Salmeterol/fluticasone through breath-actuated inhaler versus pMDI: a randomized, double-blind, 12 weeks study.
OBJECTIVE
Salmeterol/fluticasone combination (SFC) formulated in a breath-actuated inhaler (BAI) overcomes the co-ordination problem associated with the pressurized-metered dose inhaler (pMDIs). Our aim was to compare the efficacy and the safety of SFC given through the BAI versus the conventional pMDI in moderate-to-severe asthmatics.


METHODS
In this randomized, double-blind, double-dummy, prospective, active-controlled, parallel group, multicenter, 12 weeks study, 150 asthmatics were randomized to receive SFC (25/125 mcg) through either BAI or pMDI. The primary efficacy endpoint was mean change in pre-dose morning PEFR value at 12 weeks and the secondary efficacy endpoints included, mean change in FEV(1), pre-bronchodilator FVC, pre-dose morning and evening PEFR, symptom scores at 2, 4, 8, and 12 weeks. Patient preferences for device and safety were also assessed.


RESULTS
At 12 weeks, the mean change in pre-dose morning PEFR in BAI and pMDI groups was 50.72 L/min and 48.82 L/min, respectively (p < 0.0001; both groups) and the difference between the two groups was not significant. Both the treatment groups showed a statistically significant improvement in secondary endpoints at all-time points compared with baseline. The usability questionnaire assessment results showed that the BAI device was preferred by 75% of patients as compared with 25% preferring pMDI. SFC in both BAI and pMDI devices was found to be safe and well tolerated.


CONCLUSIONS
This is the first study to demonstrate that SFC given through the BAI produces comparable efficacy and safety endpoints as pMDI. Additionally, BAI was the preferred inhaler by patients compared to conventional pMDI.
a Department of Pulmonology and Critical Care , Fortis Hospital , Kolkata , India .
Raja
R
Dhar
b Chest Research Foundation , Pune , India .
Sundeep
S
Salvi
c The Bhatia General Hospital , Mumbai , India .
Sujeet
S
Rajan
d Ashray Chest Centre , Vadodara , India .
Sonia
S
Dalal
e Asthma Bhavan , Jaipur , India .
Sharad
S
Tikkiwal
f Dr. Bhagat's Allergy - Asthma Clinic & Respiratory Care Centre , Ahmedabad , India .
Raj
R
Bhagat
g Revival Chest Clinic , Aurangabad , India .
Mohammed Masood
MM
Ahmed
h Shree Hospital and Critical Care Centre , Nagpur , India .
Akash
A
Balki
i Swaash Clinic, Navkar Hospital , Jaipur , India , and.
Manish
M
Jain
j Cipla Ltd , Mumbai , India.
Jaideep
J
Gogtay
D000328:Adult; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D057240:Patient Preference; D011446:Prospective Studies; D012129:Respiratory Function Tests
D001993:Bronchodilator Agents; D000068297:Fluticasone-Salmeterol Drug Combination
Asthma; SFC BAI; SFC pMDI; Salmeterol/Fluticasone; breath-actuated inhaler; preference; pressurized metered dose inhaler