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Effects of hypertonic saline and Dornase alfa in children with cystic fibrosis

Immediate effects of hypertonic saline and Dornase alfa on respiratory mechanics in children with cystic fibrosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9rzr3r
Enrollment
Unknown
Registered
2019-10-16
Start date
2014-02-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cystic fibrosis

Interventions

Therapeutic procedures include inhalation of two inhaled therapies, namely DNase and HSS, and the high frequency oral oscillation physiotherapy (OHFO) procedure. The study subjects will be divided int
Drug
Device
E02.779

Sponsors

Renata Maba Gonçalves
Lead Sponsor
Hospital Infantil Joana de Gusmão
Collaborator

Eligibility

Age
6 Years to 14 Years

Inclusion criteria

Inclusion criteria: This study included children and adolescents with CF between 6 to 14 years of age, under regular follow-up at the CF outpatient clinic in the Joana de Gusmão Children's Hospital (HIJG) in Florianópolis/SC-Brazil. The diagnosis was confirmed by two altered sweat tests (chlorine greater than 60mEqs/l) and confirmed genetic alterations. All participants were clinically stable at the time of data collection, according to the application of specific clinical scores. To assure clinical stability and inclusion of the participants, the Cystic Fibrosis Clinical Score (CFCS) [18] and the Cystic Fibrosis Foundation Score (CFFS) [19] for pulmonary exacerbation were applied.

Exclusion criteria

Exclusion criteria: Individuals who exhibited infection or upper airway alterations (coryza, sneezing, obstruction of nose, rhinitis and epistaxis) and who were unable to perform any of the study procedures were excluded from the study.

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of inhalation therapy associated with respiratory physiotherapy on respiratory mechanics in children with cystic fibrosis, using the two main inhalation therapies already used by patients and evaluating with the Pulse Oscillometry System.;To evaluate the effect of inhalation therapy associated with respiratory physiotherapy on pulmonary function in children with cystic fibrosis, using the two main inhalation therapies already used by patients and evaluating with spirometry.

Secondary

MeasureTime frame
To verify the relationship of the IOS variables with age, BMI and cystic fibrosis severity classification data, the referred parameters will be collected and the relationship will be made by statistical analysis.

Countries

Brazil

Contacts

Public ContactRenata Wamosy

Universidade do Estado de Santa Catarina

renata.maba@gmail.com36641007

Outcome results

None listed

Source: REBEC (via WHO ICTRP)