Efficacy and safety of a drug-free, barrier-forming nasal spray for allergic rhinitis: randomized, open-label, crossover noninferiority trial

Background Symptoms of allergic rhinitis can be reduced by nonpharmacological nasal sprays that create a barrier between allergens and the nasal mucosa. A new nasal spray (AM-301) containing the clay mineral bentonite was tested for its ability to reduce symptoms to grass pollen. Methods This open label, crossover, noninferiority trial compared the efficacy and safety of AM-301 to that of hydroxypropyl methylcellulose (HPMC; Nasaleze Allergy Blocker), an established barrier method. Adults with seasonal allergic rhinitis were exposed to Dactylis glomerata pollen, in the Fraunhofer Allergen Challenge Chamber, first without protection and then protected by HPMC or AM-301 (7 days apart). Efficacy was assessed from total nasal symptom score (TNSS), nasal secretion weight, and subjective rating. The primary endpoint was the difference, between AM-301 and HPMC, in least square mean change in TNSS over a 4-hour exposure to allergen. Results The study enrolled 36 persons, and 35 completed all study visits. The mean TNSS was 5.91 during unprotected exposure, 5.20 during protection with HPMC, and 4.82 during protection with AM-301. The difference in least square means between the two treatments was -0.39 (95% CI, -0.89 to 0.10), establishing the noninferiority of AM-301. No difference in mean weight of nasal secretions was observed between the treatments. Efficacy was rated as good or very good for AM-301 by 31% and for HPMC by 14% of subjects. 16 subjects reported adverse events with a relationship to AM-301 or HPMC; most adverse events were mild and none was serious. Conclusions AM-301 demonstrated noninferiority towards HPMC in the primary endpoint and was perceived better in subjective secondary endpoints. Both barrier-forming products had a persisting protective effect over 4 hours and were safe. Trial registration German Clinical Trial Register (DRKS00024356). EUDAMED (CIV-20-10-034870). Key words: Allergen challenge, Allergy, Bentonite, Dactylis glomerata, Hydroxypropyl methylcellulose, Medical device, Nasal spray, Pollen, Rhinorrhea, Thixotropy

Download Full-text

Noninterventional Open-Label Trial Investigating the Efficacy and Safety of Ectoine Containing Nasal Spray in Comparison with Beclomethasone Nasal Spray in Patients with Allergic Rhinitis

Journal of Allergy ◽

10.1155/2014/297203 ◽

2014 ◽

Vol 2014 ◽

pp. 1-12 ◽

Cited By ~ 6

Author(s):

Uwe Sonnemann ◽

Marcus Möller ◽

Andreas Bilstein

Keyword(s):

Quality Of Life ◽

Allergic Rhinitis ◽

Nasal Spray ◽

Efficacy And Safety ◽

Open Label ◽

Equivalence Test ◽

Nasal Symptoms ◽

Open Label Trial ◽

Design And Methods

Objectives. The current study aimed to compare the efficacy and safety of a classical anti-inflammatory beclomethasone nasal spray in comparison to a physic-chemical stabilizing ectoine containing nasal spray in the treatment of allergic rhinitis. Design and Methods. This was a noninterventional, open-label, observational trial investigating the effects of beclomethasone or ectoine nasal spray on nasal symptoms and quality of life. Over a period of 14 days, patients were asked to daily document their symptoms. Efficacy and tolerability were assessed by both physicians and patients. Results. Both treatments resulted in a significant decrease of TNSS values. An equivalence test could not confirm the noninferiority of ectoine treatment in comparison with beclomethasone treatment. Although clear symptom reduction was achieved with the ectoine products, the efficacy judgment showed possible advantages for the beclomethasone group. Importantly, tolerability results were comparably good in both groups, and a very low number of adverse events supported this observation. Both treatments resulted in a clear improvement in the quality of life as assessed by a questionnaire answered at the beginning and at the end of the trial. Conclusion. Taken together, it was shown that allergic rhinitis can be safely and successfully treated with beclomethasone and also efficacy and safety were shown for ectoine nasal spray.

Download Full-text

TO EVALUATE EFFICACY AND SAFETY OF RUPATADINE, BILASTINE, AND LEVOCETRIZINE IN ALLERGIC RHINITIS AT TERITARY CARE HOSPITAL, TELANGANA

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2021.v14i12.43427 ◽

2021 ◽

pp. 140-143

Author(s):

NAGUR SHARONE GRACE ◽

SYED ARSHADDUDDIN AHMED ◽

BHUVANESWARI E ◽

SYED HAMZA QUADRI ◽

VEENA B ◽

...

Keyword(s):

Allergic Rhinitis ◽

Adverse Events ◽

Nasal Congestion ◽

Care Hospital ◽

Efficacy And Safety ◽

Open Label ◽

Once Daily ◽

Significant Difference ◽

The Mean ◽

The Government

Objective: Allergic rhinitis (AR) is a heterogeneous disorder characterized by symptoms – sneezing, itching, nasal congestion, and rhinorrhea. The aim of the study is to evaluate the efficacy and safety of rupatadine, bilastine, and levocetirizine in AR. Methods: A prospective, open-label, comparative study was conducted at the Government ENT Hospital, Hyderabad, Telangana. Ninety patients diagnosed with AR were randomized, of whom Group 1 received oral tab. bilastine 20 mg once daily, Group 2 received oral tab. levocetirizine 5 mg once daily, and Group 3 received oral tab. rupatadine with a dose of 10 mg once daily for 2 weeks. The reduction in total nasal symptom score (TNSS) and absolute eosinophil counts (AECs) was compared with baseline and at 2 weeks. Safety was assessed according to adverse events reported during the study period. An analysis of variance was used as a test of significance for the three groups. Results: Overall, 90 cases were included in the study, with 48% of males and 52% of females. All three drugs significantly reduced the TNSS and AEC after treatment compared to before treatment (p<0.05). The mean difference in TNSS and AEC showed no statistically significant difference among the three groups (TNSS: p>0.908 and AEC: p>0.967). In terms of safety, all three drugs showed nearly similar adverse events. Conclusion: In this study, after 2 weeks of follow-up, the three drugs (bilastine, levocetirizine, and rupatadine) showed significant improvement clinically, but the mean reduction in the score of symptoms and AEC was not statistically significant in the treatment of AR.

Download Full-text

Efficacy and safety of triamcinolone acetonide aqueous nasal spray in children aged 2 to 5 years with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled study with an open-label extension

Annals of Allergy Asthma & Immunology ◽

10.1016/s1081-1206(10)60340-7 ◽

2009 ◽

Vol 102 (4) ◽

pp. 339-347 ◽

Cited By ~ 9

Author(s):

Steven Weinstein ◽

Paul Qaqundah ◽

George Georges ◽

Anjuli Nayak

Keyword(s):

Allergic Rhinitis ◽

Triamcinolone Acetonide ◽

Nasal Spray ◽

Controlled Study ◽

Efficacy And Safety ◽

Perennial Allergic Rhinitis ◽

Open Label ◽

Double Blind ◽

Double Blind Placebo ◽

Open Label Extension

Download Full-text

A comparative study to assess the efficacy of fluticasone and mometasone in allergic rhinitis

International Journal of Otorhinolaryngology and Head and Neck Surgery ◽

10.18203/issn.2454-5929.ijohns20203503 ◽

2020 ◽

Vol 6 (9) ◽

pp. 1587

Author(s):

Waqar Ul Hamid ◽

Deepshikha Sumbria ◽

Ihsan Ali ◽

Rauf Ahmad

Keyword(s):

Allergic Rhinitis ◽

Comparative Study ◽

Nasal Spray ◽

Allergic Diseases ◽

Therapeutic Benefit ◽

Nasal Symptom ◽

Open Label ◽

Nasal Sprays ◽

Parallel Group ◽

The Difference

Background: Allergic rhinitis is the most prevalent of allergic diseases in the world. Pharmacotherapy remains the mainstay of treatment. Nasal corticosteroids being the most applicable drugs for its treatment. The objective of this study was to compare the efficacy of fluticasone propionate (FP) and mometasone furoate (MF) nasal sprays in the treatment of allergic rhinitis based on total nasal symptom score (TNSS) questionnaire.Methods: A prospective, randomized, open-label, parallel-group, comparative study was conducted among 80 allergic rhinitis patients fulfilling the inclusion and exclusion criteria. They were randomly assigned to two groups: FP and MF groups. FP group received 200 µg dose of FP nasal spray (1 spray/nostril) daily and the MF group received 100 µg dose of MF nasal spray (1 spray/nostril) daily for 8 weeks. The effects of the two agents were compared based on TNSS questionnaire in 0, 4 and 8 weeks after the beginning of the treatment. Results: At the end of eight weeks of treatment, both groups showed statistically significant (p<0.005) improvements from their baseline TNSS. Mean TNSS was reduced from to 9.46 to 2.716 in FP group and from 10.18 to 2.504 in MF group.Conclusions: Both the groups showed a significant therapeutic benefit in patients with allergic rhinitis. Even though, the difference between the two is not significant for 8 weeks therapy.

Download Full-text

Comparison of efficacy and tolerability of oral desloratadine, rupatadine and ketotifen in seasonal allergic rhinitis

IP Journal of Otorhinolaryngology and Allied Science ◽

10.18231/j.ijoas.2021.021 ◽

2021 ◽

Vol 4 (3) ◽

pp. 106-114

Author(s):

Syed Khadeer ◽

B Jagannath

Keyword(s):

Allergic Rhinitis ◽

Adverse Events ◽

Nasal Congestion ◽

Primary Outcome Measure ◽

Nasal Symptom ◽

Secondary Outcome ◽

Open Label ◽

Non Allergic Rhinitis ◽

The Individual ◽

Change In Mean

Rhinitis is inflammation of nasal mucosa which characteristically presents as running nose, blocked nose, itching on nose or sneezing. Allergic rhinitis is more common than non-allergic rhinitis. Anti-histamines are the mainstay of SAR treatment. Desloratadine, rupatadine and ketotifen are the commonly prescribed anti histamines in our region. In this study, we have compared efficacy and tolerability of desloratadine, rupatadine and ketotifen in SAR. This was a prospective, randomized, three arm, open label comparative study of desloratadine, rupatadine and ketotifen in SAR, conducted at Department of ENT, Kempegowda Institute of Medical Sciences, Bangalore; between January 2014 and December 2014. Patients’ severity of SAR symptoms were assessed by TNSS, QoL was measured using Medical Outcomes Study questionnaire (SF-12). SF-12 was administered at the start of study and then at the end of study. Adverse effects were monitored during clinical examination at each visit. Study subjects were systemically randomized into three groups – desloratadine (DES), rupatadine (RUP) and ketotifen (KET). Based on the assigned group; desloratadine was given orally in dose of 10mg OD, rupatadine orally 10 mg OD and ketotifen orally 1mg BD. All medications were given for 4 weeks. Follow up was done for all patients every week during treatment period of 4 weeks. The primary outcome measure was change in mean TNSS from baseline; secondary outcome measures were changes in the individual nasal symptom scores, change in the quality of life and tolerability to the study medications. Total 150 patients were recruited for this study, divided into 3 groups. DES and RUP were equally effective but significantly better than KET in improving rhinorrhea, nasal congestion, TNSS and AEC. (p=0.05). All the drugs were equally effective with no statistically significant intergroup difference in improving sneezing, nasal itching and QoL. RUP appeared to have better tolerability as the total number of adverse events were marginally less. DES and RUP are comparatively more effective and faster acting than KET. All the study medications were well tolerated with few mild, self-limiting, transient adverse events requiring no intervention.

Download Full-text

Efficacy and Safety of Olopatadine/Mometasone Combination Nasal Spray in Patients With Seasonal Allergic Rhinitis

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2017.12.550 ◽

2018 ◽

Vol 141 (2) ◽

pp. AB173 ◽

Cited By ~ 1

Author(s):

Frank C. Hampel ◽

Andrew J. Pedinoff ◽

Robert L. Jacobs ◽

Aurora Breazna ◽

Cynthia F. Caracta ◽

...

Keyword(s):

Allergic Rhinitis ◽

Nasal Spray ◽

Seasonal Allergic Rhinitis ◽

Efficacy And Safety

Download Full-text

EFFICACY AND SAFETY OF NASAL SPRAY PREVALIN IN THE TREATMENT OF ALLERGIC RHINITIS PATIENTS

Rossiiskii Allergologicheskii ZHurnal ◽

10.36691/rja710 ◽

2012 ◽

Vol 9 (5) ◽

pp. 55-59

Author(s):

A A Tsyvkina ◽

L V Luss ◽

S V Tsarev ◽

N V Shartanova

Keyword(s):

Allergic Rhinitis ◽

Nasal Cavity ◽

Nasal Spray ◽

Clinical Effect ◽

Clinical Symptoms ◽

Efficacy And Safety ◽

Nasal Breathing ◽

Results Of Treatment ◽

Functional Methods ◽

Positive Clinical Effect

Background. To study of efficacy, tolerability and safety of nasal spray Prevalin in the treatment of allergic rhinitis patients. Methods. 30 patients with allergic rhinitis in the age of18 till 45 years were observed. Prevalin was given as one insufflation into each nasal cavity 3 times a day for 21 days. Results of treatment were assessed by the dynamics of clinical symptoms and the results of functional methods . Results. The positive clinical effect was observed in 22 patients (73,3%), using Prevalin. Clinical effect was characterized by the restoration of nasal breathing, reduce swelling of the nasal mucosa. We did not establish a good result of treatment in 8 patients. Conclusion. The study demonstrated clinical efficacy and safety of spray Prevalin.

Download Full-text