Fixed-Dose Inhaler Combinations for COPD Treatment in India
Available Triple Therapy Combinations
India was the first country to approve fixed-dose triple combination therapy for COPD, with beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FOR/GLY) being the pioneering triple inhaler approved in the Indian market 1.
Currently available fixed-dose triple combinations (ICS/LAMA/LABA) in India include:
Beclomethasone dipropionate/Formoterol fumarate/Glycopyrronium bromide (BDP/FOR/GLY) - extrafine formulation that demonstrated reduced exacerbation risk, improved lung function, and favorable health status compared to dual therapy 2, 3
Fluticasone furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) - showed protective effects against COPD exacerbations with improved lung function outcomes 3, 4
Budesonide/Glycopyrronium bromide/Formoterol fumarate (BUD/GLY/FOR) - demonstrated comparable efficacy to other triple combinations in reducing exacerbations and improving lung function 3, 4
Dual Bronchodilator Combinations (LABA/LAMA)
For patients with moderate-to-high symptom burden (CAT ≥10, mMRC ≥2) and FEV1 <80%, dual bronchodilator therapy (LABA/LAMA) represents the preferred initial approach before escalating to triple therapy 5, 6.
Available LABA/LAMA combinations include:
Indacaterol/Glycopyrronium - 24-hour acting combination with superior exacerbation prevention compared to 12-hour LABAs 7
Formoterol/Glycopyrronium - available in multiple formulations 2
Vilanterol/Umeclidinium - once-daily combination 2
Olodaterol/Tiotropium - 24-hour bronchodilation 7
ICS/LABA Dual Combinations
ICS/LABA combinations should be reserved specifically for patients with asthma-COPD overlap, as they increase pneumonia risk without clear benefit in pure COPD patients without exacerbation history 5, 6.
Available ICS/LABA combinations:
Recommended Dosing Regimens by Clinical Scenario
For Low Symptom Burden (Group A: CAT <10, mMRC 0-1, FEV1 ≥80%)
Start with single long-acting bronchodilator (LAMA or LAMA) once daily, with LAMA slightly preferred for superior exacerbation prevention 5, 6
All patients should have short-acting bronchodilator available as needed for breakthrough symptoms 5
For High Symptoms, Low Exacerbation Risk (Group B: CAT ≥10, mMRC ≥2, FEV1 <80%, <2 exacerbations/year)
Initiate LABA/LAMA dual bronchodilator therapy once daily as first-line treatment 5, 6
If persistent breathlessness on monotherapy, escalate from single agent to LABA/LAMA combination 5
For High Exacerbation Risk (Group D: ≥2 moderate or ≥1 severe exacerbation/year)
Single-inhaler triple therapy (LAMA/LABA/ICS) once daily is strongly recommended as it reduces mortality with moderate certainty of evidence 5, 6
Triple therapy dosing: BDP/FOR/GLY 87/5/9 mcg two inhalations twice daily, or FF/UMEC/VI 100/62.5/25 mcg one inhalation once daily, or BUD/GLY/FOR 320/18/9.6 mcg two inhalations twice daily 2, 3, 4
Blood Eosinophil-Guided Escalation Strategy
For patients with eosinophils <100 cells/μL on LABA/LAMA experiencing exacerbations, do not escalate to triple therapy; instead add oral therapies (azithromycin or roflumilast) 5.
For patients with eosinophils ≥300 cells/μL on LABA/LAMA who develop exacerbations, escalate to triple therapy (LABA/LAMA/ICS) 5, 6.
Special Considerations for Indian Population
The Indian COPD population has unique characteristics including high burden of exacerbating disease, significant nonsmoker COPD prevalence, and frequent asthma-COPD overlap, which may necessitate earlier optimization to single-inhaler triple therapy compared to Western populations 8.
Key factors supporting early triple therapy in India:
High prevalence of biomass fuel exposure causing COPD in nonsmokers 8
Overlapping asthma-COPD phenotypes requiring ICS component 8
Poor adherence to multiple inhaler regimens, making single-inhaler triple therapy advantageous 8
Critical Pitfalls to Avoid
Never use ICS monotherapy in COPD as it increases pneumonia risk without exacerbation benefit 5, 6
Do not prescribe ICS-containing regimens to low-risk patients without documented exacerbation history 5
Avoid prescribing multiple devices with different inhalation techniques, which increases exacerbations and medication errors 5
In high-risk exacerbators, starting with dual therapy and waiting for further exacerbations delays the mortality benefit of triple therapy 5
Monitor for increased pneumonia risk with ICS-containing regimens, particularly in patients with eosinophils <100 cells/μL 5, 6