Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Role of Resistive Inspiratory Manoeuvres During Bronchial Drainage Session in Cystic Fibrosis: a Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261987
• Other study ID #: FR_FQ- 013
• Status: Completed
• Phase: N/A
• First received: October 7, 2014
• Last updated: November 11, 2016
• Start date: November 2014
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Respiratory Aspiration

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Cystic Fibrosis Association	Madrid
Spain	Cystic Fibrosis Association	Murcia
Spain	Cystic Fibrosis Association	Valencia
Spain	Universidad San Jorge	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Universidad San Jorge	Cystic Fibrosis Foundation Therapeutics

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Chatham K, Ionescu AA, Nixon LS, Shale DJ. A short-term comparison of two methods of sputum expectoration in cystic fibrosis. Eur Respir J. 2004 Mar;23(3):435-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pulse-oximetry, heart rate and dyspnea	Safety and tolerability of session	30 minutes	No
Primary	Wet sputum production	24h wet sputum production (g) after bronchial drainage session	24 hours	No
Secondary	Wet sputum production	Wet sputum production (g) during bronchial drainage session	30 minutes	No
Secondary	Computerized respiratory sounds	Adventitous respiratory sounds: crackles and wheezes	30 minutes	No
Secondary	Lung function (simply spirometry)	Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75	30 minutes	No
Secondary	Patients´ perception	Visual analogical scale	30 minutes	No