CClinicalTrials.gg
Status unknownNCT04837911SPIROMUCOUpdated Apr 8, 2021

Use of a Portable Spirometer in Pediatric Patients With Cystic Fibrosis at the Nancy CHRU: Feasibility Study

An interventional study of Spirobank Smart in Cystic Fibrosis in Children, sponsored by Central Hospital, Nancy, France. Status unknown. Open to participants aged 10 Years to 20 Years. Per ClinicalTrials.gov, last updated 2021-04-08.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
10 Years to 20 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cystic Fibrosis in Children
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's planned enrollment of 35 is close to the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Other
    Patients using the Spirobank Smart

    Use of a portable spirometry

    Device: Spirobank Smart

Interventions

  • DeviceSpirobank Smart

    Patients using the Spirobank Smart

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: 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

    Time frame: 3 months

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Study locations

No study locations are listed for this record.

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References and documents

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 32592537 ↗
  • Shakkottai 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 28229102 ↗
  • Finkelstein 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 1579374 ↗
  • Sarfaraz 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 20565480 ↗
  • Shakkottai 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 29457700 ↗
  • van 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. Erratum In: Sci Rep. 2018 Dec 13;8(1):17946. doi: 10.1038/s41598-018-36407-y. PubMed 28955051 ↗
  • Degryse 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04837911
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Apr 8, 2021
Start date
Apr 1, 2021 (estimated)
Primary completion
Sep 30, 2021 (estimated)
Completion
Apr 1, 2022 (estimated)
Last update
Apr 8, 2021

Study contacts

Aurélie Mrs TATOPOULOS, Doctor
Contact
au.tatopoulos@chru-nancy.fr
033383154556
Aurélie Mrs TATOPOULOS, Doctor
principal investigator · CHRU Nancy, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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