PMID- 37140964
OWN - NLM
STAT- Publisher
LR  - 20231014
IS  - 1532-4303 (Electronic)
IS  - 0277-0903 (Linking)
VI  - 60
IP  - 11
DP  - 2023 Nov
TI  - Efficacy and safety of fixed-dose combination of Bilastine-Montelukast in adult 
      patients with allergic rhinitis: a phase III, randomized, multi-center, 
      double-blind, active controlled clinical study.
PG  - 2014-2020
LID - 10.1080/02770903.2023.2209175 [doi]
AB  - BACKGROUND: Histamine and cysteinyl leukotrienes (CysLTs) are potent inflammatory 
      mediators in allergic rhinitis (AR). Studies involving other combinations of 
      antihistaminics (Levocetirizine) and highly selective leukotriene receptor 
      antagonist (LTA) (Montelukast) combination have shown additive benefits and are 
      widely prescribed for AR. OBJECTIVE: Evaluate the efficacy and safety of 
      Bilastine 20 mg and Montelukast 10 mg fixed-dose combination (FDC) therapy in 
      patients with AR. METHODS: A randomized, double-blind, comparative, parallel, 
      phase III study was conducted to evaluate efficacy and safety of Bilastine 20 mg 
      and Montelukast 10 mg FDC at 16 tertiary care otolaryngology centres in India. 
      Adult patients with AR for one year with IgE antibody positive and 12-h NSS score 
      >36 in 3 days were randomized to receive either Bilastine 20 mg and Montelukast 
      10 mg or Montelukast 10 mg & Levocetirizine 5 mg tablets for 4 weeks. The change 
      in total symptom score (nasal symptom scores (NSS) & non-nasal symptom scores 
      (NNSS)) from baseline to week 4 was assessed as primary endpoint. Secondary 
      endpoints included changes in TSS, NSS, NNSS, individual symptom scores (ISS), 
      Rhinoconjunctivitis Quality of Life (RQLQ), discomfort due to rhinitis (VAS), and 
      clinical global impression (CGI) scores. RESULTS: The change in mean TSS from 
      baseline to week 4 in Test group (16.6 units) was comparable to reference group 
      (17 units) (p= 0.8876). The difference in change in mean NSS, NNSS and ISS from 
      baseline to day 7, 14, 28 were comparable. RQLQ improved from baseline to Day 28. 
      Significant improvements were observed in discomfort due to AR measured by VAS 
      and CGI scores from baseline to day 14 and 28. The safety and tolerability of 
      patients were comparable between the groups. All adverse events (AEs) were mild 
      to moderate in severity. No patient discontinued due to AEs. CONCLUSIONS: The FDC 
      of Bilastine 20 mg and Montelukast 10 mg was efficacious and well tolerated in 
      Indian patients with AR.
FAU - Sinha, Shubhadeep D
AU  - Sinha SD
AUID- ORCID: 0000-0002-1797-3250
AD  - Department of Clinical Development & Medical Affairs, Hetero, Hyderabad, 
      Telengana, India.
FAU - Perapogu, Sridevi
AU  - Perapogu S
AD  - Department of ENT, Government Medical College & Hospital, SPSR, Nellore, Andhra 
      Pradesh, India.
FAU - Chary S, Sreenivasa
AU  - Chary S S
AUID- ORCID: 0009-0004-7415-7729
AD  - Department of Clinical Development & Medical Affairs, Hetero, Hyderabad, 
      Telengana, India.
FAU - Ramesh, S
AU  - Ramesh S
AD  - Department of ENT, Govt Medical College & Govt General Hospital, Srikakulam, 
      Andhra Pradesh, India.
FAU - Bakshi, Jaimanti
AU  - Bakshi J
AD  - Department of ENT, Postgraduate Institute of Medical Education and Research, 
      Chandigarh, India.
FAU - Singh, Ajit
AU  - Singh A
AD  - Division of Allergy & Pulmonary Medicine, Dhanvantri OPD Block, SMS Hospital, 
      Jaipur, Rajasthan, India.
FAU - Ahmed, Abdul Khabeer
AU  - Ahmed AK
AD  - Department of ENT, Gandhi Hospital, Secunderabad, Telangana, India.
FAU - Mohan Reddy, B
AU  - Mohan Reddy B
AD  - Department of Clinical Development & Medical Affairs, Hetero, Hyderabad, 
      Telengana, India.
FAU - Panapakam, Muralidhar
AU  - Panapakam M
AD  - Department of Clinical Development & Medical Affairs, Hetero, Hyderabad, 
      Telengana, India.
FAU - Talluri, Leela
AU  - Talluri L
AUID- ORCID: 0000-0001-8503-7897
AD  - Department of Clinical Development & Medical Affairs, Hetero, Hyderabad, 
      Telengana, India.
FAU - Vattipalli, Ramya
AU  - Vattipalli R
AD  - Department of Clinical Development & Medical Affairs, Hetero, Hyderabad, 
      Telengana, India.
LA  - eng
PT  - Journal Article
DEP - 20230531
PL  - England
TA  - J Asthma
JT  - The Journal of asthma : official journal of the Association for the Care of 
      Asthma
JID - 8106454
SB  - IM
OTO - NOTNLM
OT  - Second-generation antihistamine
OT  - allergic rhinitis
OT  - clinical trial
OT  - fixed-dose combination
OT  - leukotriene receptor antagonist
OT  - safety
OT  - total symptom score
EDAT- 2023/05/04 12:42
MHDA- 2023/05/04 12:42
CRDT- 2023/05/04 11:53
PHST- 2023/05/04 12:42 [pubmed]
PHST- 2023/05/04 12:42 [medline]
PHST- 2023/05/04 11:53 [entrez]
AID - 10.1080/02770903.2023.2209175 [doi]
PST - ppublish
SO  - J Asthma. 2023 Nov;60(11):2014-2020. doi: 10.1080/02770903.2023.2209175. Epub 
      2023 May 31.