Overview

This trial has been completed.

Condition cystic fibrosis
Treatments autogenic drainage (ad), resistive inspiratory manoeuvre (rim), resistive inspiratory manoeuvre+autogenic drainage
Sponsor Universidad San Jorge
Collaborator Cystic Fibrosis Foundation Therapeutics
Start date November 2014
End date May 2016
Trial size 32 participants
Trial identifier NCT02261987, FR_FQ- 013

Summary

This trial aims to analyze whether the resistive inspiratory manoeuvre (RIM) performed previously to autogenic drainage (AD) technique improves the effectiveness in terms of mucus clearance during a typical bronchial drainage session in adults, stable CF patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Patients will perform the autogenic drainage technique following the Chevallier and Agostini recommendations.
autogenic drainage (ad)
It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.
(Active Comparator)
Patients will perform the repetitive inspiratory manoeuvers by breathing through a fixed resistance (Power Breathe device, model KH1) . Each session will comprise to cycles of 5 inspiratory breaths (60% of maximal inspiratory pressure). Patients will be stay in both lateral decubitus position (15 min per side).
resistive inspiratory manoeuvre (rim)
It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.
(Active Comparator)
First, patients will perform the resistive inspiratory manoeuvre during 10 minutes (5 min per side). Right after, patients will perform the autogenic drainage during 20 minutes.The instructions will be similar to described previously.
resistive inspiratory manoeuvre+autogenic drainage
It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.

Primary Outcomes

Measure
Wet sputum production
time frame: 24 hours

Secondary Outcomes

Measure
Wet sputum production
time frame: 30 minutes
Computerized respiratory sounds
time frame: 30 minutes
Lung function (simply spirometry)
time frame: 30 minutes
Patients´ perception
time frame: 30 minutes

Eligibility Criteria

Male or female participants at least 16 years old.

Inclusion Criteria: - Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium>70 mmol/l or sweat chloride of>60 mmol/l) - Clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk); - Chronic sputum production, at least ≥ 15 ml /24h - Familiar and trained in the use of autogenic drainage technique (at least 6 months) and resistive inspiratory manoeuvre (at least three previous sessions) - To be able to provide written, informed consent Exclusion Criteria: - Lung function: Forced expiratory volume in 1 second < 30 % pred . ; Forced vital capacity < 40 % pred. - Active haemoptysis during the previous month - Supplemental oxygen or non-invasive ventilation (NIV)

Additional Information

Official title Role of Resistive Inspiratory Manoeuvres During Bronchial Drainage Session in Cystic Fibrosis: a Randomized Crossover Trial
Principal investigator Beatriz Herrero, Msc
Description It is a multicenter study. 4 different Spain Cystic Fibrosis Foundations are included in the study (Madrid, Valencia, Murcia and Aragón). All patients will perform three different arms of treatment in a crossover randomization. Each arm of treatment will be apply only in one session. The wash-out period will be one week. Before starting the trial, all patients will perform a control session without any intervention, only the outcome measures will be assess. During the study period the patients' pharmacological treatment remained unchanged
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Universidad San Jorge.