Evidence map›Paper›PMID 38195833›Full record

Observational studyClinical drug investigation2024

A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate-Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis.

Meenesh R Juvekar, Gauri Kapre Vaidya, Aniruddha Majumder, Amod D Pendharkar, Anthony Irudhayarajan, Avijit Kundu, D Ramesh, J Dheeraj Kumar, B Jagannatha, Joseph Mathew and 12 more

Registry-linked trialAbstract readObservational StudyMulticenter Study
PubMed Publisher
In one paragraph

Observational study in Clinical drug investigation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06830109 (Nasal Obstruction Randomized Trial With Oxymetazoline and Corticosteroids), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.9field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06830109 phase2recruitingnot on this map

Nasal Obstruction Randomized Trial With Oxymetazoline and Corticosteroids

TypeinterventionalSponsorWashington University School of MedicineRan2024 to 2026Enrolled80ConditionsNasal ObstructionArmsOxymetazoline Nasal Spray, Budesonide nasal spray
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 9 institutions in 1 country.

Meenesh R JuvekarENT Department, Juvekar Nursing Home, Mumbai, Maharashtra, India.
Gauri Kapre VaidyaNeeti Clinics, Nagpur, Maharashtra, India.
Aniruddha MajumderSpeciality ENT Clinic, Kolkata, West Bengal, India.
Amod D PendharkarENT Department, Shri Ram Nursing Home, Satara, Maharashtra, India.
Anthony IrudhayarajanDr Anthony's ENT Centre, Chennai, Tamil Nadu, India.
Avijit KunduSuraksha, Barrackpore, West Bengal, India.
D RameshENT Department, Apollo Family Clinic, Chennai, Tamil Nadu, India.
J Dheeraj KumarENT Department, Virinchi Hospitals, Hyderabad, Telangana, India.
B JagannathaKIMS & RC, Bangalore, Karnataka, India.
Joseph MathewENT Department, Lisie Hospital, Cochin, Kerala, India.
Mahesh P NikamENT Department, Shreepad Hospital, Nashik, Maharashtra, India.
Madhuri MehtaENT Department, N C Jindal Institute of Medical Care & Research, Hisar, Haryana, India.
Neeraj ChawlaENT Department, Delhi Hospital, Delhi, India.
Priti HajareENT Department, KLE's Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi, Karnataka, India.
P G Chandre GowdaSankalpa ENT Care Centre, Bangalore, Karnataka, India.
P V L N MurthyENT Department, Star Hospitals, Hyderabad, Telangana, India.
Suma Moni MathewENT Department, Christian Mission Hospital, Madurai, Tamil Nadu, India.
Makarand V DamleMetro ENT Hospital, Mumbai, Maharashtra, India.
Chandra KantDr. Chandrakant Clinic, Ranchi, Jharkhand, India.
Arun B NairGitanjali Eye and ENT Hospital, Thiruvananthapuram, Kerala, India.
Ashok JaiswalMedical and Regulatory Affairs, Zydus Healthcare Limited, Walia Business Park, Goregaon, Mumbai, Maharashtra, 400063, India.
Ravi T MehtaMedical and Regulatory Affairs, Zydus Healthcare Limited, Walia Business Park, Goregaon, Mumbai, Maharashtra, 400063, India. RaviT.Mehta@zyduslife.com.ORCID http://orcid.org/0000-0001-6745-9391
Cadila Healthcare (India) · INApollo Hospitals · INApollo Hospitals · INChaithanya Eye Hospital and Research Institute · INHindu Mission Hospital · INJoshi Hospital · INKempegowda Institute of Medical Sciences · INKLE Society Hospital · INLourdes Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAllergic rhinitis (AR) has shown an increasing prevalence leading to a considerable medical and social burden. Nasal congestion is the cardinal symptom of AR, and the upper respiratory tract is most affected by this long-lasting ailment. Intranasal corticosteroids alleviate nasal congestion, along with other symptoms of AR, but their effect is not evident immediately. Oxymetazoline has a rapid onset of action, but its use should be limited to 3-5 days.

objectiveThe study aimed to evaluate the safety and effectiveness of the fixed-dose combination nasal spray containing fluticasone furoate and oxymetazoline hydrochloride (FF + OXY) 27.5/50 mcg once daily in patients with AR in a real-world clinical setting.

methodsThe study was a prospective, open-label, single-arm, multicenter, real-world observational study conducted in patients with AR for a period of 28 days. Patients (n = 388) with a diagnosis of AR were treated with a combination of FF + OXY nasal spray. Total nasal symptom score (TNSS), total ocular symptom score (TOSS) and total symptom score (TSS) were documented at baseline and at the end of study period. The overall effectiveness of treatment with FF + OXY was rated by the investigators as very good/good/satisfactory/poor (4-point Likert scale) for each patient.

resultsTreatment with FF + OXY resulted in significant reduction in the TNSS, TOSS and TSS, from 7.18 ± 3.38 at baseline to 0.20 ± 0.84 (p < 0.001), from 2.34 ± 2.29 at baseline to 0.09 ± 0.53 (p < 0.001), from 9.51 ± 4.94 at baseline to 0.29 ± 1.32 (p < 0.001) at 28 days respectively. With respect to effectiveness, the investigators reported very good effectiveness in 52.12% of patients. No serious adverse events were reported.

conclusionThe fixed-dose combination of once-daily fluticasone furoate and oxymetazoline hydrochloride nasal spray 27.5/50 mcg was effective in relieving the nasal congestion and reduction of TNSS, TOSS and TSS in patients suffering from AR. The combination was safe and well tolerated with no rebound congestion throughout the treatment period.

Indexed as

AndrostadienesAnti-Allergic AgentsRhinitis, AllergicRhinitis, Allergic, SeasonalAdministration, IntranasalDouble-Blind MethodHumansNasal SpraysOxymetazolineProspective StudiesTreatment OutcomeAndrostadienesAnti-Allergic Agentsfluticasone furoateNasal SpraysOxymetazoline

Identifiers

PMID38195833
OpenAlexW4390707060

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.