Randomized Trial of the FreeAspire Versus PEP-bottle After Acute Exacerbation in COPD Patients
Condition: COPD
Study type: Interventional

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.
    

Intervention name(s): standard treatment; Free Aspire
Intervention type(s): Device; Device
Intervention description(s): 20 minutes, twice a day for 10 sessions; 20 minutes, twice a day for 10 sessions
Other intervention name(s): PEP bottle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment