Health-related quality of Life (HRQoL) has been considered an important variable to be managed in airway diseases. Asthma reduce HRQoL as a result of profound physical and psychosocial complications. Asthma HRQoL questionnaire is a disease-specific 32-item instrument including 4 domains: symptoms, emotions, exposure to environmental stimuli and activity limitations. Patients rate the impairments experienced during the previous 14 days and respond on 7-point scale. It was used to assess the improvement in HRQoL after treatment in asthmatics. Mometasone being newer drug has low systemic bioavailability, high glucocorticoid receptor affinity and modifies inflammatory mediators involved in the pathogenesis of asthma. Mometasone significantly improves lung function and symptom control in asthmatics when used in combination with Formoterol. Hence the present study was under taken to compare the HRQoL between Mometasone group (Mometasone & Formoterol) versus Fluticasone group (Fluticasone& Formoterol) using DPI.
Methods: The present study was conducted in PMU, Bangalore during March 2011 to February 2012. 60 patients were recruited in each arm based on inclusion and exclusion criteria. PFT was done pre and post bronchodilator with Salbutamol nebulization. Study medications were randomized, double blinded and was given for 12weeks. HRQoL questionnaire was administered before and after the medications and outcome was compared between them. Statistical test used - descriptive statistics, Z- test, t- test
Results:
Majority i.e., 20(33.33%) patients were in the age group of 31-40years in Fluticasone group whereas in Mometasone group majority i.e., 22(36.67%) were of the same age group. 18(30.00%) in Fluticasone group belonged to upper socio economic status, whereas 17(28.33%) were in lower middle class in Mometasone group. 22(36.67%) were graduates in Fluticasone group, 22(36.67%) in Mometasone were educated up to PUC. 21(35.00%) were self-employed in Fluticasone group whereas 23(38.33%) were housewives in Mometasone group. There was a significant improvement in HRQoL from baseline to the end of 12 weeks in all domains in both the groups (P=0.001) but the overall improvement in the HRQoL was not significant when compared between the groups which revealed both combinations were equally effective.
Conclusions:
Both Mometasone+ Formetrol and Fluticasone+ Formetrol combinations are equally effective in improving HRQoL in asthmatics.