Cystic FibrosisFLONAMUCNCT03911258
Epidemiology of the Nasal Flora at the Reference Center for Cystic Fibrosis of Queen Fabiola Children's University Hospital.
A study testing nasopharyngeal swab versus nasal wash in people with Cystic Fibrosis, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
Trial summary
Cystic fibrosis (CF) is the most common autosomal recessive inherited genetic disorder in North America, Australia and Europe. CF is due to cystic fibrosis transmembrane conductance regulator gene mutation (CFTR) coding for a chloride channel located at the apical membrane of epithelial cells. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- nasopharyngeal swab versus nasal wash
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Feb 2019to 30 Apr 2020
- 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 Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cystic fibrosis patients aged 0-20y followed in Cystic fibrosis at HUDERF
- For each participant, both parents or legally acceptable representative(s) must sign an informed consent form (ICF) indicating that they understand the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study.
- Assent is also required of children capable of understanding the study (typically participants 7 years of age and older).
Who cannot join
- Any clinical situation that prohibit the taking of samples as defined in this protocol:
- Severe respiratory distress
- An altered state of consciousness
- A pulmonary complication contrary to the realization of respiratory physiotherapy (pneumothorax, hemoptysis).
Trial locations and contacts
1 site in 1 country.
About this study
Cystic fibrosis (CF) is the most common autosomal recessive inherited genetic disorder in North America, Australia and Europe.
CF is due to cystic fibrosis transmembrane conductance regulator gene mutation (CFTR) coding for a chloride channel located at the apical membrane of epithelial cells. The most common mutation is the deletion of the amino acid phenylalanine at the codon 508 (ΔF508) affecting 70% of the patients.
Read more
The CFTR channel participates in the regulation of the volume and composition of exocrine secretions. At the level of the lungs, this results in a thickening of the mucus with a dysfunction of the mucociliary clearance promoting colonization of pathogenic microorganisms. Patients with cystic fibrosis therefore have a natural susceptibility to develop acute and then chronic respiratory infections, gradually leading to irreversible respiratory tract lesions called bronchiectasis. Different germs such as Haemophilus influenzae and Staphylococcus aureus colonize the airways early in life. The progression of the disease causes furthermore a colonization by opportunistic germs such as Pseudomonas aeruginosa and Burkholderia cepacia, which are associated with higher mortality.
Pulmonary exacerbation is a common complication of CF requiring administration of antibiotics. The choice of these antibiotics depends on the germs that the patient carries in his respiratory tract.
The type of sampling and the conditions under which they are taken are therefore very important. Sputum and oropharyngeal smear are used in adolescents and children respectively to collect respiratory secretions in clinical routine. The recent literature describes induced sputum, obtained after a physiotherapy session and a hypertonic serum aerosol, as superior to the oropharyngeal smear alone and equivalent to bronchoalveolar lavage for the evaluation of the microbiological profile of patients who cannot expectorate. However, this technique takes time and requires the presence of a physiotherapist.
Bronchoalveolar lavage is reserved for complex cases that do not respond to standard treatments.
Finally, the nasal flora appears to be involved in the colonization of the lower respiratory tract. Sinuses are described as reservoirs of germs that can induce a recolonization of the lungs despite eradication of the germ (for example after a pulmonary transplantation) .
To our knowledge, no study has investigated the involvement of nasal flora in the clinical course of children with CF.
- Conditions
- Cystic Fibrosis
- Being tested
- nasopharyngeal swab versus nasal wash
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal swab versus nasal washProcedure or surgery
The type of procedure will be determine according to patient collaboration
| Study group | Role | What they receive |
|---|---|---|
| Nasal flora in CF patient | Experimental | Not described Receives: Procedure: nasopharyngeal swab versus nasal wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance between the microbiological results obtained by nasal lavage or swab and sputum in children
To see if there is any correlation in the cultures of pathogens present in the upper and lower respiratory tracts for any combination of samples taken
Measured: Day 1
Secondary outcomes (5)
Impact of upper respiratory microbial flora in the patient clinical course
To see if there is any correlation between the presence of pathogens in upper respiratory tract (URT) and the alteration of one or more clinical parameters at the time of sampling (BMI, FEV1, FVC, FEF25/75, Number of exacerbations)
Measured: Day 60
Safety evaluation of the of the different methods of sampling
Type, frequency, severity and relationship between adverse events observed and sampling procedures performed.
Measured: Day 1
Tolerance of the different methods of sampling
Pain / discomfort score induced by the set of sampling procedures measured by means of the "Visual Analogue Scale" (VAS) in children aged 5 or older. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (0) and 'pain as bad as it could be' (10). The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: Day 1
Tolerance of the different methods of sampling
Pain / discomfort score induced by the set of sampling procedures measured by means of the FLACC scale (Face, Legs, Activity, Cry, Consolability Scale) in children less than 5 years. FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. The criteria evaluated are expression of the face, position of the legs, patient activity, type of cry, consolability
Measured: Day 1
Tolerance of the different methods of sampling
Percentage of Drop-out for refusal of nasal sampling
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start6 Feb 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe Beghin, MD, Principal investigator, Queen Fabiola Children's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911258
- Sponsor's protocol ID
- P2018/PNEUMO/FLONAMUC
- Acronym
- FLONAMUC
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of the Nasal Flora at the Reference Center for Cystic Fibrosis of Queen Fabiola Children's University Hospital.
- ClinicalTrials.gov ID
- NCT03911258
- Acronym / sponsor ID
- FLONAMUC / P2018/PNEUMO/FLONAMUC
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 11 Apr 2019 (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.
Cystic fibrosis (CF) is the most common autosomal recessive inherited genetic disorder in North America, Australia and Europe.
CF is due to cystic fibrosis transmembrane conductance regulator gene mutation (CFTR) coding for a chloride channel located at the apical membrane of epithelial cells. The most common mutation is the deletion of the amino acid phenylalanine at the codon 508 (ΔF508) affecting 70% of the patients.
The CFTR channel participates in the regulation of the volume and composition of exocrine secretions. At the level of the lungs, this results in a thickening of the mucus with a dysfunction of the mucociliary clearance promoting colonization of pathogenic microorganisms. Patients with cystic fibrosis therefore have a natural susceptibility to develop acute and then chronic respiratory infections, gradually leading to irreversible respiratory tract lesions called bronchiectasis. Different germs such as Haemophilus influenzae and Staphylococcus aureus colonize the airways early in life. The progression of the disease causes furthermore a colonization by opportunistic germs such as Pseudomonas aeruginosa and Burkholderia cepacia, which are associated with higher mortality.
Pulmonary exacerbation is a common complication of CF requiring administration of antibiotics. The choice of these antibiotics depends on the germs that the patient carries in his respiratory tract.
The type of sampling and the conditions under which they are taken are therefore very important. Sputum and oropharyngeal smear are used in adolescents and children respectively to collect respiratory secretions in clinical routine. The recent literature describes induced sputum, obtained after a physiotherapy session and a hypertonic serum aerosol, as superior to the oropharyngeal smear alone and equivalent to bronchoalveolar lavage for the evaluation of the microbiological profile of patients who cannot expectorate. However, this technique takes time and requires the presence of a physiotherapist.
Bronchoalveolar lavage is reserved for complex cases that do not respond to standard treatments.
Finally, the nasal flora appears to be involved in the colonization of the lower respiratory tract. Sinuses are described as reservoirs of germs that can induce a recolonization of the lungs despite eradication of the germ (for example after a pulmonary transplantation) .
To our knowledge, no study has investigated the involvement of nasal flora in the clinical course of children with CF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal flora in CF patient | Experimental | Procedure: nasopharyngeal swab versus nasal wash |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Cystic fibrosis patients aged 0-20y followed in Cystic fibrosis at HUDERF
- For each participant, both parents or legally acceptable representative(s) must sign an informed consent form (ICF) indicating that they understand the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study.
- Assent is also required of children capable of understanding the study (typically participants 7 years of age and older).
Key exclusion criteria (4 listed)
- Severe respiratory distress
- An altered state of consciousness
- A pulmonary complication contrary to the realization of respiratory physiotherapy (pneumothorax, hemoptysis).
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 |
|---|---|---|
| nasopharyngeal swab versus nasal washThe type of procedure will be determine according to patient collaboration | Procedure or surgery | Nasal flora in CF patient |
Primary outcome
concordance between the microbiological results obtained by nasal lavage or swab and sputum in children
Time frame: Day 1
To see if there is any correlation in the cultures of pathogens present in the upper and lower respiratory tracts for any combination of samples taken
5 secondary outcomes
Impact of upper respiratory microbial flora in the patient clinical course
Time frame: Day 60
Safety evaluation of the of the different methods of sampling
Time frame: Day 1
Tolerance of the different methods of sampling
Time frame: Day 1
Tolerance of the different methods of sampling
Time frame: Day 1
Tolerance of the different methods of sampling
Time frame: Day 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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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.
Jean-Christophe Beghin, MD principal investigator
Queen Fabiola Children's University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasopharyngeal swab versus nasal wash in people with Cystic Fibrosis, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Apr 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 Belgium. 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?
Results are not available in the source record.
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?
concordance between the microbiological results obtained by nasal lavage or swab and sputum in children (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 16 Apr 2019.