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\begin{document}

\title{Usage of a Novel Inhaler Device for the Management of Asthma in Children
with Special Needs}



\author[1]{Bharath Reddy}%
\affil[1]{Shishuka Children's Specialty Hospital}%


\vspace{-1em}



  
  \date{June 08, 2024}


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\selectlanguage{english}
\begin{abstract}
Dear Editor, I am writing to submit a letter titled ``Usage of a Novel
Inhaler Device for the Management of Asthma in Children with Special
Needs'' for your consideration. This letter highlights the importance of
the inhaler device technique in children with asthma when they have
comorbid conditions such as attention-deficit/hyperactivity disorder
(ADHD) and/or autism spectrum disorder (ASD). These comorbidities often
make it challenging for physicians to plan a treatment regimen, as it
impacts the patient's adherence to medication. We evaluated the
effectiveness of a breath-actuated inhaler (BAI) in managing poorly
controlled asthma in three pediatric patients with special needs. All
patients showed significant improvement in their asthma symptoms, were
well-controlled after one month of using the BAI and they found that
device was easy to use. This letter contributes to the growing body of
evidence supporting the effectiveness of BAI in the management of
asthma, particularly in children with special needs. We hope this work
to be submitted under the letter to editor section and it will be of
interest to your readership and contribute to improving asthma
management in children with comorbidities. Thank you for your
consideration.%
\end{abstract}%



\sloppy


Title: Usage of a Novel Inhaler Device for the Management of Asthma in
Children with Special Needs

Type of manuscript: Letter to the editor

\textbf{Author}

Dr. K. R. Bharath Kumar Reddy,

\textbf{Affiliations}

Consultant Pediatric Pulmonologist, Pediatric Pulmonology and Sleep,

Shishuka Children's Specialty Hospital, Bangalore, India

Email id- drbharathreddykr@gmail.com

https://orcid.org/0000-0001-9074-6743

\textbf{Correspondence:}

Dr. K. R. Bharath Kumar Reddy, Consultant Pediatric Pulmonologist,
Pediatric Pulmonology and Sleep, Shishuka Children's Specialty Hospital,
Bangalore, India

Email id- drbharathreddykr@gmail.com, Phone- +91 98451 38419

\textbf{To the Editor,}

Asthma is a prevalent health condition (incidence rate
\textasciitilde{}7.9\%) among children in India. Besides leading to
insufficient sleep, exhaustion, and steady deterioration in lung
function, poorly controlled asthma makes it extremely difficult for
these children to participate in some of the daily outdoor
activities\textsuperscript{1}. Further, it is the third most common
reason for children being hospitalized and accounts for more than 10
million `lost school days' annually\textsuperscript{1}.

An overlap between asthma, attention-deficit/hyperactivity disorder
(ADHD), and/or autism spectrum disorder (ASD) has been reported in
children\textsuperscript{2}. Kaas et al. found in a systematic review
that out of 25 asthma-ADHD studies, 17 studies revealed a significant
positive association, while one study showed a negative association.
Asthma is more common in children with ASD, reportedly 21.6\% of
children with ASD were diagnosed with asthma of which 49.5\% reported an
acute exacerbation of asthma over 12 months. As such comorbidities are
usually associated with complex clinical management, increased economic
burden, and complex health outcomes, the presence of ADHD/ASD with
asthma is challenging for patients and physicians. ASD is typically
characterized by severe functional impairment, poor social interaction,
and repetitive or stereotypical behavior, while ADHD is associated with
functional impairment, poor cognitive development, and
hyperactive-impulsive responses\textsuperscript{3,4}. These
characteristics in either of the conditions, in addition to asthma,
present challenges to physicians in planning a treatment regimen, as it
impacts the patient's adherence to medication.

Inhalation therapy is the key to effective asthma management. Delivering
inhaled medications directly to the lungs has the advantage of the drug
being delivered more effectively to the airways along with reduced
systemic adverse effects.\textsuperscript{5} Use of the appropriate
device(s) and patient preference for the device are critical for patient
adherence which in turn plays an important role in controlling symptoms
and thereby improving the quality of life in such
patients\textsuperscript{5}. Inhaler devices, including pressurized
metered-dose inhalers (pMDIs) with or without added spacers, and dry
powder inhalers (DPIs), are widely used to deliver medications directly
to the lungs. However, these have certain disadvantages which limit
their use by physicians and patients. Breath-actuated inhalers (BAI)
have been recently introduced which overcome some of the drawbacks of
pMDIs and DPIs.\textsuperscript{5}

We evaluated the effectiveness of BAI in the management of asthma in
three such pediatric patients between the age of 10-13 years who
reported asthma exacerbations and poorly controlled symptoms. Two of
them had severe ADHD while one was a child with autistic spectrum
disorder (ASD) with ADHD. Previously, one child was treated with
budesonide (100 \selectlanguage{greek}µ\selectlanguage{english}g) twice a day with pMDI plus spacer, while the other
two children were treated with fluticasone (100 \selectlanguage{greek}µ\selectlanguage{english}g) plus salmeterol (25
\selectlanguage{greek}µ\selectlanguage{english}g) pMDI plus spacer, two puffs twice a day. All three patients were
referred in view of poor control of symptoms with frequent exacerbations
over 6 months with a low score on the asthma control test. While
evaluating the technique of the drug delivery, all three patients were
not cooperating sufficiently to take a minimum of six breaths with the
pMDI plus spacer. After obtaining consent from the parents, all children
were started on inhaled fluticasone (100) plus salmeterol (25) given via
BAI (Synchrobreathe\selectlanguage{ngerman}®) for a period of one month with levosalbutamol BAI
(Levolin®) as a reliever. Following the use of BAI, all patients
improved on their asthma control test scores and were well controlled.
Further evaluation using a patient satisfaction questionnaire revealed
that the parents reported that BAI was easier to use, required lesser
effort for breathing, children had a better understanding of using the
device and was easier to maintain. All children followed up for 3 months
and were well controlled with no need for using reliever medication
during this period. This observation highlights the importance of
technique of inhaler use in children with special needs.

In our study, we saw the key advantages of BAI which included overcoming
the challenge of patient coordination of actuation with breathing, as
BAI detects an inhalation attempt through the actuator and mechanically
actuates the dosage in synchronization. This eliminates the need for
pressing and breathing, which thereby removes technical dependency. BAI
is compact, portable and obviates the need of a spacer. It provides the
advantage of ease of use and assurance of a consistent dosage every time
children use it, as it requires a low inspiratory flow rate for breath
actuation. Decreased oropharyngeal deposition and increased lung
deposition have also been noted with BAIs as the drug is released at a
lower velocity.\textsuperscript{5} BAIs are also easy to clean and
maintain.

In a study conducted in 51 children hospitalized with an acute
exacerbation, more number of children could activate a BAI as compared
to a DPI. Moreover, children with wheeze under 6 years of age, who were
inept at using the DPI, showed a worthwhile response to the
BAI.\textsuperscript{5}

Previously a few adult studies have demonstrated the advantages of BAI.
In a prospective study, 10 stable adult patients with asthma were
administered one puff of radiolabelled (99mTC) salmeterol and
fluticasone propionate (SFC) (25/125 mcg) via either a BAI
(Synchrobreathe®) or conventional pMDI and it was found that drug
deposition in the lungs was significantly higher with
Synchrobreathe®(22.33\%) as compared with the conventional pMDI
(17.32\%).\textsuperscript{6}

Due to the cognitive, physical, and sensory disabilities and device
disadvantages stated above, children suffering from ADHD and ASD are
likely to face difficulties in using their inhaler devices correctly,
resulting in poor disease control. More studies are needed on newer
inhalation devices in children with special needs. It is important to
map the advantages of inhaler devices in terms of patient choice,
satisfaction, and simplicity of use in addition to enhanced medication
administration, less waste, and improved adherence. Guidelines must be
established to determine patient groups that will benefit from a certain
type of device. Based on the experience with these three pediatric cases
with special health care needs, the authors recommend BAIs to be
considered in treating asthma in patients with ASD and ADHD, given the
growing number of children with these conditions.

References

\begin{enumerate}
\tightlist
\item
  Daniel RA, Aggarwal P, Kalaivani M, Gupta SK. Prevalence of asthma
  among children in India: A systematic review and meta-analysis. Lung
  India 2022;39(4):357-367.
\item
  Coghill DR, Banaschewski T, Bliss C, Robertson B, Zuddas A. Cognitive
  function of children and adolescents with
  attention-deficit/hyperactivity disorder in a 2-year open-label study
  of lisdexamfetamine dimesylate. CNS Drugs 2018;32(1):85-95.
\item
  Lu S, Sonney J, Kieckhefer GM. Asthma management in children with
  autism spectrum disorders: pearls for a successful clinical encounter.
  J Pediatr Health Care 2014;28(6):559-564.
\item
  Kaas TH, Vinding RK, Stokholm J, Bønnelykke K, Bisgaard H, Chawes BL.
  Association between childhood asthma and attention deficit
  hyperactivity or autism spectrum disorders: A systematic review with
  meta-analysis. Clin Exp Allergy 2021;51(2):228-252.
\item
  Salvi S, Gogtay J, Aggarwal B. Use of breath-actuated inhalers in
  patients with asthma and COPD - an advance in inhalational therapy: a
  systematic review. Expert Rev Respir Med 2014;8(1):89-99.
\item
  Gogtay J, Tambe A, Rote K, Malhotra G, Sharma BG, Bhatnagar A,\emph{et
  al} . Improvement in the drug delivery of salmeterol/fluticasone via a
  novel breath actuated pressurized metered dose inhaler with a dose
  counter. Eur Respir J. Sep 2019, 54 (suppl 63) PA4222.
\end{enumerate}

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