PMID- 24871808
OWN - NLM
STAT- MEDLINE
DCOM- 20150330
LR  - 20161020
IS  - 1539-6304 (Electronic)
IS  - 1088-5412 (Linking)
VI  - 35
IP  - 4
DP  - 2014 Jul-Aug
TI  - Comparative safety and efficacy of two formulations of mometasone nasal spray in 
      adult seasonal allergic rhinitis.
PG  - 332-7
LID - 10.2500/aap.2014.35.3770 [doi]
AB  - Mometasone furoate as a nasal spray is an effective treatment for seasonal 
      allergic rhinitis (SAR). An aqueous mometasone nasal spray containing the same 
      active substance and excipients as the originator product (reference mometasone) 
      has been developed. This study was designed to establish therapeutic equivalence 
      of test mometasone to reference mometasone and superiority over placebo for the 
      treatment of SAR in adults. In this multicenter, randomized, double-blind, 
      placebo- and active-controlled, fixed-dose study, patients aged >/=18 years with 
      SAR were randomized 2:2:1 to reference mometasone, test mometasone, or placebo 
      for 28 days. Patients recorded nasal and ocular symptoms daily. The primary end 
      point was change from baseline in the pooled 24-hour reflective total nasal 
      symptom score (rTNSS). Safety and tolerability included evaluation by adverse 
      events (AEs), physical (including nasal) examinations, vital signs assessments, 
      laboratory evaluations, and change in concomitant medications. Four hundred two 
      patients received reference mometasone (n = 156), test mometasone (n = 163), or 
      placebo (n = 83). The intent-to-treat population (ITT) comprised 399 patients, 
      and the per-protocol (PP) population comprised 327 patients. The 95% confidence 
      intervals for the treatment difference (reference minus test mometasone) in 
      change from baseline in pooled 24-hour rTNSS were within prespecified equivalence 
      limits for the PP and ITT populations. Both active treatments showed superiority 
      over placebo (p = 0.0019-0.0087). No significant difference was seen between test 
      mometasone and reference mometasone for any secondary efficacy variables. 
      Treatment-emergent AE incidence was low. No deaths or serious AEs were reported. 
      The test mometasone is efficacious in the treatment of SAR in adults and shows a 
      favorable safety profile. The results indicate that the test mometasone is 
      therapeutically equivalent to the reference mometasone.
FAU - Kuna, Piotr
AU  - Kuna P
AD  - Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, 
      Medical University of Lodz, Lodz Poland.
FAU - Wasiak, Wojciech
AU  - Wasiak W
FAU - Jones, Spencer
AU  - Jones S
FAU - Kreft, Katarina Zajc
AU  - Kreft KZ
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140527
PL  - United States
TA  - Allergy Asthma Proc
JT  - Allergy and asthma proceedings
JID - 9603640
RN  - 0 (Anti-Allergic Agents)
RN  - 0 (Nasal Sprays)
RN  - 0 (Pregnadienediols)
RN  - 04201GDN4R (Mometasone Furoate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anti-Allergic Agents/*administration & dosage/adverse effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mometasone Furoate
MH  - *Nasal Sprays
MH  - Pregnadienediols/*administration & dosage/adverse effects
MH  - Rhinitis, Allergic, Seasonal/*drug therapy
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2014/05/30 06:00
MHDA- 2015/03/31 06:00
CRDT- 2014/05/30 06:00
PHST- 2014/05/30 06:00 [entrez]
PHST- 2014/05/30 06:00 [pubmed]
PHST- 2015/03/31 06:00 [medline]
AID - content-37700 [pii]
AID - 10.2500/aap.2014.35.3770 [doi]
PST - ppublish
SO  - Allergy Asthma Proc. 2014 Jul-Aug;35(4):332-7. doi: 10.2500/aap.2014.35.3770. 
      Epub 2014 May 27.