Clinical trial NCT02640430: Randomized Trial of the FreeAspire Versus PEP-bottle After Acute Exacerbation in COPD Patients
Official title: A Preliminary Randomized Trial of the FreeAspire Versus PEP-bottle After Acute Exacerbation in COPD Patients With Mucus Hypersecretion and Decreased Cough Efficiency.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: Maugeri Foundation
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: perceived symptom of bronchial encumbrance
timeFrame: 10 days
Secondary outcomes:
measure: changes in arterial blood gases exchanges
timeFrame: 10 days
measure: perceived dyspnea
timeFrame: 10 days
measure: changes in peak expiratory air flows
timeFrame: 10 days
measure: lung volumes
timeFrame: 10 days
measure: respiratory muscle strength
timeFrame: 10 days
Other outcomes:
Locations:
city: Tradate
country: Italy
facility: Maugeri Foundation
state: VA
city: Castelrotto
country: Switzerland
facility: Division of Internal and Respiratory Medicine, Ospedale Malcantonese, Fondazione Giuseppe Rossi
state: TI
Study officials:
affiliation: Maugeri Foundation
name: Antonio Spanevello, MD
role: STUDY_DIRECTOR
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