AsthmaSCANN'AIRNCT03102749
Mechanism and Dynamics of Bronchial Hyper-reactivity to Methacholine in Distal Airway on Obese Patients With Asthma
An observational study of Asthma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
New insights of small airway contribution to asthma have been gained. Poor levels of control and recurrent exacerbations were shown to have the phenotypic counterpart of asthma with predominant small airway involvement. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Asthma
- What is being tested?
- metacholine provocation test and CT-scan low dose
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Dec 2014
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited in the respiratory department of University Hospital in Montpellier (France) from June 2012 to March 2014. All patients are asthmatics, in order to avoid any gender-related biases, investigators decided to include only women. All participants had normal range spirometry, specifically regarding forced expiratory volume.
Who may be able to join
- Female >= 18 yrs
- Asthma
- Treated with Inhaled Corticosteroid (ICS)
- normal range spirometry
Who cannot join
- Patients with other respiratory disease
- Patients with myocardial infarction (for 3 month before enrollment)
- Patients with cerebrovascular accident (for 3 month before enrollment)
- Patients with arterial aneurysm known
- Patients in pregnancy
- Patients nursing
Trial locations and contacts
1 site in 1 country.
About this study
New insights of small airway contribution to asthma have been gained. Poor levels of control and recurrent exacerbations were shown to have the phenotypic counterpart of asthma with predominant small airway involvement. Very few pathological specificities were identified at this site: mast cells infiltration was suggested as the specific inflammatory change when compared to the proximal airways.Biomarkers in asthma are still complex to validate, especially in the blood, since compartmentalisation is intense in the lung and the airways, a property attributed to the filtering role of the lung to maintain homeostasis. Over the last few years, Fraction exhaled Nitric Oxide (FENO) was developed as a non-invasive and indirect reflection of airway eosinophilic inflammation]. In the blood, peripheral eosinophil counts were shown as a correct T helper 2 (TH2)-phenotype identifier but not perfectly related to airway eosinophilic infiltration. Club cell secretory protein (SCGB1A1) levels have been shown to have some relevance in asthma, chronic obstructive pulmonary disease (COPD), BOS, sarcoidosis, and lung cancer.A biomarker for small airway disease in asthma may improve the management of the disease, identify areas of therapeutic resistance and constitute a therapeutic guidance tool. In this study, investigators aimed to assess small airway involvement in asthmatic women as far as they could. For this purpose, investigators analysed trends in air trapping by acquiring expiratory CT slices at each dose during a bronchoprovocation test with metacholine. Biomarkers were subsequently tested and confronted to clinical and demographical characteristics in their ability to predict the small airway involvement index obtained at CT.
Read the detailed description
Patients will be recruited in the respiratory department of University Hospital in Montpellier (France) from June 2012 to March 2014. All patients are asthmatics, in order to avoid any gender-related biases, investigators decided to include only women. All participants had normal range spirometry, specifically regarding forced expiratory volume. Each patient will undergo a bronchial provocation test coupled with a thoracic CT scan. Bronchial and alveolar Nitric Oxyde will also be measured, a blood sample will be obtained in order to measure biomarker concentrations, and the patients will be asked to answer the validated Asthma Control Questionnaire in order to quantify asthma control.
- Conditions
- Asthma
- Being tested
- metacholine provocation test and CT-scan low dose
- Keywords
- Airways, asthma, overweight
- Medical subject headings
- Asthma, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metacholine provocation test and CT-scan low doseOther
Investigators perform a metacholine provocation test where expiratory CT slices were acquired at each dose
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | Included patients with a BMI < 25 will be part of this group. Receives: Other: metacholine provocation test and CT-scan low dose | |
| Overweight | Included patients with a BMI >= 25 and <30 will be part of this group. Receives: Other: metacholine provocation test and CT-scan low dose | |
| Obese | Included patients with a BMI >= 30 will be part of this group. Receives: Other: metacholine provocation test and CT-scan low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inspiratory:expiratory mean lung density
Baseline versus post-methacholine challenge
Measured: 4 hours (after the enrollment)
Secondary outcomes (5)
Change in lung fractal dimension
Baseline versus post-methacholine challenge
Measured: 4 hours (after the enrollment)
Bronchial morphometry
Analysis of CT imaging
Measured: Baseline
CC10 level
Clara cell 10 kD protein levels in blood
Measured: Baseline
FeNO
Exhaled nitric oxide level
Measured: Baseline
FaNO
Alveolar nitric oxide level
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study startJun 2012
- Primary completionMar 2013
- Study completionDec 2014
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 University Hospital, MontpellierThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Responsible party
- Sponsor
- Investigators
- Arnaud BOURDIN, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102749
- Sponsor's protocol ID
- 8836
- Other IDs
- 2011-A01396-35
- Acronym
- SCANN'AIR
- Status last verified
- Jul 2019
- First submitted
- 5 Jun 2015
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism and Dynamics of Bronchial Hyper-reactivity to Methacholine in Distal Airway on Obese Patients With Asthma
- ClinicalTrials.gov ID
- NCT03102749
- Acronym / sponsor ID
- SCANN'AIR / 8836
- Conditions
- Asthma
- Keywords
- Airways, asthma, overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Study start
- Jun 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Apr 2017 (actual)
- 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.
New insights of small airway contribution to asthma have been gained. Poor levels of control and recurrent exacerbations were shown to have the phenotypic counterpart of asthma with predominant small airway involvement. Very few pathological specificities were identified at this site: mast cells infiltration was suggested as the specific inflammatory change when compared to the proximal airways.Biomarkers in asthma are still complex to validate, especially in the blood, since compartmentalisation is intense in the lung and the airways, a property attributed to the filtering role of the lung to maintain homeostasis. Over the last few years, Fraction exhaled Nitric Oxide (FENO) was developed as a non-invasive and indirect reflection of airway eosinophilic inflammation]. In the blood, peripheral eosinophil counts were shown as a correct T helper 2 (TH2)-phenotype identifier but not perfectly related to airway eosinophilic infiltration. Club cell secretory protein (SCGB1A1) levels have been shown to have some relevance in asthma, chronic obstructive pulmonary disease (COPD), BOS, sarcoidosis, and lung cancer.A biomarker for small airway disease in asthma may improve the management of the disease, identify areas of therapeutic resistance and constitute a therapeutic guidance tool. In this study, investigators aimed to assess small airway involvement in asthmatic women as far as they could. For this purpose, investigators analysed trends in air trapping by acquiring expiratory CT slices at each dose during a bronchoprovocation test with metacholine. Biomarkers were subsequently tested and confronted to clinical and demographical characteristics in their ability to predict the small airway involvement index obtained at CT.
Detailed description
Patients will be recruited in the respiratory department of University Hospital in Montpellier (France) from June 2012 to March 2014. All patients are asthmatics, in order to avoid any gender-related biases, investigators decided to include only women. All participants had normal range spirometry, specifically regarding forced expiratory volume. Each patient will undergo a bronchial provocation test coupled with a thoracic CT scan. Bronchial and alveolar Nitric Oxyde will also be measured, a blood sample will be obtained in order to measure biomarker concentrations, and the patients will be asked to answer the validated Asthma Control Questionnaire in order to quantify asthma control.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | Other: metacholine provocation test and CT-scan low doseIncluded patients with a BMI < 25 will be part of this group. |
| Overweight | – | Other: metacholine provocation test and CT-scan low doseIncluded patients with a BMI >= 25 and <30 will be part of this group. |
| Obese | – | Other: metacholine provocation test and CT-scan low doseIncluded patients with a BMI >= 30 will be part of this group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited in the respiratory department of University Hospital in Montpellier (France) from June 2012 to March 2014. All patients are asthmatics, in order to avoid any gender-related biases, investigators decided to include only women. All participants had normal range spirometry, specifically regarding forced expiratory volume.
Key inclusion criteria (4 listed)
- Female >= 18 yrs
- Asthma
- Treated with Inhaled Corticosteroid (ICS)
- normal range spirometry
Key exclusion criteria (6 listed)
- Patients with other respiratory disease
- Patients with myocardial infarction (for 3 month before enrollment)
- Patients with cerebrovascular accident (for 3 month before enrollment)
- Patients with arterial aneurysm known
- Patients in pregnancy
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 |
|---|---|---|
| metacholine provocation test and CT-scan low doseInvestigators perform a metacholine provocation test where expiratory CT slices were acquired at each dose | Other | Normal weight, Obese, Overweight |
Primary outcome
Change in inspiratory:expiratory mean lung density
Time frame: 4 hours (after the enrollment)
Baseline versus post-methacholine challenge
5 secondary outcomes
Change in lung fractal dimension
Time frame: 4 hours (after the enrollment)
Bronchial morphometry
Time frame: Baseline
CC10 level
Time frame: Baseline
FeNO
Time frame: Baseline
FaNO
Time frame: Baseline
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 5 Jul 2019.
- SCANN'AIR on the Open Science FrameworkLink provided by the sponsor.
- Derived methods publication.Link provided by the sponsor.
- Secondary results publication.Link 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.
Arnaud BOURDIN, MD principal investigator
University Hospital, Montpellier
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, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 6 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 5 Jul 2019. 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 France. 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?
Change in inspiratory:expiratory mean lung density (time frame: 4 hours (after the enrollment)). 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 5 Jul 2019.