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

NCT02640430 | Completed DMC

• 1 other identifier: maugerifoundation
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• perceived symptom of bronchial encumbrance

  VAS Scale

  10 days

Secondary Outcomes (5)

• changes in arterial blood gases exchanges

  10 days

• perceived dyspnea

  10 days

• changes in peak expiratory air flows

  10 days

• lung volumes

  10 days

• respiratory muscle strength

  10 days

Study Arms (2)

standard treatment

ACTIVE COMPARATOR

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

Free Aspire

EXPERIMENTAL

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

Interventions

standard treatment DEVICE

20 minutes, twice a day for 10 sessions

Also known as: PEP bottle

standard treatment

Free Aspire DEVICE

20 minutes, twice a day for 10 sessions

Free Aspire

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Maugeri Foundation: lead

Study Sites (2)

Maugeri Foundation

Tradate, VA, 21049, Italy

Location

Division of Internal and Respiratory Medicine, Ospedale Malcantonese, Fondazione Giuseppe Rossi

Castelrotto, Canton Ticino, 6980, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 10807091 BACKGROUND

• Osadnik CR, McDonald CF, Jones AP, Holland AE. Airway clearance techniques for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD008328. doi: 10.1002/14651858.CD008328.pub2.

  PMID: 22419331 BACKGROUND

• 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.

  PMID: 22878278 BACKGROUND

• 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.

  PMID: 7489800 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Spanevello, MD

  Maugeri Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 29, 2015
• Study Start: October 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: December 31, 2018
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (1); CH (1)