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

Not Applicable

• Conditions: cystic fibrosis; C06.689.202

• Registration Number: RBR-9rzr3r
• Lead Sponsor: Renata Maba Gonçalves

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.