Asthma

Chronic inflammatory airway disease with episodes of reversible bronchoconstriction. Presents with dyspnea, wheezing, cough, and chest tightness.

ICD-10 J4516 drugs

Also known as: Bronchial asthma, Reactive airway disease

Drugs used for this condition

ABeclomethasone dipropionateFirst line · Inhaled corticosteroids (ICS)Asthma controller per GINA 2024. Starting dose 100–250 mcg twice daily, up to 500 mcg twice daily in severe asthma. Extra-fine HFA formulations (Qvar, Clenil) are considered equivalent to twice the dose of conventional CFC beclomethasone – important when converting and switching brands. Used as monotherapy or combined with formoterol.
ABudesonideFirst line · Inhaled corticosteroids (ICS)First-line controller for asthma in adults and children per GINA 2024. At GINA steps 1–2 in adults, GINA recommends as-needed low-dose budesonide/formoterol (anti-inflammatory reliever). At step 3, regular low- or medium-dose ICS combined with LABA (formoterol, salmeterol). ICS reduce asthma mortality per large meta-analyses. Starting dose 200 mcg twice daily.
ABudesonide/formoterolFirst line · Inhaled corticosteroid (ICS) plus long-acting β2-agonist (LABA) combination with rapid onsetFirst-line in the MART (maintenance and reliever therapy) strategy from GINA 2024 step 2. As-needed use in place of SABAs reduces exacerbation risk by 26–46% (SYGMA 1, SYGMA 2, Novel START). Standard regimen: 160/4.5 mcg twice daily plus 1 inhalation as needed for symptoms, up to 12 inhalations per day.
AFluticasoneFirst line · Inhaled and intranasal corticosteroidBronchial asthma in adults and children. Per GINA 2024, an inhaled corticosteroid is the backbone of controller therapy across all steps (1–5). Fluticasone propionate dose: 100–1000 µg/day in two doses for adults; 50–200 µg/day for children 4-16. Fluticasone furoate dose: 100–200 µg once daily. From GINA step 3 onward, use a fixed-dose ICS-LABA combination. Reassess symptoms and spirometry at 4–12 weeks; step down every 3–6 months when stable.
AFluticasone propionateFirst line · Inhaled corticosteroids (ICS)Asthma controller per GINA 2024. Regular twice-daily dosing. Mild-to-moderate asthma: 100–250 mcg twice daily; severe asthma: up to 500 mcg twice daily. Most patients are optimally treated with a fixed-dose combination with LABA (fluticasone/salmeterol, fluticasone/vilanterol). Children over 4 years: 50–200 mcg twice daily.
AFormoterolFirst line · Long-acting selective β2-agonist with rapid onset (rapid-onset LABA)In asthma formoterol is used only combined with an inhaled corticosteroid. GINA 2024 recommends ICS-formoterol (Symbicort, Fostair, Duoresp) in MART/SMART from step 1: a single inhaler used as needed for symptoms acts as both controller and reliever. The rapid onset (3–5 minutes) lets formoterol replace SABA in the reliever role. Isolated formoterol monotherapy in asthma is not used: the same risks described for salmeterol in the SMART trial apply. If formoterol was prescribed without an ICS as a stand-alone long-acting bronchodilator in asthma, consider seeking a second opinion.
AMometasoneFirst line · Inhaled, intranasal, and topical corticosteroidAsthma in adults and adolescents from 12 years. Per GINA 2024, inhaled corticosteroid is controller-therapy cornerstone. Mometasone furoate dose (Asmanex Twisthaler): 200–800 µg/day in 1–2 doses. Strong local effect allows once-daily dosing in mild-to-moderate asthma. Reassess symptoms and spirometry at 4–12 weeks.
APrednisoloneFirst line · GlucocorticoidsA short course of systemic corticosteroids (5–7 days) is the standard of care for moderate-to-severe asthma exacerbations per GINA. Prednisolone 40–50 mg daily in adults, 1–2 mg/kg in children. Start as early as possible during an exacerbation. Long-term systemic corticosteroid therapy for asthma is reserved for severe uncontrolled disease after all inhaled options are exhausted.
ASalmeterolAdd-on therapy · Long-acting selective β2-agonist (LABA, bronchodilator)Salmeterol is a LABA for asthma control only in fixed combination with an inhaled corticosteroid (ICS+LABA: Seretide, Aerivio, Plusvent). GINA 2024 and GEMA 5.4 from step 3 onward permit LABA only on top of ICS. Salmeterol monotherapy is not used in asthma: the SMART trial (Nelson 2006, over 26,000 patients) demonstrated increased asthma-related mortality. The FDA added a black-box warning for all LABAs in 2010; AEMPS issued a parallel safety note. If salmeterol was prescribed without an ICS as a stand-alone long-term bronchodilator or as a reliever for attacks, consider seeking a second opinion.
ASalmeterol + FluticasoneFirst line · Fixed-dose combination: long-acting beta-2 agonist (LABA) plus inhaled corticosteroid (ICS)Asthma at GINA step 3 and above – patients not controlled on low-to-medium ICS monotherapy. Per GINA 2024, fixed ICS-LABA is the backbone of steps 3–5 controller therapy. Salmeterol/fluticasone dose: 50/100, 50/250, 50/500 µg twice daily (Accuhaler/Diskus) or 25/50, 25/125, 25/250 µg as 2 inhalations twice daily (HFA inhaler). Reassess at 4–12 weeks; if stable for 3 months, step down to lower dose or drop LABA while keeping ICS.
ATiotropiumAdd-on therapy · Long-acting muscarinic antagonist for inhalation (LAMA)In severe asthma at GINA 2024 steps 4–5, tiotropium is added to ICS+LABA as triple therapy. Reduces exacerbation frequency and improves lung function. Not used as asthma monotherapy.
BMontelukastAdd-on therapy · Leukotriene receptor antagonistsAdd-on to ICS when asthma is uncontrolled at GINA step 2. As add-on therapy, it is inferior to LABAs (formoterol, salmeterol) per meta-analyses. Preferred in patients with comorbid allergic rhinitis or aspirin-exacerbated respiratory disease, where the leukotriene component of inflammation is more prominent.
BSalbutamol (Albuterol)Case-by-case decision · Short-acting beta-2 adrenergic agonists (SABA)Per GINA 2024, the preferred reliever in adults and adolescents from age 12 across all asthma steps is a fixed combination of low-dose ICS + formoterol (e.g., budesonide/formoterol) rather than salbutamol. SABA monotherapy is associated with increased asthma mortality (Cochrane meta-analysis). SABA use more than twice weekly is a marker of poor control. In children under 5, salbutamol remains the first-line reliever, with ICS added as a controller.
BTheophyllineThird line · MethylxanthineIn current GINA 2024 guidance, theophylline is reserve therapy at steps 4–5 of asthma management. Its bronchodilator effect is weaker than inhaled β2-agonists and its anti-inflammatory effect is weaker than inhaled corticosteroids. A narrow therapeutic window and multiple drug interactions limit use. ATS/ERS 2020 recommends theophylline only when foundational therapy is unavailable (no access to inhaled therapy, poor inhalation technique). Target blood concentration is 8–12 mcg/mL; some protocols accept up to 15 mcg/mL without toxicity symptoms.

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

How to read tiers A–F

Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit