{"id":"https://openalex.org/W4409366371","doi":"https://doi.org/10.5005/jp-journals-10003-1518","title":"Assessment of Efficacy and Safety of Fixed-dose Combination of Ebastine and Montelukast in the Management of Allergic Rhinitis in Indian Population in Comparison to Ebastine Monotherapy: A Randomized, Multicenter Study","display_name":"Assessment of Efficacy and Safety of Fixed-dose Combination of Ebastine and Montelukast in the Management of Allergic Rhinitis in Indian Population in Comparison to Ebastine Monotherapy: A Randomized, Multicenter Study","publication_year":2025,"publication_date":"2025-04-10","ids":{"openalex":"https://openalex.org/W4409366371","doi":"https://doi.org/10.5005/jp-journals-10003-1518"},"language":"en","primary_location":{"id":"doi:10.5005/jp-journals-10003-1518","doi":"https://doi.org/10.5005/jp-journals-10003-1518","is_oa":true,"landing_page_url":"https://doi.org/10.5005/jp-journals-10003-1518","pdf_url":"https://doi.org/10.5005/jp-journals-10003-1518","source":{"id":"https://openalex.org/S4210176693","display_name":"Otorhinolaryngology Clinics - An International Journal","issn_l":"0975-444X","issn":["0975-444X","0975-6957"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20","russia-white-list-4"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"An International Journal of Otorhinolaryngology Clinics","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"diamond","oa_url":"https://doi.org/10.5005/jp-journals-10003-1518","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5049776902","display_name":"Bachi T. Hathiram","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I3024917321","display_name":"Topiwala National Medical College & BYL Nair Charitable Hospital","ror":"https://ror.org/00d9qf519","country_code":"IN","type":"education","lineage":["https://openalex.org/I3024917321"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Bachi Hathiram","raw_affiliation_strings":["Department of ENT , TN Medical College and BYL Nair Charitable Hospital , Mumbai , Maharashtra , India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of ENT , TN Medical College and BYL Nair Charitable Hospital , Mumbai , Maharashtra , India","institution_ids":["https://openalex.org/I3024917321"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Neeraj N Mathur","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Neeraj N Mathur","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5109702850","display_name":"S Manjula","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Manjula S","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5014723696","display_name":"Krishna Kumar M","orcid":"https://orcid.org/0000-0001-6445-9476","observed_orcids":["https://orcid.org/0000-0001-6445-9476"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Krishna Kumar M","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5113188392","display_name":"CV Srinivas","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Srinivas CV","raw_affiliation_strings":["Department of ENT , Dr. B.R. Ambedkar Medical College , Bengaluru , Karnataka , India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of ENT , Dr. B.R. Ambedkar Medical College , Bengaluru , Karnataka , India","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5005845177","display_name":"B. V. Chandregowda","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Chandre Gowda BV","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5109333138","display_name":"Aloke Gopal Ghoshal","orcid":"https://orcid.org/0009-0005-0336-0524","observed_orcids":["https://orcid.org/0009-0005-0336-0524"]},"institutions":[{"id":"https://openalex.org/I4210149232","display_name":"National Allergy Asthma Bronchitis Institute","ror":"https://ror.org/049gvs161","country_code":"IN","type":"education","lineage":["https://openalex.org/I4210149232"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Aloke G Ghoshal","raw_affiliation_strings":["Department of ENT , National Allergy Asthma Bronchitis Institute , Kolkata , West Bengal , India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of ENT , National Allergy Asthma Bronchitis Institute , Kolkata , West Bengal , India","institution_ids":["https://openalex.org/I4210149232"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Rajesh A Chavan","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210142779","display_name":"Micro Labs (India)","ror":"https://ror.org/042pg9146","country_code":"IN","type":"company","lineage":["https://openalex.org/I4210142779"]},{"id":"https://openalex.org/I4210156439","display_name":"Noble Hospital","ror":"https://ror.org/05reefs64","country_code":"IN","type":"healthcare","lineage":["https://openalex.org/I4210156439"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Rajesh A Chavan","raw_affiliation_strings":["Department of ENT , Noble Hospital Pvt. Ltd. , Pune , Maharashtra , India","Department of Medical Services , Micro Labs Limited , Bengaluru , Karnataka , India,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of ENT , Noble Hospital Pvt. Ltd. , Pune , Maharashtra , India","institution_ids":["https://openalex.org/I4210156439"]},{"raw_affiliation_string":"Department of Medical Services , Micro Labs Limited , Bengaluru , Karnataka , India,","institution_ids":["https://openalex.org/I4210142779"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5117112243","display_name":"Sunita Bage","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I169117269","display_name":"Grant Medical College and Sir Jamshedjee Jeejeebhoy Group of Hospitals","ror":"https://ror.org/03dm1pq74","country_code":"IN","type":"education","lineage":["https://openalex.org/I169117269"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Sunita Bage","raw_affiliation_strings":["Department of ENT , Grant Govt. Medical College and Sir JJ Group of Hospitals , Mumbai , Maharashtra , India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of ENT , Grant Govt. Medical College and Sir JJ Group of Hospitals , Mumbai , Maharashtra , India","institution_ids":["https://openalex.org/I169117269"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5117112240","display_name":"Bimal K Mondol","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I111058918","display_name":"Calcutta National Medical College and Hospital","ror":"https://ror.org/02e2dtd78","country_code":"IN","type":"education","lineage":["https://openalex.org/I111058918","https://openalex.org/I226431899"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Bimal K Mondol","raw_affiliation_strings":[",","Department of ENT , Calcutta National Medical College , Kolkata , West Bengal , India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":",","institution_ids":[]},{"raw_affiliation_string":"Department of ENT , Calcutta National Medical College , Kolkata , West Bengal , India","institution_ids":["https://openalex.org/I111058918"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":6,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"16","issue":"3","first_page":"131","last_page":"135"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10877","display_name":"Allergic Rhinitis and Sensitization","score":0.9932000041007996,"subfield":{"id":"https://openalex.org/subfields/2723","display_name":"Immunology and Allergy"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10877","display_name":"Allergic Rhinitis and Sensitization","score":0.9932000041007996,"subfield":{"id":"https://openalex.org/subfields/2723","display_name":"Immunology and Allergy"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10051","display_name":"Asthma and respiratory diseases","score":0.00559999980032444,"subfield":{"id":"https://openalex.org/subfields/2740","display_name":"Pulmonary and Respiratory Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10634","display_name":"Food Allergy and Anaphylaxis Research","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/2723","display_name":"Immunology and Allergy"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/allergic-rhinitis","display_name":"allergic rhinitis","score":0.9670000076293945},{"id":"https://openalex.org/keywords/ebastine","display_name":"ebastine","score":0.984000027179718},{"id":"https://openalex.org/keywords/montelukast","display_name":"montelukast","score":1.0},{"id":"https://openalex.org/keywords/fixed-dose-combination","display_name":"fixed-dose combination","score":0.9900000095367432},{"id":"https://openalex.org/keywords/monotherapy","display_name":"monotherapy","score":0.6790000200271606},{"id":"https://openalex.org/keywords/nasal-congestion","display_name":"nasal congestion","score":0.5659999847412109},{"id":"https://openalex.org/keywords/sneezing","display_name":"sneezing","score":0.9919999837875366},{"id":"https://openalex.org/keywords/quality-of-life","display_name":"quality of life","score":0.8029999732971191},{"id":"https://openalex.org/keywords/rhinoconjunctivitis","display_name":"rhinoconjunctivitis","score":0.7950000166893005},{"id":"https://openalex.org/keywords/indian-population","display_name":"Indian population","score":0.5820000171661377},{"id":"https://openalex.org/keywords/drug-safety","display_name":"drug safety","score":0.6740000247955322},{"id":"https://openalex.org/keywords/adverse-events","display_name":"adverse events","score":0.5730000138282776}],"concepts":[{"id":"https://openalex.org/C2776623344","wikidata":"https://www.wikidata.org/wiki/Q5456317","display_name":"Fixed-dose combination","level":2,"score":0.8198305368423462},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7955087423324585},{"id":"https://openalex.org/C2776322731","wikidata":"https://www.wikidata.org/wiki/Q417767","display_name":"Montelukast","level":3,"score":0.7811596393585205},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.47786182165145874},{"id":"https://openalex.org/C42219234","wikidata":"https://www.wikidata.org/wiki/Q131130","display_name":"Anesthesia","level":1,"score":0.3629191517829895},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.3202885389328003},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.2719554305076599},{"id":"https://openalex.org/C2776042228","wikidata":"https://www.wikidata.org/wiki/Q35869","display_name":"Asthma","level":2,"score":0.18959933519363403}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.5005/jp-journals-10003-1518","doi":"https://doi.org/10.5005/jp-journals-10003-1518","is_oa":true,"landing_page_url":"https://doi.org/10.5005/jp-journals-10003-1518","pdf_url":"https://doi.org/10.5005/jp-journals-10003-1518","source":{"id":"https://openalex.org/S4210176693","display_name":"Otorhinolaryngology Clinics - An International Journal","issn_l":"0975-444X","issn":["0975-444X","0975-6957"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20","russia-white-list-4"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"An International Journal of Otorhinolaryngology Clinics","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.5005/jp-journals-10003-1518","doi":"https://doi.org/10.5005/jp-journals-10003-1518","is_oa":true,"landing_page_url":"https://doi.org/10.5005/jp-journals-10003-1518","pdf_url":"https://doi.org/10.5005/jp-journals-10003-1518","source":{"id":"https://openalex.org/S4210176693","display_name":"Otorhinolaryngology Clinics - An International Journal","issn_l":"0975-444X","issn":["0975-444X","0975-6957"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20","russia-white-list-4"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"An International Journal of Otorhinolaryngology Clinics","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":1.0}],"study_designs":[{"display_name":"Randomized Controlled Trial","id":"https://openalex.org/study-designs/randomized-controlled-trial"},{"display_name":"Clinical Trial","id":"https://openalex.org/study-designs/clinical-trial"}],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4409366371.pdf","grobid_xml":"https://content.openalex.org/works/W4409366371.grobid-xml"},"referenced_works_count":13,"referenced_works":["https://openalex.org/W2024931777","https://openalex.org/W2026115212","https://openalex.org/W2037015024","https://openalex.org/W2069716328","https://openalex.org/W2118316408","https://openalex.org/W2260920691","https://openalex.org/W2565321210","https://openalex.org/W2903254085","https://openalex.org/W2916610774","https://openalex.org/W2937292441","https://openalex.org/W2969469188","https://openalex.org/W2980595867","https://openalex.org/W6804975049"],"related_works":["https://openalex.org/W6892595220","https://openalex.org/W4407339192","https://openalex.org/W2767000774","https://openalex.org/W2287959710","https://openalex.org/W4411009607","https://openalex.org/W4368356302","https://openalex.org/W2378074446","https://openalex.org/W4395453604","https://openalex.org/W4391496339","https://openalex.org/W2015202902"],"abstract_inverted_index":{"Background":[0],"and":[1,28,39,73,90,100,125,136,158,221,247,270],"aim:":[2],"There":[3],"was":[4,22,109,225],"a":[5,146,248],"lack":[6],"of":[7,30,35,96,105,128,194,206,217,245,279],"sufficient":[8],"comparative":[9],"studies":[10],"on":[11,282],"ebastine,":[12],"either":[13],"alone":[14],"or":[15],"in":[16,53,149,152,181,198,228,256,264,272,293],"combination":[17,33,183,254,295],"with":[18,43,71,210,286],"montelukast.So,":[19],"this":[20],"study":[21,64,238],"performed":[23],"to":[24,168,233],"compare":[25],"the":[26,31,54,94,106,182,203,253,257,276,280,289,294,298],"efficacy":[27,104],"safety":[29,250],"fixed-dose":[32],"(FDC)":[34],"ebastine":[36,44,86,97,218,234],"10":[37,41,45,87,98,102,161,165,172,219,223,235],"mg":[38,42,46,88,99,162,173,220,224,236],"montelukast":[40,101,164,222],"monotherapy":[47,89],"for":[48,155,252,267],"managing":[49],"allergic":[50],"rhinitis":[51],"(AR)":[52],"Indian":[55,258],"population.Methodology:":[56],"A":[57,84,170],"randomized,":[58],"double-blind,":[59],"multicenter,":[60],"active-controlled,":[61],"Phase":[62],"3":[63],"included":[65],"individuals":[66],"aged":[67],"12-65":[68],"years":[69],"diagnosed":[70],"mild":[72],"intermediate-severe":[74],"persistent":[75],"AR.The":[76],"subjects":[77],"were":[78,139],"randomized":[79],"into":[80],"two":[81],"groups:":[82],"group":[83,91,153,169,184,296],"receiving":[85,93],"B":[92,154],"FDC":[95,216],"mg.The":[103],"treatment":[107],"regimens":[108],"assessed":[110],"through":[111],"Total":[112],"Symptom":[113,117],"Scores":[114,118],"(TSS),":[115],"Investigator":[116],"(ISS),":[119],"Visual":[120],"Analog":[121],"Scale":[122],"(VAS)":[123],"scores,":[124],"Rhinoconjunctivitis":[126],"Quality":[127],"Life":[129],"Survey":[130],"(RQLS).Safety":[131],"parameters,":[132],"including":[133],"biochemical":[134],"assessments":[135],"adverse":[137,212],"events,":[138],"also":[140],"systematically":[141],"analyzed.":[142],"Results:The":[143],"results":[144],"indicated":[145],"significant":[147,262],"reduction":[148,263],"TSS":[150],"scores":[151,176,266],"nasal":[156,268],"congestion":[157,269],"sneezing":[159,271],"(ebastine":[160,171],"+":[163],"mg)":[166],"compared":[167,232],"alone).The":[174],"VAS":[175,291],"demonstrated":[177,239],"enhanced":[178,240,299],"drug":[179,208,241,300],"effectiveness":[180],"at":[185],"week":[186],"2.":[187],"Both":[188],"groups":[189,274],"exhibited":[190],"an":[191],"improved":[192,243],"quality":[193,244],"life,":[195,246],"as":[196],"reflected":[197],"RQLS":[199],"scores.Safety":[200],"analyses":[201],"confirmed":[202],"well-tolerated":[204,249],"nature":[205],"both":[207,273],"regimens,":[209],"minimal":[211],"events":[213],"noted.Conclusion:":[214],"The":[215,261],"more":[226],"effective":[227],"reducing":[229],"AR":[230],"symptoms":[231,284],"alone.The":[237],"effectiveness,":[242],"profile":[251],"therapy":[255],"population.Clinical":[259],"significance:":[260],"ISS":[265],"highlights":[275],"positive":[277],"impact":[278],"treatments":[281],"specific":[283],"associated":[285],"AR.In":[287],"addition,":[288],"higher":[290],"score":[292],"underscores":[297],"effectiveness.":[301]},"counts_by_year":[],"updated_date":"2026-11-08T12:12:28.789561","created_date":"2025-04-12T00:00:00"}