Akash Balki1, S Balamurugan2, Suhas Bardapurkar3, Sonia Dalal4, Ajeet Singh5, B P Singh6, Abhijit Vaidya7, Jaideep A Gogtay8. 1. Chest Care Hospital, Sakkardara Square, Umred Road, Nagpur, India. Electronic address: akash_balki@yahoo.com. 2. Dr. Balamurugan's Chest Clinic, No.2, 1st Cross Street, Janaki Nagar Extn., Valasaravakkam, Chennai, 600 087, India. Electronic address: dr.s.bala@gmail.com. 3. Shree Nursing Home, 15, Sujay, Sanmitra Colony, Near Daily Marathwada, Aurangabad, 431 001, India. Electronic address: drsuhasbardapurkar@gmail.com. 4. Ashray Chest Center, 101-102, Shree Hari Complex, Anand Society, Vadodara, 390007, India. Electronic address: drsoniadalal@hotmail.com. 5. Asthma Bhawan, R-3, Sector - 6, Near Cinestar, Vidhyadhar Nagar, Jaipur, 302023, India. Electronic address: dr.ajeetsingh@yahoo.com. 6. Surya Chest Foundation, 16/1326, Indra Nagar, Lucknow, 226 016, India. Electronic address: bps2159@yahoo.com. 7. Medical Services, Cipla Limited, Mumbai, India. Electronic address: abhijit.vaidya@cipla.com. 8. Cipla Limited, Mumbai, India. Electronic address: jgogtay@cipla.com.
Abstract
BACKGROUND: Combination therapy of inhaled corticosteroid/long acting β2-agonist (ICS/LABA) is the cornerstone of managing asthmatics who are uncontrolled with low-medium dose of ICS. The novel ICS/LABA combination of fluticasone propionate and formoterol (flu/form) provides potent anti-inflammatory and rapid bronchodilatory effect. This randomized, multi-centre, double-blind study compared the efficacy and safety of flu/form (125/6 mcg BD; Maxiflo®) with the well-established budesonide/formoterol combination (bud/form 200/6 mcg BD), both delivered through a pressurized metered dose inhaler (pMDI) in patients with moderate to severe persistent asthma over 12 weeks. METHODS: This study enrolled patients between 18 and 65 years. The primary end-point was to demonstrate non-inferiority for the mean change in the pre-dose morning peak expiratory flow values (PEF). The secondary end-points included lung function assessments, number of symptom-free days and nights, rescue medication use, day-and night-time symptom scores and safety evaluation. RESULTS:Two hundred and thirty-two patients were randomized to either flu/form (n = 117) or bud/form (n = 115). At the end of 12 weeks, flu/form was non-inferior to bud/form with regards to the primary end-point of morning PEF (48.07 L/min vs. 49.03 L/min, p > 0.05). These improvements were statistically significant (p < 0.0001) vs baseline. Similar improvements were observed between the two groups for secondary efficacy end-points including FEV1, symptom-free nights, rescue medication use, day-and night-time symptom scores (p > 0.05). Flu/form exhibited a safety profile comparable to that of bud/form. CONCLUSION:Fluticasone/formoterol combination administered through a pMDI is as efficacious and well-tolerated as budesonide/formoterol and offers a new therapeutic option for patients with moderate to severe persistent asthma.
RCT Entities:
BACKGROUND: Combination therapy of inhaled corticosteroid/long acting β2-agonist (ICS/LABA) is the cornerstone of managing asthmatics who are uncontrolled with low-medium dose of ICS. The novel ICS/LABA combination of fluticasone propionate and formoterol (flu/form) provides potent anti-inflammatory and rapid bronchodilatory effect. This randomized, multi-centre, double-blind study compared the efficacy and safety of flu/form (125/6 mcg BD; Maxiflo®) with the well-established budesonide/formoterol combination (bud/form 200/6 mcg BD), both delivered through a pressurized metered dose inhaler (pMDI) in patients with moderate to severe persistent asthma over 12 weeks. METHODS: This study enrolled patients between 18 and 65 years. The primary end-point was to demonstrate non-inferiority for the mean change in the pre-dose morning peak expiratory flow values (PEF). The secondary end-points included lung function assessments, number of symptom-free days and nights, rescue medication use, day-and night-time symptom scores and safety evaluation. RESULTS: Two hundred and thirty-two patients were randomized to either flu/form (n = 117) or bud/form (n = 115). At the end of 12 weeks, flu/form was non-inferior to bud/form with regards to the primary end-point of morning PEF (48.07 L/min vs. 49.03 L/min, p > 0.05). These improvements were statistically significant (p < 0.0001) vs baseline. Similar improvements were observed between the two groups for secondary efficacy end-points including FEV1, symptom-free nights, rescue medication use, day-and night-time symptom scores (p > 0.05). Flu/form exhibited a safety profile comparable to that of bud/form. CONCLUSION:Fluticasone/formoterol combination administered through a pMDI is as efficacious and well-tolerated as budesonide/formoterol and offers a new therapeutic option for patients with moderate to severe persistent asthma.