AsthmaNCT02028637
Expression of Toll-Like Receptors 2 and 4 in Asthmatic Patients.
A study testing TLRs in people with Asthma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Introduction: Recently it has involved the role of TLR (toll-like receptors) in the pathogenesis of asthma. TLRs are a family of proteins responsible for the recognition of Pathogen-Associated Molecular Patters (PAMPs). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- TLRs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2009to Sep 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with persistent asthma (defined as per the Global INitiative for Asthma Management (GINA) criteria)
Who cannot join
- If they had a respiratory tract infection or asthma exacerbation within 30 days prior to inclusion
- If they were receiving oral steroids or immunosuppressive treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: Recently it has involved the role of TLR (toll-like receptors) in the pathogenesis of asthma. TLRs are a family of proteins responsible for the recognition of Pathogen-Associated Molecular Patters (PAMPs). The possible role that TLRs play in IgE-dependent asthma (not eosinophilic) and its recognition as a new endotype asthma, could open new therapeutic expectations.
Objective: To analyze the expression of TLR 2 and 4 in monocytes/ macrophages and neutrophils in peripheral blood and induced sputum from asthmatic patients
Read the detailed description
The investigators studied patients with asthma. All patients underwent the same day an induced sputum, pulmonary function studies, fractional exhaled nitric oxide, blood total IgE and skin test by prick technique. Asthmatic patients were classified according to the criteria of the GINA 2012. The cellular composition was analyzed by flow cytometry. Expression of TLR2 and TLR4 were analyzed using monoclonal antibodies conjugated with fluorochromes appropriate.
- Conditions
- Asthma
- Being tested
- TLRs
- Keywords
- asthma, toll like receptor, innate immunity
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLRsOther
Recently it has involved the role of TLR (toll-like receptors) in the pathogenesis of asthma.The possible role that TLRs play in the asthma and its recognition as a new endotype asthma, could open new therapeutic expectations.
| Study group | Role | What they receive |
|---|---|---|
| toll like receptor (TLRs) | Experimental | TLRs are a family of proteins responsible for the recognition of Pathogen-Associated Molecular Patters Receives: Other: TLRs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of neutrophils expressing TLR4 in induced sputum decreases in asthma not eosinophilic
The percentage of neutrophils expressing TLR4 in induced sputum decreases in asthma not eosinophilic (IgEnodep).This could suggest that in this type of asthma the defense mechanism of neutrophils could be altered by decreasing expression of these receptors on their cell surface. This mechanism would still be defined. Probably the respiratory infections play an important role.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJul 2009
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Astrid Crespo, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Investigators
- Astrid Crespo, Principal investigator, Department of Respiratory Medicine, Hospital de la Santa Creu i Sant Pau. Institut d'Investigació Biomédica Sant Pau (IIB Sant Pau). Universitat Autònoma de Barcelona, Department of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028637
- Sponsor's protocol ID
- 43/2009
- Status last verified
- Jan 2014
- First submitted
- 3 Jan 2014
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
The ENFUMOSA cross-sectional European multicentre study of the clinical phenotype of chronic severe asthma. European Network for Understanding Mechanisms of Severe Asthma. Eur Respir J. 2003 Sep;22(3):470-7. doi: 10.1183/09031936.03.00261903.
PubMed 14516137Anderson GP. Endotyping asthma: new insights into key pathogenic mechanisms in a complex, heterogeneous disease. Lancet. 2008 Sep 20;372(9643):1107-19. doi: 10.1016/S0140-6736(08)61452-X.
PubMed 18805339Weiss ST. Eat dirt--the hygiene hypothesis and allergic diseases. N Engl J Med. 2002 Sep 19;347(12):930-1. doi: 10.1056/NEJMe020092. No abstract available.
PubMed 12239263Gon Y. Toll-like receptors and airway inflammation. Allergol Int. 2008 Mar;57(1):33-7. doi: 10.2332/allergolint.R-07-157. Epub 2008 Mar 1.
PubMed 18209505Simpson JL, Grissell TV, Douwes J, Scott RJ, Boyle MJ, Gibson PG. Innate immune activation in neutrophilic asthma and bronchiectasis. Thorax. 2007 Mar;62(3):211-8. doi: 10.1136/thx.2006.061358. Epub 2006 Jul 14.
PubMed 16844729Crespo-Lessmann A, Juarez-Rubio C, Plaza-Moral V. [Role of toll-like receptors in respiratory diseases]. Arch Bronconeumol. 2010 Mar;46(3):135-42. doi: 10.1016/j.arbres.2009.07.011. Epub 2009 Sep 17.
PubMed 19765883Vidal S, Bellido-Casado J, Granel C, Crespo A, Plaza V, Juarez C. Flow cytometry analysis of leukocytes in induced sputum from asthmatic patients. Immunobiology. 2012 Jul;217(7):692-7. doi: 10.1016/j.imbio.2011.11.008. Epub 2011 Dec 2.
PubMed 22204819
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Toll-Like Receptors 2 and 4 in Asthmatic Patients.
- ClinicalTrials.gov ID
- NCT02028637
- Acronym / sponsor ID
- 43/2009
- Conditions
- Asthma
- Keywords
- asthma, toll like receptor, innate immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Jan 2014 (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.
Introduction: Recently it has involved the role of TLR (toll-like receptors) in the pathogenesis of asthma. TLRs are a family of proteins responsible for the recognition of Pathogen-Associated Molecular Patters (PAMPs). The possible role that TLRs play in IgE-dependent asthma (not eosinophilic) and its recognition as a new endotype asthma, could open new therapeutic expectations.
Objective: To analyze the expression of TLR 2 and 4 in monocytes/ macrophages and neutrophils in peripheral blood and induced sputum from asthmatic patients
Detailed description
The investigators studied patients with asthma. All patients underwent the same day an induced sputum, pulmonary function studies, fractional exhaled nitric oxide, blood total IgE and skin test by prick technique. Asthmatic patients were classified according to the criteria of the GINA 2012. The cellular composition was analyzed by flow cytometry. Expression of TLR2 and TLR4 were analyzed using monoclonal antibodies conjugated with fluorochromes appropriate.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| toll like receptor (TLRs) | Experimental | Other: TLRsTLRs are a family of proteins responsible for the recognition of Pathogen-Associated Molecular Patters |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with persistent asthma (defined as per the Global INitiative for Asthma Management (GINA) criteria)
Key exclusion criteria (2 listed)
- If they had a respiratory tract infection or asthma exacerbation within 30 days prior to inclusion
- If they were receiving oral steroids or immunosuppressive treatments.
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 |
|---|---|---|
| TLRsRecently it has involved the role of TLR (toll-like receptors) in the pathogenesis of asthma.The possible role that TLRs play in the asthma and its recognition as a new endotype asthma, could open new therapeutic expectations. | Other | toll like receptor (TLRs) |
Primary outcome
The percentage of neutrophils expressing TLR4 in induced sputum decreases in asthma not eosinophilic
Time frame: 2 years
The percentage of neutrophils expressing TLR4 in induced sputum decreases in asthma not eosinophilic (IgEnodep).This could suggest that in this type of asthma the defense mechanism of neutrophils could be altered by decreasing expression of these receptors on their cell surface. This mechanism would still be defined. Probably the respiratory infections play an important role.
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 7 Jan 2014.
- Background: PubMed 14516137The ENFUMOSA cross-sectional European multicentre study of the clinical phenotype of chronic severe asthma. European Network for Understanding Mechanisms of Severe Asthma. Eur Respir J. 2003 Sep;22(3):470-7. doi: 10.1183/09031936.03.00261903.
- Background: PubMed 18805339Anderson GP. Endotyping asthma: new insights into key pathogenic mechanisms in a complex, heterogeneous disease. Lancet. 2008 Sep 20;372(9643):1107-19. doi: 10.1016/S0140-6736(08)61452-X.
- Background: PubMed 12239263Weiss ST. Eat dirt--the hygiene hypothesis and allergic diseases. N Engl J Med. 2002 Sep 19;347(12):930-1. doi: 10.1056/NEJMe020092. No abstract available.
- Background: PubMed 18209505Gon Y. Toll-like receptors and airway inflammation. Allergol Int. 2008 Mar;57(1):33-7. doi: 10.2332/allergolint.R-07-157. Epub 2008 Mar 1.
- Background: PubMed 16844729Simpson JL, Grissell TV, Douwes J, Scott RJ, Boyle MJ, Gibson PG. Innate immune activation in neutrophilic asthma and bronchiectasis. Thorax. 2007 Mar;62(3):211-8. doi: 10.1136/thx.2006.061358. Epub 2006 Jul 14.
- Background: PubMed 19765883Crespo-Lessmann A, Juarez-Rubio C, Plaza-Moral V. [Role of toll-like receptors in respiratory diseases]. Arch Bronconeumol. 2010 Mar;46(3):135-42. doi: 10.1016/j.arbres.2009.07.011. Epub 2009 Sep 17.
- Background: PubMed 22204819Vidal S, Bellido-Casado J, Granel C, Crespo A, Plaza V, Juarez C. Flow cytometry analysis of leukocytes in induced sputum from asthmatic patients. Immunobiology. 2012 Jul;217(7):692-7. doi: 10.1016/j.imbio.2011.11.008. Epub 2011 Dec 2.
- AsthmaLink provided by the sponsor.
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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.
Astrid Crespo principal investigator
Department of Respiratory Medicine, Hospital de la Santa Creu i Sant Pau. Institut d'Investigació Biomédica Sant Pau (IIB Sant Pau). Universitat Autònoma de Barcelona, Department of Medicine.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLRs in people with Asthma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 1 inclusion and 2 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 7 Jan 2014. 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 Spain. 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?
The percentage of neutrophils expressing TLR4 in induced sputum decreases in asthma not eosinophilic (time frame: 2 years). 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 NCT02028637, which also lists 7 linked publications.
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 7 Jan 2014.