only)

Study groups in NCT01126177
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo once daily for 14 days
Receives: Drug: Placebo
SNG001ExperimentalNot described
Receives: Drug: Interferon beta 1a

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline - Day 8

Secondary outcomes (10)

  1. 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).

    Measured: Day 1-14

  2. 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.

    Measured: Baseline - Day 8

  3. 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).

    Measured: 14 days

  4. 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.

    Measured: Day 1-14

  5. 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.

    Measured: Day 1-14

  6. 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.

    Measured: Days 4 and 7

  7. Safety

    To evaluate the safety of inhaled SNG001 when administered to asthmatic subjects.

    Measured: Day 1-14

  8. 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.

    Measured: Day 1-28

  9. Pharmacokinetic

    To gain information on the pharmacokinetic profile of inhaled SNG001 administered to asthmatic subjects during a respiratory virus infection.

    Measured: Day 1-14

  10. Pharmacodynamic

    To gain information on the pharmacodynamic profile of inhaled SNG001 administered to asthmatic subjects during a respiratory virus infection.

    Measured: Day 1-14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionOct 2011
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01126177
Sponsor's protocol ID
SG005
Status last verified
Feb 2012
First submitted
17 May 2010
Last updated
13 Feb 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24937476

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Interferon beta 1a in people with Asthma, run by Synairgen Research Ltd. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

S-ACQ (time frame: Baseline - Day 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01126177, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2012.

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