Rhinovirus Infection in AsthmaNCT01773590
Mechanisms of Interplay Between Allergy and Viruses in Asthma
A study testing Rhinovirus Infection in people with Rhinovirus Infection in Asthma, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate the mechanisms of interplay between allergy (IgE and Th2 mediated inflammation) and virus infection in the development of asthma, as well as the risk and severity of acute exacerbations of asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinovirus Infection in Asthma
- What is being tested?
- Rhinovirus Infection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Jan 2016
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-55 years
- Doctor diagnosis of Asthma
- Histamine PC20 < 8 µg/ml (or <12 µg/ml and bronchodilator response ≥ 12%) and worsening asthma symptoms with infection since last change in asthma therapy
- Atopic on skin testing
- Treatment comprising ICS or combination inhaler (LABA+ICS)
- subjects on inhaled corticosteroids must be on a daily dose of 400mcg fluticasone or equivalent.
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- An Asthma Control Questionnaire (ACQ) score of > 0.75.
- Age 18-55 years
- No history or clinical diagnosis of asthma
- No history of allergic rhinitis or eczema
- Negative responses on skin prick testing
- PC20 > 8 µg/ml and bronchodilator response <12%
- Absence of current or previous history of significant respiratory disease
- Absence of significant systemic disease
Who cannot join
- Smoking history over past 6 months
- Negative skin prick tests
- Current symptoms of allergic rhinitis
- Current or previous history of significant respiratory disease (other than asthma)
- Any clinically relevant abnormality on screening or detected significant systemic disease
- Pregnant or breastfeeding women
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- Contact with infants or elderly at home or at work
- Asthma exacerbation or viral illness within the previous 6 weeks
- Treatment with oral steroids now or in the previous 3 months
- Current use of nasal spray, anti-histamine, anti-leukotrienes
- Antibodies to rhinovirus 16 in a titre >1:2
- Any clinically relevant abnormality on screening or detected significant systemic disease
- A current or previous diagnosis of asthma
- Any positive skin prick test
- Current symptoms of allergic rhinitis
- History of eczema or allergic rhinitis
- Pregnant or nursing women
- Common cold within the previous 8 weeks
- Treatment with oral or inhaled steroids now or in the previous 3 months; current use of long-acting β-agonists, nasal spray, anti-histamine, leukotrienes or tiotropium.
- Shortness of breath score at screening over 1 or total lower respiratory tract score over 7
- Antibodies to rhinovirus 16 in a titre >1:2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanisms of Interplay Between Allergy and Viruses in Asthma: A Human Model of Rhinovirus Induced Acute Asthma Exacerbations
The aim of this study is to investigate the mechanisms of interplay between allergy (IgE and Th2 mediated inflammation) and virus infection in the development of asthma, as well as the risk and severity of acute exacerbations of asthma. Understanding these mechanisms should identify new approaches for novel therapies for the prevention of asthma development and for prevention/treatment of asthma exacerbations. Such treatment has potential to have a major impact on patient quality of life and to result in enormous reductions in health care costs.
A human model will be used to identify dysregulated genes/proteins and determine relationships with disease outcomes. This study will compare lower airway responses between asthmatic and healthy control subjects undergoing rhinovirus (RV) experimental infection (subjects will be infected with rhinovirus as part of the study). This will have the dual advantage of investigating mechanisms in the most natural model possible, as well as developing a better model for testing novel therapeutic approaches. The investigators will analyse the samples from both subject groups, to determine their relevance to the human disease. Any genes/proteins shown to be dysregulated and related to disease outcomes in the human model will be very strong candidates for immediate translation into human intervention studies.
Read more
Up to 12 asthmatic and/or healthy subjects will be recruited for a preliminary pilot study. These subjects will be ineligible to enter the main study due to the presence of neutralizing antibody to RV16 (~50% of subjects otherwise suitable for the study). These subjects will meet all other inclusion/exclusion criteria for the main study. The 12 participants will undergo tests including a single bronchoscopy, nasal sampling and blood tests allowing for optimisation of all sample processing techniques. They will not be infected with RV-16.
In the main study the investigators will aim to study up to 15 healthy volunteers and 15 volunteers with moderate asthma (all on inhaled steroid treatment). Subjects will undergo a single baseline bronchoscopy 2 weeks prior to inoculation with the RV16 virus. Following infection with the virus participants will be required to attend for regular sample collection including 2 further bronchoscopies post-infection. Patients will be followed until convalescence 6 weeks post infection.
- Conditions
- Rhinovirus Infection in Asthma
- Being tested
- Rhinovirus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhinovirus InfectionOther
| Study group | Role | What they receive |
|---|---|---|
| Asthmatics | Other | Rhinovirus Infection Receives: Other: Rhinovirus Infection |
| Healthy Volunteers | Other | Rhinovirus Infection Receives: Other: Rhinovirus Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Host response to RV challenge
The host response to RV challenge will be assessed daily for 8 days using methods including symptom diaries, lung function, detection of mediators in nasal and bronchial lining fluid, characterisation of different cell types in bronchoalveolar lavage as determined by flow cytometry. This will be compared with findings at baseline, day 11, 15 and up to 42 days post challenge.
Measured: Prior to and 0-42 days post challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinovirus Infection in AsthmaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Johnston, Principal investigator, National Heart and Lung Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773590
- Sponsor's protocol ID
- 12/LO/1278
- Other IDs
- 12/LO/1278
- Status last verified
- Jan 2016
- First submitted
- 30 Nov 2012
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Interplay Between Allergy and Viruses in Asthma: A Human Model of Rhinovirus Induced Acute Asthma Exacerbations
- ClinicalTrials.gov ID
- NCT01773590
- Acronym / sponsor ID
- 12/LO/1278
- Conditions
- Rhinovirus Infection in Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the mechanisms of interplay between allergy (IgE and Th2 mediated inflammation) and virus infection in the development of asthma, as well as the risk and severity of acute exacerbations of asthma. Understanding these mechanisms should identify new approaches for novel therapies for the prevention of asthma development and for prevention/treatment of asthma exacerbations. Such treatment has potential to have a major impact on patient quality of life and to result in enormous reductions in health care costs.
A human model will be used to identify dysregulated genes/proteins and determine relationships with disease outcomes. This study will compare lower airway responses between asthmatic and healthy control subjects undergoing rhinovirus (RV) experimental infection (subjects will be infected with rhinovirus as part of the study). This will have the dual advantage of investigating mechanisms in the most natural model possible, as well as developing a better model for testing novel therapeutic approaches. The investigators will analyse the samples from both subject groups, to determine their relevance to the human disease. Any genes/proteins shown to be dysregulated and related to disease outcomes in the human model will be very strong candidates for immediate translation into human intervention studies.
Up to 12 asthmatic and/or healthy subjects will be recruited for a preliminary pilot study. These subjects will be ineligible to enter the main study due to the presence of neutralizing antibody to RV16 (~50% of subjects otherwise suitable for the study). These subjects will meet all other inclusion/exclusion criteria for the main study. The 12 participants will undergo tests including a single bronchoscopy, nasal sampling and blood tests allowing for optimisation of all sample processing techniques. They will not be infected with RV-16.
In the main study the investigators will aim to study up to 15 healthy volunteers and 15 volunteers with moderate asthma (all on inhaled steroid treatment). Subjects will undergo a single baseline bronchoscopy 2 weeks prior to inoculation with the RV16 virus. Following infection with the virus participants will be required to attend for regular sample collection including 2 further bronchoscopies post-infection. Patients will be followed until convalescence 6 weeks post infection.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthmatics | Other | Other: Rhinovirus InfectionRhinovirus Infection |
| Healthy Volunteers | Other | Other: Rhinovirus InfectionRhinovirus Infection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Age 18-55 years
- Doctor diagnosis of Asthma
- Histamine PC20 < 8 µg/ml (or <12 µg/ml and bronchodilator response ≥ 12%) and worsening asthma symptoms with infection since last change in asthma therapy
- Atopic on skin testing
- Treatment comprising ICS or combination inhaler (LABA+ICS)
Key exclusion criteria (21 listed)
- Smoking history over past 6 months
- Negative skin prick tests
- Current symptoms of allergic rhinitis
- Current or previous history of significant respiratory disease (other than asthma)
- Any clinically relevant abnormality on screening or detected significant systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhinovirus Infection | Other | Asthmatics, Healthy Volunteers |
Primary outcome
Host response to RV challenge
Time frame: Prior to and 0-42 days post challenge
The host response to RV challenge will be assessed daily for 8 days using methods including symptom diaries, lung function, detection of mediators in nasal and bronchial lining fluid, characterisation of different cell types in bronchoalveolar lavage as determined by flow cytometry. This will be compared with findings at baseline, day 11, 15 and up to 42 days post challenge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Johnston principal investigator
National Heart and Lung Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhinovirus Infection in people with Rhinovirus Infection in Asthma, run by Imperial College London 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?
The sponsor lists 14 inclusion and 21 exclusion criteria. 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 17 Feb 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Host response to RV challenge (time frame: Prior to and 0-42 days post challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2016.