Positive Expiratory Pressure During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis

Universidad San Jorge

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Device: INHALATION WITH PEP DEVICE (Acapella Duet)

Study type: Interventional

Funder types: Other

Identifiers

NCT02303808

239|2012 (Other Grant/Funding Number)

FQ_INH_PEP_01

Details and patient eligibility

About

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).

Full description

All patients will perform two different arms of treatment in a crossover randomization. Each arm of treatment will be applied during 5 consecutive days. The wash-out period will be one week. Before starting the trial all patients will do an inhalation formation.

During the study period the patients' pharmacological treatment remains unchanged

Enrollment: 20 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

USUAL CARE

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: INHALATION WITH PEP DEVICE (Acapella Duet)