NCT02303808

Brief Summary

This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

November 25, 2014

Last Update Submit

December 1, 2015

Conditions

Cystic Fibrosis

Keywords

Hyperosmolar agentsHypertonic salineAirway clearance techniquesPositive Expiratory PressureAutogenic drainage

Outcome Measures

Primary Outcomes (1)

  • Wet sputum production

    Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage)

    45 minutes

Secondary Outcomes (6)

  • Wet sputum production

    2 hours

  • Wet sputum production

    22 hours

  • Lung function (simply spirometry)

    5 days

  • Safety and tolerability of session (Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate)

    45 minutes

  • Patient's perception (Likert test)

    5 days

  • +1 more secondary outcomes

Study Arms (2)

USUAL CARE

NO INTERVENTION

Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes.

INHALATION WITH PEP DEVICE

ACTIVE COMPARATOR

Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) combined with a PEP device (Acapella Duet) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes.

Device: INHALATION WITH PEP DEVICE (Acapella Duet)

Interventions

INHALATION WITH PEP DEVICE (Acapella Duet)DEVICE

Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized.

INHALATION WITH PEP DEVICE

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pass the inhalation test
  • Chronic sputum production, at least ≥ 10 ml /24h
  • Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium\>70 mmol/l or sweat chloride of\>60 mmol/l)
  • Clinically stable at the time of recruitment (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 weeks)
  • Trained in the use of autogenic drainage technique (at least 6 months)
  • Inhaling hypertonic saline since at least 6 months
  • To be able to provide written, informed consent and perform the protocol and the evaluations

You may not qualify if:

  • Active massive hemoptysis during the previous 2 months
  • Patient in transplantation or retransplantation list
  • Patient already participating in another study at the same time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociación Aragonesa de Fibrosis Quística

Zaragoza, Spain

Location

Related Publications (2)

  • Wark P, McDonald VM, Smith S. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD001506. doi: 10.1002/14651858.CD001506.pub5.

    PMID: 37319354DERIVED

  • San Miguel-Pagola M, Reychler G, Cebria I Iranzo MA, Gomez-Romero M, Diaz-Gutierrez F, Herrero-Cortina B. Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cystic fibrosis: a randomised crossover trial. Physiotherapy. 2020 Jun;107:243-251. doi: 10.1016/j.physio.2019.11.001. Epub 2019 Nov 11.

    PMID: 32026826DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marta San Miguel

    Universidad San Jorge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

December 1, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

ES(1)