COMPARATIVE STUDY OF TREATMENT, EFFICACY AND ADVERSE EFFECTS OF COMMONLY PRESCRIBED DRUGS IN THE MANAGEMENT OF ASTHMA

BACKGROUND: Asthma is a chronic inflammatory airway disease affecting millions worldwide, including ~35 million Indians.[1] It is managed with various drug classes: inhaled corticosteroids (ICS), long-acting β₂-agonists (LABA), leukotriene receptor antagonists (LTRA) and methylxanthines (theophylline/doxofylline). Current guidelines recommend low-dose ICS as first-line controller therapy, with add-on LABA or LTRA if control is inadequate.[2] However, prescribing patterns often vary, and relative efficacy/adverse profiles of these options require comparison. This study compared four commonly used regimens – ICS alone, ICS+LABA, Montelukast (LTRA), and Theophylline (doxofylline) – in moderate persistent asthma. MATERIALS AND METHODS: In a prospective, open-label study, 200 patients with moderate persistent asthma (age 18–65) were randomized into four groups (n=50 each). Group A received inhaled Budesonide 400 µg twice daily; Group B received Budesonide 200 µg + Formoterol 12 µg twice daily; Group C received oral Montelukast 10 mg nightly; Group D received oral doxofylline 400 mg twice daily. All patients continued as-needed salbutamol. Treatment lasted 12 weeks. Primary outcomes were change in FEV₁ and Asthma Control Test (ACT) score. Secondary outcomes included symptom frequency, rescue use, and adverse events. Data were analyzed by ANOVA and chi-square tests (significance p<0.05). RESULTS: Baseline characteristics (age ~42±13 years, 52% male, FEV₁ ~2.05 L, ACT ~17) were similar across groups (p>0.05). Efficacy: Group B (ICS+LABA) showed the greatest improvement (FEV₁ ↑0.29 L, ACT +4.2), significantly higher than Group A (ICS only: FEV₁ ↑0.18 L, ACT +3.0; p<0.05) and Group C (Montelukast: FEV₁ ↑0.12 L, ACT +2.4; p<0.01). Group D (Theophylline) had intermediate gains (FEV₁ ↑0.23 L, ACT +3.5) comparable to Group A (p>0.1). These findings align with prior reports of combination ICS/LABA superiority and Theophylline+ICS being as effective as higher ICS doses. Adverse Effects: Group A had mild oropharyngeal candidiasis in 4% (managed by rinsing). Group B reported palpitations/tremor in 12% (consistent with LABA class effects). Group C had transient headache or insomnia in 8%, with no severe neuropsychiatric events noted (though meta-analyses warn of modest anxiety risk with Montelukast). Group D experienced nausea or restlessness in 10%. No severe events (arrhythmia, seizures) occurred, reflecting known Theophylline safety at moderate doses. The incidence of any adverse event was highest in Group B (16%) and Group D (12%), vs Group A (5%) and Group C (8%). Results are summarized in Tables 1–3 and Figures 1–3. CONCLUSION: In moderate asthma, adding a LABA to ICS provides the greatest clinical benefit. ICS monotherapy and theophylline add-on gave moderate improvement, while Montelukast alone was least effective. All treatments were generally well tolerated. Combination ICS/LABA should be preferred when asthma remains uncontrolled, while costeffective alternatives (e.g. theophylline) may be used cautiously if needed. Recognizing each drug’s efficacy and side-effect profile helps optimize therapy.