European Journal of Cardiovascular Medicine

Bronchial asthma is a chronic inflammatory airway disorder characterized by variable and recurring symptoms, airflow obstruction, bronchial hyperresponsiveness, and underlying inflammation. ^[1] It affects approximately 300 million individuals globally, with a rising trend in the pediatric age group. ^[2] In India, the prevalence among children is estimated to be between 5% and 15%.^[3]

Asthma in children not only poses significant morbidity but also imposes a substantial socioeconomic burden due to recurrent hospitalizations, absenteeism from school, and long-term medication use. ^[4] The mainstay of asthma management is pharmacological therapy aimed at achieving symptom control and minimizing exacerbations. Inhaled corticosteroids (ICS), short-acting β2-agonists (SABA), long-acting β2-agonists (LABA), leukotriene receptor antagonists (LTRAs), and anticholinergics constitute the cornerstone of pediatric asthma pharmacotherapy. ^[5]

Despite the well-established efficacy of these medications, pediatric patients are particularly vulnerable to adverse drug reactions (ADRs) due to differences in drug metabolism, dosing, and compliance issues. ^[6] ADRs may range from mild effects such as oral thrush and hoarseness to severe events like adrenal suppression and growth retardation associated with chronic corticosteroid use. ^[7] Additionally, improper inhalation techniques and poor adherence exacerbate both therapeutic inefficacy and the likelihood of ADRs. ^[8]

Pharmacovigilance in pediatric populations is crucial but often underreported, especially in resource-constrained settings. ^[9] With asthma management shifting toward precision medicine and individualized therapy, understanding the safety profiles of asthma drugs in real-world clinical scenarios becomes increasingly important. ^[10] In children, where the immune system and physiological parameters are still maturing, drug tolerance and adverse effect profiles may significantly differ from adults. ^[11]

Moreover, the World Health Organization emphasizes the need for proactive ADR monitoring systems, particularly in chronic diseases like asthma where multiple drugs are used for extended periods. ^[12] Therefore, this study aims to bridge the knowledge gap by prospectively evaluating the pharmacotherapy patterns and associated adverse drug reactions in pediatric asthma patients attending a tertiary care hospital.

Through systematic monitoring of prescribed medications and vigilant documentation of any adverse events, this study intends to provide insights into drug safety, optimize therapeutic regimens, and enhance overall asthma care in pediatric populations. The results could also inform policy changes regarding pediatric ADR surveillance and contribute to existing literature in this domain.

This prospective observational study was conducted in the Department of Pediatrics and Pharmacology at a tertiary care hospital over a period of 12 months. The primary objective was to evaluate the patterns of pharmacotherapy in bronchial asthma among pediatric patients and to identify and analyze the adverse drug reactions (ADRs) associated with these treatments.

Study Design and Setting

The study adopted a prospective, hospital-based observational design. Data were collected from both outpatient and inpatient pediatric units of the hospital. Ethical clearance was obtained from the Institutional Ethics Committee prior to initiation, and written informed consent was obtained from parents or legal guardians of all participants.

Inclusion Criteria

• Pediatric patients aged between 1 and 14 years.
• Diagnosed cases of bronchial asthma as per Global Initiative for Asthma (GINA) guidelines.
• Patients who were prescribed one or more anti-asthmatic drugs (inhaled or systemic).
• Patients whose caregivers provided written informed consent.
• Willingness to participate in follow-up assessments over the study period.

Exclusion Criteria

• Children with chronic pulmonary diseases other than asthma (e.g., cystic fibrosis, bronchiectasis).
• Patients with immunodeficiency syndromes or congenital heart diseases.
• Cases where anti-asthmatic therapy was initiated elsewhere before presentation.
• Patients with incomplete medical records or who were lost to follow-up.
• Caregivers not willing to participate or unable to communicate adequately.

Data Collection

A pre-designed structured proforma was used to collect the following details:

• Demographic data: Age, gender, residence, family history of asthma, environmental exposure (e.g., smoking, pets, dust).
• Clinical details: Symptoms, frequency of attacks, severity, comorbidities, and previous hospitalizations.
• Pharmacotherapy: Type of drugs used (inhaled corticosteroids, β2-agonists, LTRAs, anticholinergics, theophyllines), route of administration, dosage, and frequency.
• Adverse Drug Reactions: ADRs were identified based on clinical examination, caregiver reports, and investigations, if needed. All suspected ADRs were evaluated using the WHO-Uppsala Monitoring Centre (WHO-UMC) causality assessment scale to categorize them into certain, probable, possible, or unlikely.

Monitoring and Follow-up

Patients were followed throughout their hospital stay or during monthly outpatient visits for up to three months. During each visit, adherence, drug tolerance, and the emergence of new ADRs were assessed. Specific emphasis was placed on detecting ADRs related to long-term corticosteroid use (e.g., oral candidiasis, growth suppression) and β2-agonists (e.g., tachycardia, tremors).

Statistical Analysis

Data were entered in Microsoft Excel and analyzed using SPSS version 22.0. Categorical variables were expressed as frequencies and percentages. Continuous variables were presented as mean ± standard deviation (SD). The incidence of ADRs was calculated, and associations between drug classes and specific ADRs were evaluated using Chi-square tests. A p-value < 0.05 was considered statistically significant

Table 1: Age-wise Distribution of Pediatric Asthma Patients

In table 1, the majority of pediatric asthma cases were in the 7–10 years age group (30%), suggesting increased diagnosis and drug exposure during school years when environmental triggers and activity levels are higher.

Table 2: Gender-wise Distribution

In table 2, there was a male predominance (63.3%) in asthma incidence, consistent with global trends in pediatric asthma due to gender-based anatomical and hormonal differences influencing airway hyperreactivity.

Table 3: Drug Prescription Pattern

In table 3, SABA (especially salbutamol) was the most frequently prescribed agent (93.3%), followed by inhaled corticosteroids.

Table 4: Types of Adverse Drug Reactions Observed

Table 5: Severity of Adverse Drug Reactions

In table 5, Most ADRs were mild to moderate (93.6%), indicating manageable side effects.

Table 6: Causality Assessment (WHO-UMC Scale)

In table 6, Most ADRs were classified as "Probable" (42.5%) or "Possible" (38.3%), indicating a moderate level of evidence linking the ADR to the drug. Only 10.6% were confirmed as “Certain,” emphasizing the diagnostic challenges in pediatric ADR surveillance.

The current study assessed the incidence, prevalence, and The current prospective study provides comprehensive insight into the pharmacotherapy patterns and adverse drug reactions (ADRs) observed in pediatric patients with bronchial asthma at a tertiary care center. The findings align with established trends and further highlight the need for vigilant ADR monitoring in this vulnerable population.

The age distribution revealed a predominance of asthma cases in the 7–10 year age group, consistent with global data suggesting increased disease recognition and environmental exposure during school years. ^[13] The observed male predominance (63.3%) is also supported by previous studies, which attribute this to smaller airway diameters, hormonal influences, and genetic susceptibility among boys. ^[14]

In terms of pharmacotherapy, short-acting β2-agonists (SABA), primarily salbutamol, were the most frequently prescribed drugs (93.3%), followed by inhaled corticosteroids (ICS), prescribed to 80% of the study population. This is in agreement with GINA guidelines and other Indian studies, ^[15] which confirm SABA and ICS as the mainstays of asthma management. Leukotriene receptor antagonists (LTRAs), LABAs, anticholinergics, and methylxanthines were used less frequently, reflecting a stepwise approach in therapy as per severity.

A total of 47 ADRs were reported among 150 patients, with the majority attributed to salbutamol and inhaled corticosteroids. Common ADRs such as tremors, palpitations, and oral candidiasis have been previously reported in literature. ^[16] Oral candidiasis, in particular, is a known complication of prolonged ICS use, especially without proper mouth rinsing. ^[17]

Growth retardation, though reported in only four cases, deserves special attention. Chronic ICS therapy, especially in pre-pubertal children, has been linked to growth suppression due to systemic steroid absorption. ^[18] Studies by Allen et al. ^[19] and others indicate that while low-dose ICS are generally safe, regular growth monitoring remains crucial.

The ADR severity profile in our study showed that 55.3% were mild and 38.3% were moderate, which is consistent with reports by Biswal et al. ^[20] and Narayanan et al. ^[21] Only 6.4% of ADRs were severe, indicating that most side effects were manageable with dose modification or supportive care.

Causality assessment using WHO-UMC scale revealed that 42.5% of ADRs were "Probable," and 38.3% were "Possible." Similar causality patterns have been noted in pediatric ADR studies conducted in Mumbai and Chandigarh. ^[23] However, a major limitation remains underreporting and difficulty in linking ADRs with specific drugs in multi-drug regimens.

Another important observation was the incorrect inhaler technique and lack of patient/caregiver education, which may potentiate both therapeutic failure and ADRs. Educational interventions and routine demonstrations have been shown to improve outcomes and minimize ADRs. ^[24].

The identification of ADRs such as oral candidiasis, tremors, palpitations, and growth retardation emphasizes the necessity of individualized therapy, correct inhalation techniques, and regular follow-up. Furthermore, pharmacovigilance should be strengthened in pediatric practice, especially in resource-limited settings where underreporting is common. Caregiver counseling, monitoring drug safety, and adherence to asthma action plans are essential components of holistic pediatric asthma management. Future multicentric studies with larger cohorts and longer follow-up durations are warranted to generate more conclusive data on long-term safety profiles in children.

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