Acute Asthma Exacerbation Clinical Trial: Frolov Breathing Device
"Results of Application of the Frolov Breathing Device TDI-01 on Patients with Bronchial Asthma"
BV Baluda, Professor, MD, Demidov YI, Serov VV (all from the
Department of Interior Diseases, Moscow Stomatological Institute,
Moscow, Russia), Razin AS (Biochemical Laboratory of Scientific
Problems, Moscow, Russia)
Published in the book "Theory and Practice of
Healthy Breathing", edited by Professor Tsirelnikov NI, Scientific
Centre of Clinical and Experimental Medicine of the Siberian Branch of
the Russian Academy of Medical Sciences, Dinamika Co Ltd., Novosibirsk,
The objective of the present research was investigation of the
influence of the individual device TDI-01 (Frolov breathing device) on
the respiratory system during complex therapy of patients with
bronchial asthma of moderate severity (3-rd degree) during a stage of
unstable remission (a diminishing acute asthma exacerbation). For
achievement of the specified objective, the following tasks have been
1. Comparison of efficiency of the standard therapy and the complex
approach that includes the use of the breathing device TDI-01 in
combination with standard therapy in patients with bronchial asthma.
2. To estimate the influence of hypercapnic training with the
breathing device TDI-01 on clinical manifestations of bronchial asthma,
the state of ventilation of lungs, gas exchange and processes of
peroxidation of lipids.
3. To test the recommended procedure with the use of the Frolov
breathing device in complex therapy of a bronchial asthma of moderate
severity (3-rd degree) during a stage of unstable remission (a
diminishing acute asthma exacerbation).
To address these issues 20 patients with bronchial asthma were
observed. The experimental group included 12 patients (6 men and 6
women) with the average age 43,9 years, 11 of whom had bronchial asthma
of the moderate-severe degree (3) and 1 patient had endogeneous asthma
(aspirin-induced) with symptoms of atopic asthma in response to skin
pollen antigens (3-rd degree).
The control group had 8 patients, who, according to the main
parameters of selection (the diagnosis of disease, its form, stage, age
and gender) did not differ from the experimental group. Only the
experimental group practiced breathing normalization by hypercapnic
training with the use of the breathing device TDI-01.
The investigation of patients was carried out in the hospital
(Spaso-Perovsky Hospital of Peace and Mercy, Moscow, Russia) 10-12 days
after their arrival in the Pulmonary Department when the elimination of
acute asthma exacerbation had been controlled and after the elimination
of the emergency room treatment (a short course of glucocorticoids,
parental introduction of sympathomimetic drugs and xantine
derivatives). Thus, the patients of the experimental group, at the time
of our initial investigation and at the beginning of the use of the
breathing device TDI-01, were in a stage of unstable remission.
Consequently, all observable patients continued inhalation of
glucocorticoids (mainly Ingacort with a daily dose of 1,500 mkg), short
acting bronchodilators (Berotec, Ventolin, with a daily doze of 600 -
800 mkg), and long-acting theophyllines (Teopek 0,3 g 2 times per day).
For measuring of the pulmonary parameters, diagnostic devices
"Transferscreen-2" and "Bodyscreen-2" (both from Erich Jäger GmbH;
Höchberg, Germany) were used. The latter measured: spirometry,
pneumotachometry, body plethysmography, and transfer factor of carbon
monoxide (diffusion capacity of the lungs) in a stable regime. The
analysis of a system "lipid peroxidation - antioxidant protection"
involved calculation of a content of by-products of free radical
oxidation of lipids (malondialdehyde) in erythrocytes (MDAer) and
plasma (MDApl) (the Goncharenko method, 1985) and calculation of the
ratio of AOA (antioxidant activity) to the sum of MDAer and MDApl for
an assessment of FAPO (functional antioxidant protection of the
organism). Statistical analysis of results was conducted using the
nonparametric criteria of Wilkinson and variational statistics with the
use of Student's T test.
To encourage active participation in the medical treatment,
explanatory conversations with each patient were arranged.
According to the instructions, patients in the experimental group,
within 10-12 days of their stay in a hospital and under our
supervision, achieved 20 seconds duration of their respiratory cycle
with the use of 20 ml of liquid (a physiological solution) for creation
of additional resistance during inhalations and exhalations. The
average duration of training sessions throughout the whole study was 20
minutes 2 times day.
The assessment of the initial state of their respiratory systems in
the experimental and control group was carried out during a phase of
the decreasing acute asthma exacerbation (on 10-12 days of patients'
arrival in the hospital). From this time the experimental group, in
addition to the pathogenic and symptomatic medication therapy, engaged
in a recovery therapy program using the TDI-01 (Frolov breathing
device) for the next 10-12 days of their stay in the hospital. The
patients of the control group had the standard therapy including
inhaled sympathomimetic drugs, glucocorticoids and application of
On days 24 and 25 of inpatients hospitalization, they all were
discharged, while the patients of the experimental group continuing to
use the TDI-01 device. One month after their discharge from the
hospital, we conducted a repeated assessment of the respiratory system
in patients of both analyzed groups.
During the initial functional investigation of the respiratory
system, patients of the experimental and control groups had moderate
respiratory abnormalities of an obstructive type with structural shifts
in the TLC (total lung capacity) of the lungs, which was accompanied by
increased RV (residual volume). This lead to significant
ventilation-perfusion mismatch expressed in significant decrease of
DLCO (diffusion lung capacity for carbon monoxide) [also known as TLCO
(transfer factor of the lung for CO)] in the stable state. In the main
and control groups the initial investigation did not reveal any
statistically meaningful differences in their volumes, rates, and
parameters of gas exchange (Table 1).
Dynamics of Lung Function Parameters in Patients with
Bronchial Asthma Depending on the Program of Treatment
||Experimental Group (12 people)
||Control Group (8 people)
Table abbreviations: EVC (expiratory vital capacity); RV (residual
volume); TLC (total lung capacity); FEV1 (forced expiratory volume in 1
second); FEV1 (forced expiratory volume in 1 second); FEF (forced
expiratory flow 25-50-75%); DLCO (diffusion lung capacity for carbon
monoxide); * - the difference with the control group is statistically
significant; s - significant change; ns - non-significant change.
After 1 month we found the positive dynamics in the computer
analysis of the "flow-volume" loops for the main group, elimination of
the pulmonary hyperinflation (RV reached normal and arbitrarily normal
values - 117,2~+mn~7,1 %) (Appendix 2). The specified favorable changes in
ventilation of the lungs caused statistically meaningful positive
dynamics in gas exchange in the lungs. This was expressed in the
increase of DLCO demonstrating improved ventilation-perfusion ratio in
different parts of the lungs.
In contrast, in the control group (maintained on the standard
therapy only) the parameters of ventilation and gas exchange did not
change significantly and remained significantly different from the
Improvements in the pulmonary parameters in the main group were
accompanied by positive clinical data which were characterized by:
decrease in the frequency of dyspneic episodes during the day,
improvements in the quality of sleep (decrease in the frequency of
breathlessness during the night), improved tolerance to physical
exercise, increase in the subjective threshold of shortness of breath
(2 patients independently carried out numerous successful attempts to
eliminate symptoms of heavy breathing with the use of the TDI-01). The
above-stated clinical changes and the positive dynamics in pulmonary
function parameters allowed us to lower their doses of inhaled
glucocorticoids from about 1,500 mkg down to 1,000 mkg due to requests
of patients during follow-up visits and individually reduce the
frequency of their use of sympathomimetic drugs.
In the control group, the clinical data and pulmonary parameters did
not improve significantly. Therefore, it was recommended to these
patients to maintain during the next 2 months the basic pathogenetic
and symptomatic therapy in the initial dose.
During the initial investigation of the system "lipid peroxidation -
antioxidant protection", we discovered the state of oxidative stress
manifested in the essential rise of a level of by-products of lipid
peroxidation, especially MDAer (malondialdehyde in erythrocytes). This
demonstrated significant destructive changes in the biological
membranes of blood plasma cells and was within the normal range values
in both groups. However, in conditions of such significant growth in
free-radical oxidation, the functional antioxidant defense of the
organism sharply decreased.
Dynamics of Parameters of the System "Lipid
Peroxidation - Antioxidant Protection" in Patients with Bronchial
Asthma Depending on the Program of Treatment
||Experimental Group (12 people)
||Control Group (8 people)
Table abbreviations: MDAer (malondialdehyde in erythrocytes); MDApl
(malondialdehyde in plasma); AOA (antioxidant activity); FAPO
(functional antioxidant protection of the organism); * - the difference
with the control group is statistically significant; s - significant
change; ns - non-significant change.
On a background of the conducted treatment, the main group
experienced statistically significant reduction in by-products of lipid
peroxidation. This led to to growth in the parameter of functional
antioxidant protection of the organism (FAPO). We noticed positive
changes in the system "lipid peroxidation - antioxidant protection".
but these changes did not have statistical significance. It is
necessary to note that, after 1 month after their hospital discharge,
the patients of the main and control groups had essential stress in the
analyzed homeostatic system since MDAer, as well as MDApl did not
achieve normal values, although antioxidant protection of the organism
in the main group was reliably higher than the initial values.
Thus, the obtained results allow us to make a preliminary conclusion
about positive effects of the respiratory device TDI-01 on the
respiratory system of patients with moderate-severe bronchial asthma
during a stage of unstable remission (a diminishing acute asthma
exacerbation). Its clinical recovery and rehabilitations effects
1. Improvement in bronchial conductivity and decrease of
hyperinflation of the lungs, which is probably connected with positive
pressure during exhalation leading the prevention of the expiratory
collapse of small respiratory airways and decrease in expressiveness of
signs of bronchotracheal dyskinesia;
2. Normalization of pathological ventilation-perfusion
irregularities and optimization of gas exchange;
3. The anti-inflammatory action, realized through decrease in
free-radical oxidation of lipids, as a result of hypercapnic action of
the device TDI-01, which accelerates achievement of clinical remission.
Disclosure of other mechanisms of influence of the breathing device
TDI-01 (the Frolov breathing device) on the respiratory system of the
patients with bronchial asthma and confirmation of our data require
conduction of further in-depth investigations including dynamic
spirometry (peak flow measurements), definition of reactivity of
airways on a background of application of the respiratory breathing
device (Frolov) and the analysis of a complex homeostatic systems of an
organism (including the protease inhibiting balance). We believe that
the use of the device TDI-01 is promising in treatment of bronchial
asthma and, especially, in cases when it is accompanied by a
hyperventilation syndrome, as well as for the patients with chronic
obstructive bronchitis and emphysema of the lungs.
/ Translated by Artour Rakhimov, December 2010
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