A placebo- and active-controlled randomized trial of prophylactic treatment of seasonal allergic rhinitis with mometasone furoate aqueous nasal spray

Graft, David F.; Aaronson, Donald W.; Chervinsky, Paul; Kaiser, Harold B.; Melamed, Julian; Pedinoff, Andrew; Rosen, James P.; Schenkel, Eric; Vandewalker, M L; KEIM, A

doi:10.1016/s0091-6749(96)70119-7

Cited by 107 publications

(68 citation statements)

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“…One study included both postintervention and postnasal challenge measurements (17). Consequently, 17 evaluations on TNSS were included (10 interventional studies comparing MFNS vs placebo for the treatment of AR in 1878 adults (17-19, 21, 49-54); one RCT evaluating 271 children (24); five studies assessing postchallenge effects on TNSS in 634 participants (17,(55)(56)(57)(58) and one study commenced treatment 4 weeks preseasonally (n = 215) (20). Data on the individual nasal symptom scores were available in seven studies including 1582 subjects (19,21,(49)(50)(51)(52)54).…”

Section: Search Resultsmentioning

confidence: 99%

“…Nonnasal symptom scores were assessed in four studies (n = 1009) (21, 49, 51, 52) and nasal airflow in three studies (n = 271) (17,50,53). The frequency of adverse events (AE) was available in nine trials (n = 2072) (17,18,20,21,24,49,51,52,54 (18,20,21,24,50,51) and one vs azelastine (57). All authors gave MFNS once a day (Table 1).…”

Section: Search Resultsmentioning

confidence: 99%

“…In the study carried out in children (135 received MFNS 100 lg/and 136 placebo), those treated with MFNS showed a significant reduction in nasal symptoms (SMD )0.41, 95% CI: )0.65 to )0.17; P = 0.0008) (24). In the RCT conducted by Graft et al (20), subjects were preseasonally treated during 4 weeks and then for 4 weeks more (114 MFNS and 101 placebo). Those receiving MFNS showed lower TNSS (SMD )0.35, 95% CI: )0.62 to )0.08; P = 0.01) (20) (Fig.…”

Section: Discussionmentioning

confidence: 99%

“…Data were available in the full text version of five papers (19,24,50,55,57); authors or associate investigators of six studies provided SD and/or means (21,49,(51)(52)(53)(54); in five studies, means were available, but SD were obtained from both mean differences and P-values following the Cochrane Collaboration guidelines (17,18,20,56,58).…”

Section: Data Extractionmentioning

confidence: 99%

“…preventing the onset of symptoms in such patients (20). Furthermore, MFNS has proven efficacy for the sustained treatment of perennial AR (PAR; 4, 21).…”

mentioning

confidence: 99%

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Efficacy of mometasone furoate nasal spray in the treatment of allergic rhinitis. Meta‐analysis of randomized, double‐blind, placebo‐controlled, clinical trials

Penagos

Compalati

Tarantini

et al. 2008

Allergy

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Rationale: Several randomized, double‐blind, placebo‐controlled clinical trials have demonstrated the efficacy of mometasone furoate nasal spray (MFNS) in the treatment of allergic rhinitis (AR) thus allowing for a meta‐analysis to determine the overall treatment effect.Methods: A comprehensive search of the MEDLINE, LILACS, SCOPUS, and the Cochrane Library databases up to 31 October, 2007 was carried out. Randomized, double‐blind, placebo‐controlled, clinical trials evaluating the efficacy of MFNS in patients with AR compared to placebo were included. Total nasal symptom scores (TNSS), individual nasal symptoms, total non‐nasal symptom scores (TNNSS) and nasal airflow were analysed as the standardized mean difference (SMD). Meta‐analysis was performed with the random or the fixed effect models depending on heterogeneity, by using revman 5 software.Data synthesis: Sixteen of the 113 identified articles met the inclusion criteria. For MFNS efficacy on TNSS, 2998 participants were analysed: 1534 received MFNS and 1464 placebo. Mometasone furoate nasal spray was associated with a significant reduction in TNSS (SMD −0.49, 95% CI: −0.60 to −0.38; P < 0.00001; I2 = 50.1%). A significant effect on SMD for nasal stuffiness/congestion (−0.41; 95% CI: −0.56 to −0.27), rhinorrhoea (−0.44; 95% CI: −0.66 to −0.21), sneezing (−0.40; 95% CI: −0.57 to −0.23) and nasal itching (−0.39; 95% CI: −0.53 to −0.25) was also demonstrated. Mometasone furoate nasal spray treated subjects also showed a significant reduction in TNNSS (−0.30; 95% CI: −0.43 to −0.18). The proportion of patients with adverse events was similar for MFNS and placebo (0.99; 95% CI: 0.81–1.20; P = 0.91).Conclusions: This meta‐analysis provides a level Ia evidence for the efficacy of MFSN in the treatment of AR vs placebo. Adverse events frequency was similar in both groups.

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Section: Search Resultsmentioning

confidence: 99%

Section: Search Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Data Extractionmentioning

confidence: 99%

“…preventing the onset of symptoms in such patients (20). Furthermore, MFNS has proven efficacy for the sustained treatment of perennial AR (PAR; 4, 21).…”

mentioning

confidence: 99%

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