Randomized Trial of the FreeAspire Versus PEP-bottle After Acute Exacerbation in COPD Patients

A Preliminary Randomized Trial of the FreeAspire Versus PEP-bottle After Acute Exacerbation in COPD Patients With Mucus Hypersecretion and Decreased Cough Efficiency.

BACKGROUND: Studies have shown that COPD patients with bronchial hypersecretion have increased risk of acute exacerbations. FREE ASPIRE is an electro-medical device which removes bronchopulmonary secretions noninvasively, without using a suction catheter and without generating airway pressure.

AIM: To compare FREE ASPIRE activity with the traditional treatment using PEP-bottle in the clearance of bronchial secretions in COPD patients METHODS: Forty severe and very severe COPD patients with mucus and reduced cough will be evaluated. Group comparison will be made between Intervention group using VAKÜM system (Free Aspire®), and Control group using traditional treatment with PEP-bottle over 10 daily sessions (20 minutes twice a day). Primary outcomes are changes in arterial blood gases exchanges, in perceived dyspnea and in symptom of bronchial encumbrance.

EXPECTED RESULTS: A higher significant reduction of the perceived dyspnea and of perceived bronchial encumbrance is supposed in the Intervention group. Additional benefits among the secondary outcomes are also hypothesized in the same group.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Device: standard treatment; Device: Free Aspire

Detailed Description

Background. Chronic obstructive pulmonary disease (COPD) is a complex and heterogeneous disease, whose pathophysiological aspects remain still today unknown. Among the various phenotypes, chronic bronchitis presents mucus hypersecretion as clinical distinctive character, having also a pathogenic role. Studies have shown that COPD patients with bronchial hypersecretion have increased risk of acute exacerbations. This risk has a negative impact on disease progression, quality of life of patients and direct and indirect costs. It is necessary to identify more efficient instruments and techniques that allow to obtain airway clearance, usable in most clinical settings, including rehabilitation centers, and suitable for the largest number of patients. FREE ASPIRE is an electro-medical device which removes bronchopulmonary secretions noninvasively, without using a suction catheter and without generating airway pressure, positive or negative. FREE ASPIRE uses a VAKÜM technology , by accelerating expiratory flow of airways, and it can also be used in patients with reduced cough efficiency.

Aim of the study. To compare FREE ASPIRE activity with the traditional treatment using PEP-bottle in the clearance of bronchial secretions in COPD patients with mucus hypersecretion and decreased cough efficiency, and to test the hypothesis that the newly developed VAKÜM technology may provide additional clinical benefits over conventional treatment in terms of clinical and functional outcomes.

Materials and methods. This is a single center, randomized and preliminary prospective study. The study has been approved by the Internal Review Board of the Malcantonese Hospital, 6980 Castelrotto, Switzerland and the procedures will be performed in the Division of Internal and Respiratory Medicine. Following a preliminary run-in period, group comparison will be made between Intervention group using VAKÜM system (Free Aspire, MPR, Legnano, Italy), and Control group using traditional treatment with PEP-bottle over 10 daily sessions (20 minutes twice a day). All patients will receive regular treatment with inhaled bronchodilators and inhaled steroids according to current guidelines for their disease stage. Each patient will sign an informed consent form. Considering a probability of 15% drop-out rate of randomized patients, we consider to enroll at least 24 patients per group.

Spirometric lung volumes, respiratory muscle strength (MIP and MEP), arterial blood gases, perceived dyspnea (by BDI-TDI scale), peak expiratory air flows (PEF and PCEF), perceived bronchial encumbrance (by VAS scale) and quality of life (Clinical COPD Questionnaire, CCQ, CAT) will be recorded in both groups pre-to-post PR.

Continuous data will be reported as mean ± standard deviation (SD), unless otherwise specified. The distribution of variables will be assessed by means of Kolmogorov-Smirnov Goodness-of-Fit test. Comparisons between quantitative and qualitative variables will be determined by paired and unpaired t test, and χ2 test, when appropriate. Relationships between variables will be assessed by the Pearson's correlation coefficient (r) and the Spearman's correlation coefficient (rs), when appropriate. Data analyses and graphical presentations will be performed using GraphPad Prism 5 (GraphPad Software, San Diego, California, USA) and SPSS version 20 (IBM, Armonk, New York, USA). A p-value < 0.05 will be considered as statistically significant.

Study start date: January 2016 Estimated study completion date: June 2017 Expected results. A higher significant reduction of the perceived dyspnea and of perceived bronchial encumbrance is supposed in the Intervention group. Additional benefits among the secondary outcomes are also hypothesized in the same group.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • VA
    • Tradate, VA, Italy, 21049
      • Maugeri Foundation
• Switzerland
  • TI
    • Castelrotto, TI, Switzerland, 6980
      • Division of Internal and Respiratory Medicine, Ospedale Malcantonese, Fondazione Giuseppe Rossi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

COPD patients with:

• severe and very severe airflow obstruction (FEV1<50%)
• mucus hypersecretion (sputum production >30 ml/die)
• reduced cough efficiency (Peak Cough Expiratory Flow > 160 and < 300 l/min)

Exclusion Criteria:

• Any medical or psychological condition that in opinion of the investigator influences the ability to follow the programme

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard treatment; Control group will be made of 20 COPD patients with severe and very severe airflow obstruction, mucus hypersecretion and reduced cough efficiency referred to standard pulmonary rehabilitation after acute exacerbation. Control group will b treated with PEP-bottle over 10 daily sessions (20 minutes twice a day). Patients are asked to breath against a positive expiratory pressure determined by a column of water in a bottle (PEP Bolltle). PEP is one of the validated treatment used in the clearance of bronchial secretions in COPD patients. All patients will receive regular treatment with inhaled bronchodilators and inhaled steroids according to current guidelines for their disease stage. Each patient will sign an informed consent form.	Device: standard treatment; 20 minutes, twice a day for 10 sessions; Other Names: PEP bottle
Experimental: Free Aspire; Experimental group will be made of 20 COPD patients with severe and very severe airflow obstruction , mucus hypersecretion , and reduced cough efficiency referred to standard pulmonary rehabilitation after acute exacerbation. Patients are asked to use FREE ASPIRE Free Aspire is an electro-medical device which removes bronchopulmonary secretions noninvasively, without using a suction catheter and without generating airway pressure, positive or negative. All patients will receive regular treatment with inhaled bronchodilators and inhaled steroids according to current guidelines for their disease stage. Each patient will sign an informed consent form.	Device: Free Aspire; 20 minutes, twice a day for 10 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perceived symptom of bronchial encumbrance	VAS Scale	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in arterial blood gases exchanges	BGA	10 days
perceived dyspnea	BDI-TDI	10 days
changes in peak expiratory air flows	PFT	10 days
lung volumes	PFT	10 days
respiratory muscle strength	MIP-MEP	10 days

Collaborators and Investigators

• Sponsor: Maugeri Foundation
• Investigators: Study Director: Antonio Spanevello, MD, Maugeri Foundation

Publications and helpful links

General Publications

• Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
• Prescott E, Lange P, Vestbo J. Chronic mucus hypersecretion in COPD and death from pulmonary infection. Eur Respir J. 1995 Aug;8(8):1333-8. doi: 10.1183/09031936.95.08081333.
• Bellone A, Lascioli R, Raschi S, Guzzi L, Adone R. Chest physical therapy in patients with acute exacerbation of chronic bronchitis: effectiveness of three methods. Arch Phys Med Rehabil. 2000 May;81(5):558-60. doi: 10.1016/s0003-9993(00)90034-0.
• Osadnik CR, McDonald CF, Jones AP, Holland AE. Airway clearance techniques for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD008328. doi: 10.1002/14651858.CD008328.pub2.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: maugerifoundation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: publication