AsthmaCAVASTHMENCT02809560
Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children
A study testing Induced sputum method using hypertonic serum in people with Asthma, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Asthma affects about 10% of children and 6% of adults in industrialized countries. Lymphocytes (L) Th2, a T cell population (LT) producing interleukin (IL) -4, 5 and 13 are broadly involved in this pathology in experimental models and in humans. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Induced sputum method using hypertonic serum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to May 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For Asthmatic children arm :
- Girl not in childbearing potential or taking contraceptive treatment
- Asthma diagnosis in at least 6 months as defined by clinical symptoms (expiratory dyspnea, wheezing, sibilance) and respiratory function (reversibility of VEMS at least 12% after salbutamol administration)
- Allergologic tests positives to airborne allergens : positive prick test and/or specific IgE > 0,35 kU/L for at least one allergen
- Asthma severity between mild to moderate based on Global initiative for asthma classification during more than one month with inhaled corticotherapies +/- long term action beta -mimetic long compounds (salmeterol, formoterol)
- Patient insured with a social security scheme
Show all 10Show fewer
- For control children arm :
- Girl not in childbearing potential or taking contraceptive treatment
- No medical history of asthma
- No medical history of allergy or symptoms of allergy on skin (atopic dermatitis), respiratory tract (rhino-conjunctivitis, asthma) or food allergy
Who cannot join
- For both arms:
- Chronic respiratory pathology : known occlusive or restrictive respiratory syndrome like interstitial lung disease, neuromuscular disease, mucoviscidoses, respiratory tract abnormalities with cough, dyspnea or digital hippocratism.
- History of pulmonary or nose and throat infectious disease during last 4 months
- Parasitic disease non treated during last 3 months
- Dyspnea during the inclusion
- Systemic corticotherapy during the last 3 months before inclusion
Show all 16Show fewer
- Immunosuppressive therapy during the last 3 months before inclusion
- Diabeta
- Disease causing immune disorder
- Infection during inclusion
- Participation to another study witch implies medical treatment during last 3 months before inclusion
- For asthmatic children arm :
- Chronic pulmonary pathology (excluding asthma)
- Asthma exacerbation during inclusion
- VEMS < 70% of normal range or VEMS < 70% of normal range after inhalation of serum (despite salbutamol administration)
- Patient unable to complete pulmonary function testing
Trial locations and contacts
1 site in 1 country.
About this study
Asthma affects about 10% of children and 6% of adults in industrialized countries. Lymphocytes (L) Th2, a T cell population (LT) producing interleukin (IL) -4, 5 and 13 are broadly involved in this pathology in experimental models and in humans. Many studies show that the signaling pathways activated by the commitment of T receiver differ depending LT. The identification of specific signaling pathways links to Th2 offer new therapeutic approaches. Precedent study showed that mouse Th2 selectively expressed related to calcium channels sensitive channels Cav1 voltage, normally found in excitable cells where they are defined as receivers dihydropyridine (DHP).
The goal of the present study is to show the presence of Cav1 channels in inflammatory cells in allergic asthmatics and show overexpression of these channels in the peripheral blood mononuclear cells from asthmatic subjects before and / or after stimulation with the TCR in comparison with controls.
- Conditions
- Asthma
- Being tested
- Induced sputum method using hypertonic serum
- Keywords
- Lymphocytes Th2, Cav1 channels
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced sputum method using hypertonic serumProcedure or surgery
Collection of expectoration in sterile vial, conserved in ice all along the examination
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic children | Experimental | Induced sputum method using hypertonic serum Receives: Procedure: Induced sputum method using hypertonic serum |
| Control children | Sham comparator | Induced sputum method using hypertonic serum Receives: Procedure: Induced sputum method using hypertonic serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of sequence coding for Cav1 in cells as assessed by reverse transcription polymerase chain reaction
Measured: Day 1
Secondary outcomes (5)
Presence of Cav1 channels as assessed by correlation between Cav1 expression and eosinophils in expectoration collection
Measured: Day 1
Presence of Cav1 channels as assessed by correlation between Cav1 expression and lymphocytes T in expectoration collection
Measured: Day 1
Comparison of CRTH2+ cells in total blood between asthmatic and control group
Measured: Day 1
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group before T-Cell receptor stimulation
Measured: Day 1
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group after T-Cell receptor stimulation
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startMar 2013
- Primary completionMay 2016
- Study completionMay 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 University Hospital, ToulouseThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Brémont, MD, Principal investigator, Hôpital des Enfants CHU Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809560
- Sponsor's protocol ID
- 11 054 03
- Acronym
- CAVASTHME
- Status last verified
- Sep 2026
- First submitted
- 17 May 2016
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children
- ClinicalTrials.gov ID
- NCT02809560
- Acronym / sponsor ID
- CAVASTHME / 11 054 03
- Conditions
- Asthma
- Keywords
- Lymphocytes Th2, Cav1 channels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Jun 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.
Asthma affects about 10% of children and 6% of adults in industrialized countries. Lymphocytes (L) Th2, a T cell population (LT) producing interleukin (IL) -4, 5 and 13 are broadly involved in this pathology in experimental models and in humans. Many studies show that the signaling pathways activated by the commitment of T receiver differ depending LT. The identification of specific signaling pathways links to Th2 offer new therapeutic approaches. Precedent study showed that mouse Th2 selectively expressed related to calcium channels sensitive channels Cav1 voltage, normally found in excitable cells where they are defined as receivers dihydropyridine (DHP).
The goal of the present study is to show the presence of Cav1 channels in inflammatory cells in allergic asthmatics and show overexpression of these channels in the peripheral blood mononuclear cells from asthmatic subjects before and / or after stimulation with the TCR in comparison with controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthmatic children | Experimental | Procedure: Induced sputum method using hypertonic serumInduced sputum method using hypertonic serum |
| Control children | Sham comparator | Procedure: Induced sputum method using hypertonic serumInduced sputum method using hypertonic serum |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Girl not in childbearing potential or taking contraceptive treatment
- Asthma diagnosis in at least 6 months as defined by clinical symptoms (expiratory dyspnea, wheezing, sibilance) and respiratory function (reversibility of VEMS at least 12% after salbutamol administration)
- Allergologic tests positives to airborne allergens : positive prick test and/or specific IgE > 0,35 kU/L for at least one allergen
- Asthma severity between mild to moderate based on Global initiative for asthma classification during more than one month with inhaled corticotherapies +/- long term action beta -mimetic long compounds (salmeterol, formoterol)
- Patient insured with a social security scheme
Key exclusion criteria (16 listed)
- Chronic respiratory pathology : known occlusive or restrictive respiratory syndrome like interstitial lung disease, neuromuscular disease, mucoviscidoses, respiratory tract abnormalities with cough, dyspnea or digital hippocratism.
- History of pulmonary or nose and throat infectious disease during last 4 months
- Parasitic disease non treated during last 3 months
- Dyspnea during the inclusion
- Systemic corticotherapy during the last 3 months before inclusion
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 |
|---|---|---|
| Induced sputum method using hypertonic serumCollection of expectoration in sterile vial, conserved in ice all along the examination | Procedure or surgery | Asthmatic children, Control children |
Primary outcome
Detection of sequence coding for Cav1 in cells as assessed by reverse transcription polymerase chain reaction
Time frame: Day 1
5 secondary outcomes
Presence of Cav1 channels as assessed by correlation between Cav1 expression and eosinophils in expectoration collection
Time frame: Day 1
Presence of Cav1 channels as assessed by correlation between Cav1 expression and lymphocytes T in expectoration collection
Time frame: Day 1
Comparison of CRTH2+ cells in total blood between asthmatic and control group
Time frame: Day 1
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group before T-Cell receptor stimulation
Time frame: Day 1
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group after T-Cell receptor stimulation
Time frame: Day 1
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 21 Sep 2026.
- Individual participant dataSharing planned: No
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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.
François Brémont, MD principal investigator
Hôpital des Enfants CHU Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induced sputum method using hypertonic serum in people with Asthma, run by University Hospital, Toulouse 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 10 inclusion and 16 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 21 Sep 2026. 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. 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.
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?
Detection of sequence coding for Cav1 in cells as assessed by reverse transcription polymerase chain reaction (time frame: Day 1). 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 21 Sep 2026.