Cystic Fibrosis in ChildrenSPIROMUCONCT04837911
Use of a Portable Spirometer in Pediatric Patients With Cystic Fibrosis at the Nancy CHRU: Feasibility Study
A study testing Spirobank Smart in people with Cystic Fibrosis in Children, run by Central Hospital, Nancy, France.
Trial summary
Respiratory diseases (asthma, cystic fibrosis, COPD…) need for the diagnosis and the follow-up the use of pulmonary function tests. These technics which are used since the nineteenth century and their discovery by Hutchinson, are now currently performed in pediatrics hospitals but they require trained personnel. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- Spirobank Smart
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Apr 2022
- 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 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with a cystic fibrosis diagnosis confirmed by a sweat chloride measurement ≥ 60 mmol/L
- Age between 10 and 20 years at enrolment
- Able to perform spirometry
- Having a smartphone
- Written consent adapted to the age
- Affiliated with a social insurance
Who cannot join
- Antibiotic therapy for a pulmonary exacerbation in the 2 weeks before enrollment
- Lung transplantation (past or future)
- Colonization with Bulkholderia cepacia in the last 2 years
- Absence of contentment
- Inability to access technology required to transmit home spirometry data
- Inability to speak and read French well enough to understand the use of the home spirometry and to complete the questionaries
Trial locations and contacts
No sites are listed yet.
About this study
Respiratory diseases (asthma, cystic fibrosis, COPD…) need for the diagnosis and the follow-up the use of pulmonary function tests. These technics which are used since the nineteenth century and their discovery by Hutchinson, are now currently performed in pediatrics hospitals but they require trained personnel. Spirometry can be a difficult technic, especially for children. The accuracy and repeatability depend on many factors: equipment, patient effort, supervision and encouragement of a technician. A longitudinal follow up of measures can be good especially in pediatric populations, where children have generally more difficulties recognising their symptoms.
Cystic fibrosis is a severe genetic chronic disease, that affects 1/4500 birth in France.
Read more
It's a multi system disease that affects the respiratory system, with a decline in lung function over the time and consecutive to pulmonary exacerbations, the digestive system (malabsorption of fat and vitamins) and the endocrine system (diabetes).
Pulmonary function is an important clinical indicator of the health of individuals with cystic fibrosis.
Close monitoring of patient health with daily recording of physical measurements and symptoms didn't have a negative impact, home spirometry function test could help detect earlier a decline of the lung function and pulmonary exacerbations.
Frequent exacerbations are associated with morbidity, mortality, accelerated decline in lung function and a decreased quality of life. They are also a major driver of health costs.Their early detection is a goal.
Children with cystic fibrosis have more difficulties recognizing symptoms of exacerbations.
Few studies in pediatric showed a good observance in realizing home spirometry, especially in young patients and those living far from the hospital and with a good satisfaction.
Daily monitoring of lung function is probably too tedious for children who already have lots of medication.
Medical adhesion of adolescent's patients is often suboptimal, compared with younger patients. But it's during this period that the decline of the respiratory function is the most important, with its principal cause: pulmonary exacerbations. Frequent home pulmonary function test is possible and can improve medication adherence without adding too much time, but there was no change in the decline of the FEV1 and the number of pulmonary exacerbations.
The association of home monitoring of lung function and a symptom questionary (cough, sputum and dyspnea) can predict exacerbation with a good specificity and sensibility.
The Mir Spirobank Smart is a bluetooth connected device, permitting patients to realize spirometry at home with a smartphone.
The accuracy of the Spirobank Smart compared with a spirometry in a hospital showed a good correlation (asthma and COPD population), if it's used by trained personnel.
The aim of this study is to determine the feasibility of a home respiratory monitoring in a pediatric cohort of patients with cystic fibrosis and the satisfaction of the kids, the parents and the team of the CRCM.
- Conditions
- Cystic Fibrosis in Children
- Being tested
- Spirobank Smart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirobank SmartDevice
Patients using the Spirobank Smart
| Study group | Role | What they receive |
|---|---|---|
| Patients using the Spirobank Smart | Other | Use of a portable spirometry Receives: Device: Spirobank Smart |
What is being measured
The primary outcome is the main question the study is designed to answer.
The observance of the realization of a follow up of pulmonary function in a cohort of cystic fibrosis's pediatric patients
Observance = the percentage (%) of measures realised during the 3 months, (number of measures done/ number of measures expected to be done according to the protocol)
Measured: 3 months
Secondary outcomes (1)
The workload of managing the alerts
The number of alerts received by each doctor and the number and therapeutic's changes following these alerts
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Apr 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
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 Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The spirometers have been purchased with charitable donations, that's why we have 35 of them.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie Mrs TATOPOULOS, Doctor, Principal investigator, CHRU Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837911
- Sponsor's protocol ID
- CHRU de Nancy
- Acronym
- SPIROMUCO
- Status last verified
- Mar 2021
- First submitted
- 30 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kruizinga MD, Essers E, Stuurman FE, Zhuparris A, van Eik N, Janssens HM, Groothuis I, Sprij AJ, Nuijsink M, Cohen AF, Driessen GJA. Technical validity and usability of a novel smartphone-connected spirometry device for pediatric patients with asthma and cystic fibrosis. Pediatr Pulmonol. 2020 Sep;55(9):2463-2470. doi: 10.1002/ppul.24932. Epub 2020 Jul 8.
PubMed 32592537Shakkottai A, Nasr SZ. The Use of Home Spirometry in Pediatric Cystic Fibrosis Patients: Results of a Feasibility Study. Glob Pediatr Health. 2017 Feb 2;4:2333794X17690315. doi: 10.1177/2333794X17690315. eCollection 2017.
PubMed 28229102Finkelstein SM, Wielinski CL, Kujawa SJ, Loewenson R, Warwick WJ. The impact of home monitoring and daily diary recording on patient status in cystic fibrosis. Pediatr Pulmonol. 1992 Jan;12(1):3-10. doi: 10.1002/ppul.1950120104.
PubMed 1579374Sarfaraz S, Sund Z, Jarad N. Real-time, once-daily monitoring of symptoms and FEV in cystic fibrosis patients--a feasibility study using a novel device. Clin Respir J. 2010 Apr;4(2):74-82. doi: 10.1111/j.1752-699X.2009.00147.x.
PubMed 20565480Shakkottai A, Kaciroti N, Kasmikha L, Nasr SZ. Impact of home spirometry on medication adherence among adolescents with cystic fibrosis. Pediatr Pulmonol. 2018 Apr;53(4):431-436. doi: 10.1002/ppul.23950. Epub 2018 Feb 19.
PubMed 29457700van Horck M, Winkens B, Wesseling G, van Vliet D, van de Kant K, Vaassen S, de Winter-de Groot K, de Vreede I, Jobsis Q, Dompeling E. Early detection of pulmonary exacerbations in children with Cystic Fibrosis by electronic home monitoring of symptoms and lung function. Sci Rep. 2017 Sep 27;7(1):12350. doi: 10.1038/s41598-017-10945-3.
PubMed 28955051Degryse J, Buffels J, Van Dijck Y, Decramer M, Nemery B. Accuracy of office spirometry performed by trained primary-care physicians using the MIR Spirobank hand-held spirometer. Respiration. 2012;83(6):543-52. doi: 10.1159/000334907. Epub 2012 Jan 21.
PubMed 22269344
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Portable Spirometer in Pediatric Patients With Cystic Fibrosis at the Nancy CHRU: Feasibility Study
- ClinicalTrials.gov ID
- NCT04837911
- Acronym / sponsor ID
- SPIROMUCO / CHRU de Nancy
- Conditions
- Cystic Fibrosis in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 8 Apr 2021 (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.
Respiratory diseases (asthma, cystic fibrosis, COPD…) need for the diagnosis and the follow-up the use of pulmonary function tests. These technics which are used since the nineteenth century and their discovery by Hutchinson, are now currently performed in pediatrics hospitals but they require trained personnel. Spirometry can be a difficult technic, especially for children. The accuracy and repeatability depend on many factors: equipment, patient effort, supervision and encouragement of a technician. A longitudinal follow up of measures can be good especially in pediatric populations, where children have generally more difficulties recognising their symptoms.
Cystic fibrosis is a severe genetic chronic disease, that affects 1/4500 birth in France.
It's a multi system disease that affects the respiratory system, with a decline in lung function over the time and consecutive to pulmonary exacerbations, the digestive system (malabsorption of fat and vitamins) and the endocrine system (diabetes).
Pulmonary function is an important clinical indicator of the health of individuals with cystic fibrosis.
Close monitoring of patient health with daily recording of physical measurements and symptoms didn't have a negative impact, home spirometry function test could help detect earlier a decline of the lung function and pulmonary exacerbations.
Frequent exacerbations are associated with morbidity, mortality, accelerated decline in lung function and a decreased quality of life. They are also a major driver of health costs.Their early detection is a goal.
Children with cystic fibrosis have more difficulties recognizing symptoms of exacerbations.
Few studies in pediatric showed a good observance in realizing home spirometry, especially in young patients and those living far from the hospital and with a good satisfaction.
Daily monitoring of lung function is probably too tedious for children who already have lots of medication.
Medical adhesion of adolescent's patients is often suboptimal, compared with younger patients. But it's during this period that the decline of the respiratory function is the most important, with its principal cause: pulmonary exacerbations. Frequent home pulmonary function test is possible and can improve medication adherence without adding too much time, but there was no change in the decline of the FEV1 and the number of pulmonary exacerbations.
The association of home monitoring of lung function and a symptom questionary (cough, sputum and dyspnea) can predict exacerbation with a good specificity and sensibility.
The Mir Spirobank Smart is a bluetooth connected device, permitting patients to realize spirometry at home with a smartphone.
The accuracy of the Spirobank Smart compared with a spirometry in a hospital showed a good correlation (asthma and COPD population), if it's used by trained personnel.
The aim of this study is to determine the feasibility of a home respiratory monitoring in a pediatric cohort of patients with cystic fibrosis and the satisfaction of the kids, the parents and the team of the CRCM.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The spirometers have been purchased with charitable donations, that's why we have 35 of them.
| Arm | Type | Receives |
|---|---|---|
| Patients using the Spirobank Smart | Other | Device: Spirobank SmartUse of a portable spirometry |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients with a cystic fibrosis diagnosis confirmed by a sweat chloride measurement ≥ 60 mmol/L
- Age between 10 and 20 years at enrolment
- Able to perform spirometry
- Having a smartphone
- Written consent adapted to the age
Key exclusion criteria (6 listed)
- Antibiotic therapy for a pulmonary exacerbation in the 2 weeks before enrollment
- Lung transplantation (past or future)
- Colonization with Bulkholderia cepacia in the last 2 years
- Absence of contentment
- Inability to access technology required to transmit home spirometry data
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 |
|---|---|---|
| Spirobank SmartPatients using the Spirobank Smart | Device | Patients using the Spirobank Smart |
Primary outcome
The observance of the realization of a follow up of pulmonary function in a cohort of cystic fibrosis's pediatric patients
Time frame: 3 months
Observance = the percentage (%) of measures realised during the 3 months, (number of measures done/ number of measures expected to be done according to the protocol)
1 secondary outcome
The workload of managing the alerts
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 32592537Kruizinga MD, Essers E, Stuurman FE, Zhuparris A, van Eik N, Janssens HM, Groothuis I, Sprij AJ, Nuijsink M, Cohen AF, Driessen GJA. Technical validity and usability of a novel smartphone-connected spirometry device for pediatric patients with asthma and cystic fibrosis. Pediatr Pulmonol. 2020 Sep;55(9):2463-2470. doi: 10.1002/ppul.24932. Epub 2020 Jul 8.
- Background: PubMed 28229102Shakkottai A, Nasr SZ. The Use of Home Spirometry in Pediatric Cystic Fibrosis Patients: Results of a Feasibility Study. Glob Pediatr Health. 2017 Feb 2;4:2333794X17690315. doi: 10.1177/2333794X17690315. eCollection 2017.
- Background: PubMed 1579374Finkelstein SM, Wielinski CL, Kujawa SJ, Loewenson R, Warwick WJ. The impact of home monitoring and daily diary recording on patient status in cystic fibrosis. Pediatr Pulmonol. 1992 Jan;12(1):3-10. doi: 10.1002/ppul.1950120104.
- Background: PubMed 20565480Sarfaraz S, Sund Z, Jarad N. Real-time, once-daily monitoring of symptoms and FEV in cystic fibrosis patients--a feasibility study using a novel device. Clin Respir J. 2010 Apr;4(2):74-82. doi: 10.1111/j.1752-699X.2009.00147.x.
- Background: PubMed 29457700Shakkottai A, Kaciroti N, Kasmikha L, Nasr SZ. Impact of home spirometry on medication adherence among adolescents with cystic fibrosis. Pediatr Pulmonol. 2018 Apr;53(4):431-436. doi: 10.1002/ppul.23950. Epub 2018 Feb 19.
- Background: PubMed 28955051van Horck M, Winkens B, Wesseling G, van Vliet D, van de Kant K, Vaassen S, de Winter-de Groot K, de Vreede I, Jobsis Q, Dompeling E. Early detection of pulmonary exacerbations in children with Cystic Fibrosis by electronic home monitoring of symptoms and lung function. Sci Rep. 2017 Sep 27;7(1):12350. doi: 10.1038/s41598-017-10945-3.
- Background: PubMed 22269344Degryse J, Buffels J, Van Dijck Y, Decramer M, Nemery B. Accuracy of office spirometry performed by trained primary-care physicians using the MIR Spirobank hand-held spirometer. Respiration. 2012;83(6):543-52. doi: 10.1159/000334907. Epub 2012 Jan 21.
- 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.
Aurélie Mrs TATOPOULOS, Doctor principal investigator
CHRU Nancy, France
Questions about this trial
What is this clinical trial studying?
A study testing Spirobank Smart in people with Cystic Fibrosis in Children, run by Central Hospital, Nancy, 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 6 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: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Aurélie Mrs TATOPOULOS, Doctor (033383154556, au.tatopoulos@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The observance of the realization of a follow up of pulmonary function in a cohort of cystic fibrosis's pediatric patients (time frame: 3 months). 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 NCT04837911, 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 8 Apr 2021.