AsthmaMUCITOLLNCT02948153
Mucins and Toll-like Receptors in Asthma
An observational study of Asthma and Inflammation, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
This study raises two main hypotheses: 1) Asthmatics patients who present with bronchial hypersecretion differ phenotypically from asthmatic patients without hypersecretion and 2) mucins in asthmatic patients with hypersecretion of bronchial mucus and the expression of TLRs differ from non-mucus hypersecretory… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma, Inflammation
- What is being tested?
- clinical study
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Apr 2016
- Phase
- Observational
- 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
Study population: Male and female subjects aged > 18 years, non-smokers, who fulfilled the diagnostic criteria of asthma were consecutively enrolled from the Asthma Unit outpatient clinic of our institution. We defined asthma as a history of variable respiratory symptoms and evidence of variable expiratory airflow limitation. All patients had a positive bronchodilator test or daily peak expiratory flow variability greater than 20%, or a positive methacholine challenge test documented in case history. Asthma severity was defined according to the Global Initiative for Asthma Management (GINA)
Who may be able to join
- Non-smokers, asthma diagnosed as per the Global INitiative for Asthma (GINA) criteria on maintenance treatment for asthma, aged 18 to 80 years.
Who cannot join
- Patients were excluded from the study if they had a respiratory tract infection and/or required the use of oral corticosteroids within 30 days prior to inclusion; if they had a concomitant disease (sarcoidosis, lung cancer, pulmonary tuberculosis, bronchiectasis, nephropathy, rheumatic or liver disease); significant comorbidity that could affect the study results in the physician's judgment; or a cognitive impairment that could limit their comprehension of the subject under study or their ability to participate
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
Barcelona, Barcelona, 08041
About this study
Official title: Asthma With Bronchial Hypersecretion: Expression of Mucins and Toll-like Receptors in Sputum and Blood
This study raises two main hypotheses: 1) Asthmatics patients who present with bronchial hypersecretion differ phenotypically from asthmatic patients without hypersecretion and 2) mucins in asthmatic patients with hypersecretion of bronchial mucus and the expression of TLRs differ from non-mucus hypersecretory asthmatics patients.
Read the detailed description
Asthma with bronchial hypersecretion is a type of asthma poorly studied. Its pathogenesis is not well understood but probably is related to the innate impaired immunity, particularly with "toll-like receptors" (TLR) and secretory mucin (MUC).
Objectives 1) Define the clinical and inflammatory phenotype of asthma with bronchial hypersecretion of mucus. 2) Compare the type of mucin present in induced sputum (IS) of patients with and without bronchial hypersecretion. 3) Determine the expression of TLRs in the IS and in the peripheral blood of asthmatics with and without bronchial hypersecretion.
Method: Cross-sectional study which included 43 asthmatic patients, 19 with and 24 without bronchial hypersecretion. All patients underwent the following: IS, spirometry, fractional exhaled nitric oxide (FeNO), prick test, total IgE and blood albumin. Analysis of mucins (MUC2, MUC5AC, MUC5B and MUC1) was determined by ELISA and expression of TLR2 and TLR4 by flow cytometry. The level of asthma control was determined by the asthma control test questionnaire (ACT) and quality of life was assessed by the MiniAQLQ questionnaire.
- Conditions
- Asthma, Inflammation
- Being tested
- clinical study
- Medical subject headings
- Asthma, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical studyOther
It is a comprehensive study in a large sample using multiple techniques to assess various aspects of the disease. All patients underwent the following : Induced Sputum, spirometry, fractional exhaled nitric oxide (FeNO), prick test, total IgE and blood albumin. Analysis of mucins and TLRs
| Study group | Role | What they receive |
|---|---|---|
| asthma with bronchial hypersecretion | In a clinical study, participants are often divided into groups. Group one: they were defined as those who expectorated daily for at least three months for a minimum period of two consecutive years, without attribution to any other cause or disease. Receives: Other: clinical study | |
| asthma without hypersecretion | In a clinical study, participants are often divided into groups. Group two: We defined asthma as a history of variable respiratory symptoms and evidence of variable expiratory airflow limitation. Receives: Other: clinical study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of asthmatic patients with bronchial hypersecretion
Measured: 18 months
Secondary outcomes (2)
Number of asthmatic patients with altered expression of TLRs
Measured: 18 months
Number of asthmatic patients with altered expression of Mucins
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Respiratory Society
- Responsible party
- Sponsor
- Investigators
- Astrid Crespo, MD,PHD, Principal investigator, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948153
- Sponsor's protocol ID
- IIBSP-ROF-2011-106
- Acronym
- MUCITOLL
- Status last verified
- Sep 2015
- First submitted
- 18 Oct 2016
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma With Bronchial Hypersecretion: Expression of Mucins and Toll-like Receptors in Sputum and Blood
- ClinicalTrials.gov ID
- NCT02948153
- Acronym / sponsor ID
- MUCITOLL / IIBSP-ROF-2011-106
- Conditions
- Asthma, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Spanish Respiratory Society
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Oct 2016 (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.
This study raises two main hypotheses: 1) Asthmatics patients who present with bronchial hypersecretion differ phenotypically from asthmatic patients without hypersecretion and 2) mucins in asthmatic patients with hypersecretion of bronchial mucus and the expression of TLRs differ from non-mucus hypersecretory asthmatics patients.
Detailed description
Asthma with bronchial hypersecretion is a type of asthma poorly studied. Its pathogenesis is not well understood but probably is related to the innate impaired immunity, particularly with "toll-like receptors" (TLR) and secretory mucin (MUC).
Objectives 1) Define the clinical and inflammatory phenotype of asthma with bronchial hypersecretion of mucus. 2) Compare the type of mucin present in induced sputum (IS) of patients with and without bronchial hypersecretion. 3) Determine the expression of TLRs in the IS and in the peripheral blood of asthmatics with and without bronchial hypersecretion.
Method: Cross-sectional study which included 43 asthmatic patients, 19 with and 24 without bronchial hypersecretion. All patients underwent the following: IS, spirometry, fractional exhaled nitric oxide (FeNO), prick test, total IgE and blood albumin. Analysis of mucins (MUC2, MUC5AC, MUC5B and MUC1) was determined by ELISA and expression of TLR2 and TLR4 by flow cytometry. The level of asthma control was determined by the asthma control test questionnaire (ACT) and quality of life was assessed by the MiniAQLQ questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asthma with bronchial hypersecretion | – | Other: clinical studyIn a clinical study, participants are often divided into groups. Group one: they were defined as those who expectorated daily for at least three months for a minimum period of two consecutive years, without attribution to any other cause or disease. |
| asthma without hypersecretion | – | Other: clinical studyIn a clinical study, participants are often divided into groups. Group two: We defined asthma as a history of variable respiratory symptoms and evidence of variable expiratory airflow limitation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects aged > 18 years, non-smokers, who fulfilled the diagnostic criteria of asthma were consecutively enrolled from the Asthma Unit outpatient clinic of our institution. We defined asthma as a history of variable respiratory symptoms and evidence of variable expiratory airflow limitation. All patients had a positive bronchodilator test or daily peak expiratory flow variability greater than 20%, or a positive methacholine challenge test documented in case history. Asthma severity was defined according to the Global Initiative for Asthma Management (GINA)
Key inclusion criteria (1 listed)
- Non-smokers, asthma diagnosed as per the Global INitiative for Asthma (GINA) criteria on maintenance treatment for asthma, aged 18 to 80 years.
Key exclusion criteria (1 listed)
- Patients were excluded from the study if they had a respiratory tract infection and/or required the use of oral corticosteroids within 30 days prior to inclusion; if they had a concomitant disease (sarcoidosis, lung cancer, pulmonary tuberculosis, bronchiectasis, nephropathy, rheumatic or liver disease); significant comorbidity that could affect the study results in the physician's judgment; or a cognitive impairment that could limit their comprehension of the subject under study or their ability to participate
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 |
|---|---|---|
| clinical studyIt is a comprehensive study in a large sample using multiple techniques to assess various aspects of the disease. All patients underwent the following : Induced Sputum, spirometry, fractional exhaled nitric oxide (FeNO), prick test, total IgE and blood albumin. Analysis of mucins and TLRs | Other | asthma with bronchial hypersecretion, asthma without hypersecretion |
Primary outcome
Number of asthmatic patients with bronchial hypersecretion
Time frame: 18 months
2 secondary outcomes
Number of asthmatic patients with altered expression of TLRs
Time frame: 18 months
Number of asthmatic patients with altered expression of Mucins
Time frame: 18 months
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 28 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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, MD,PHD principal investigator
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Inflammation, 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 1 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 28 Oct 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 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?
Number of asthmatic patients with bronchial hypersecretion (time frame: 18 months). 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 28 Oct 2016.