NCT01943890

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2012

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

1.8 years

First QC Date

May 16, 2012

Last Update Submit

September 16, 2013

Conditions

Cystic Fibrosis

Keywords

Hypertonic salineLung physiotherapy

Outcome Measures

Primary Outcomes (1)

  • Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second

    24 months

Secondary Outcomes (1)

  • Implementation of nebulised high volumes of hypertonic saline in cystic fibrosis patients

    24 months

Study Arms (1)

Physiotherapy and hypertonic saline

EXPERIMENTAL

Chest physiotherapy integrated with inhalation of hypertonic saline

Device: Hypertonic salineProcedure: Physiotherapy

Interventions

Hypertonic salineDEVICE

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

Physiotherapy and hypertonic saline
PhysiotherapyPROCEDURE
Physiotherapy and hypertonic saline

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cystic fibrosis

You may not qualify if:

  • Non-adherence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Thoracic Medicine, Haukeland University Hospital

Bergen, N-5021, Norway

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Stian Hammer

    Dept. of Physiotherapy, Haukeland University Hospital, Bergen, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2012

First Posted

September 17, 2013

Study Start

February 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

NO(1)