High Volumes of Hypertonic Saline and Chest Physiotherapy in CF Patients

Cystic Fibrosis Clinical Trial

Official title:

Establishment and Implementation of Nebulised High Volumes of Hypertonic Saline in Cystic Fibrosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943890
• Other study ID #: 2009/2125
• Status: Completed
• Phase: N/A
• First received: May 16, 2012
• Last updated: September 16, 2013
• Start date: February 2010
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Background Nebulised hypertonic saline (HS) is an established basic airway clearance treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical implementation and administration of different HS volumes, including physiotherapy and aspects of breathing pattern.

The aim of the study was to implement standardised and age-adjusted nebulised volumes of hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage techniques.

Description:

Aims: To establish a safe, efficient routine for implementation of HS in daily treatment and to investigate the efficiency and tolerance of high volumes of HS integrated with chest physiotherapy.

HS was given twice daily with volumes of 4,5 ml in children aged 0-5 years, 6 ml at age 6-16 years and 9 ml at age > 16 years. The protocol included guidance of standardized breathing pattern, upright and sideways positioning and voluntary cough.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Cystic fibrosis

Exclusion Criteria:

• Non-adherence

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• Hypertonic saline
1 mmol/ml hypertonic saline given from (small children) 1,5 ml in 3 positions twice daily increasing to (children) 2 ml in 3 positions twice daily and up to (adults) 3 ml in 3 positions twice daily

Procedure:
• Physiotherapy

Locations

Country	Name	City	State
Norway	Dept. of Thoracic Medicine, Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second		24 months	Yes
Secondary	Implementation of nebulised high volumes of hypertonic saline in cystic fibrosis patients	Establishment of a standardized routine of nebulised high volumes of hypertonic saline including chest physiotherapy in cystic fibrosis patients	24 months	No