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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva

NCT00274066

Pulmonary Disease, Chronic Obstructive

COMPLETED PHASE3

Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

NCT01449292

Pulmonary Emphysema

TERMINATED PHASE3

Open-Label Assessment of the Albuterol Spiromax® Dry Powder Inhaler (DPI)

NCT01857323

Asthma Chronic Obstructive Pulmonary Disease (COPD)

COMPLETED PHASE3

COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2

NCT04858451

COPD Bronchiectasis

TERMINATED PHASE2

Novel Therapies for Muco-Obstructive Lung Diseases: Testing the Transnasal Pulmonary Delivery Device in COPD/CB Subjects

NCT02341183

COPD Chronic Bronchitis

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

standard treatment

Intervention Type DEVICE

20 minutes, twice a day for 10 sessions

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.

Group Type EXPERIMENTAL

Free Aspire

Intervention Type DEVICE

20 minutes, twice a day for 10 sessions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

standard treatment

20 minutes, twice a day for 10 sessions

Intervention Type DEVICE

Free Aspire

20 minutes, twice a day for 10 sessions

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PEP bottle

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)