Nasal filters for the treatment of allergic rhinitis: A randomized, double-blind, placebo- controlled crossover clinical trial Peter Kenney, BA, BSc,

Slides:

Advertisements

Similar presentations

Nasal challenge with allergen leads to maxillary sinus inflammation

Advertisements

Clinical Application of Nasal Filters: An Observational Study on the Usability of Nasal Filters in Managing Seasonal Allergic Rhinitis Peter Kenney,

Safety risks for patients with aspirin-exacerbated respiratory disease after acute exposure to selective nonsteroidal anti-inflammatory drugs and COX-2.

Clinical trial design, nasal allergen challenge models, and considerations of relevance to pediatrics, nasal polyposis, and different classes of medication

Jonathan A. Bernstein, MD, David M. Lang, MD, David A. Khan, MD

Probiotics and prebiotic galacto-oligosaccharides in the prevention of allergic diseases: A randomized, double-blind, placebo-controlled trial Kaarina.

Trichuris suis ova therapy for allergic rhinitis: A randomized, double-blind, placebo- controlled clinical trial Peter Bager, PhD, John Arnved, MD, Steen.

Oxymetazoline adds to the effectiveness of fluticasone furoate in the treatment of perennial allergic rhinitis Fuad M. Baroody, MD, David Brown, MD,

Efficacy and tolerability of systemic methylprednisolone in children and adolescents with chronic rhinosinusitis: A double-blind, placebo-controlled randomized.

Oral Phenylephrine HCl for Nasal Congestion in Seasonal Allergic Rhinitis: A Randomized, Open-label, Placebo-controlled Study Eli O. Meltzer, MD, Paul.

Kyoung-Bok Min, MD, PhD, Jin-Young Min, PhD

Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5– grass pollen tablet for seasonal allergic rhinitis Alain Didier, MD,

Santa Jeremy Ono, BA, PhD, Mark B. Abelson, MD

Fluticasone furoate nasal spray: A single treatment option for the symptoms of seasonal allergic rhinitis Harold B. Kaiser, MD, Robert M. Naclerio, MD,

Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults Peter S. Creticos, MD, Jennifer Maloney,

Safety risks for patients with aspirin-exacerbated respiratory disease after acute exposure to selective nonsteroidal anti-inflammatory drugs and COX-2.

Randomized phase 1 study of the phosphatidylinositol 3-kinase δ inhibitor idelalisib in patients with allergic rhinitis Friedrich Horak, MD, Kamal D.

Is 9 more than 2 also in allergic airway inflammation?

Clinical Application of Nasal Filters: An Observational Study on the Usability of Nasal Filters in Managing Seasonal Allergic Rhinitis Peter Kenney,

Preventive effect of nasal filters on allergic rhinitis: A randomized, double-blind, placebo- controlled crossover park study Peter Kenney, BSc, Ole Hilberg,

Bruce M. Prenner, MD, Bobby Q. Lanier, MD, David I

Jonathan A. Bernstein, MD, David M. Lang, MD, David A. Khan, MD

Children with allergic and nonallergic rhinitis have a similar risk of asthma Bo Lund Krogsgaard Chawes, MD, Klaus Bønnelykke, MD, PhD, Eskil Kreiner-Møller,

Lieuwe D. Bos, MSc, PhD, Peter J. Sterk, MD, PhD, Stephen J

Nasal filters for the treatment of allergic rhinitis: A randomized, double-blind, placebo- controlled crossover clinical trial Peter Kenney, BA, BSc,

Tiotropium is noninferior to salmeterol in maintaining improved lung function in B16- Arg/Arg patients with asthma Eric D. Bateman, MD, Oliver Kornmann,

Oxymetazoline adds to the effectiveness of fluticasone furoate in the treatment of perennial allergic rhinitis Fuad M. Baroody, MD, David Brown, MD,

The risk of asthma exacerbation after stopping low-dose inhaled corticosteroids: A systematic review and meta-analysis of randomized controlled trials

Reply Journal of Allergy and Clinical Immunology

A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine–refractory chronic idiopathic urticaria

Tari Haahtela, MD, PhD, Klaus Tamminen, MD, Tuomo Kava, MD, PhD, L

Peter M. Wolfgram, MD, David B. Allen, MD

William J. Calhoun, MD, Tmirah Haselkorn, PhD, Dave P

Effect of intranasal azelastine and beclomethasone dipropionate on nasal symptoms, nasal cytology, and bronchial responsiveness to methacholine in allergic.

Reply Journal of Allergy and Clinical Immunology

Daily home measurements of exhaled nitric oxide in asthmatic children during natural birch pollen exposure Signe Vahlkvist, MD, Marianne Sinding, Kirsten.

Debra J. Palmer, PhD, Thomas R. Sullivan, BMa&CompSc(Hons), Michael S

Time for a paradigm shift in asthma treatment: From relieving bronchospasm to controlling systemic inflammation Leif Bjermer, MD Journal of Allergy.

Trichuris suis ova therapy for allergic rhinitis: A randomized, double-blind, placebo- controlled clinical trial Peter Bager, PhD, John Arnved, MD, Steen.

Biosimilars and drug development in allergic and immunologic diseases

Allergen-specific immunotherapy with recombinant grass pollen allergens Marek Jutel, MD, Lothar Jaeger, MD, Roland Suck, PhD, Hanns Meyer, Dipl Math,

A cluster-randomized trial shows telephone peer coaching for parents reduces children's asthma morbidity Jane M. Garbutt, MB, ChB, Yan Yan, MD, PhD,

Claus Bachert, MD, PhD, Cezmi A. Akdis, MD

What is an “eosinophilic phenotype” of asthma?

Sublingual immunotherapy with once-daily grass allergen tablets: A randomized controlled trial in seasonal allergic rhinoconjunctivitis Stephen R. Durham,

Autophagy: Nobel Prize 2016 and allergy and asthma research

Food allergy: Epidemiology, pathogenesis, diagnosis, and treatment

Nasal AMP and histamine challenge within and outside the pollen season in patients with seasonal allergic rhinitis Sriram Vaidyanathan, MBBS, Peter Williamson,

Biology of nasal polyposis

Martin Brasholt, MD, Florent Baty, PhD, Hans Bisgaard, MD, DMSci

Nasal inflammatory mediators and specific IgE production after nasal challenge with grass pollen in local allergic rhinitis Carmen Rondón, MD, PhD, Javier.

Change in visual analog scale score in a pragmatic randomized cluster trial of allergic rhinitis Philippe-Jean Bousquet, MD, Christophe Combescure, PhD,

Objective monitoring of nasal patency and nasal physiology in rhinitis

A randomized trial of methotrexate versus azathioprine for severe atopic eczema Mandy Elvira Schram, MD, Evelien Roekevisch, MD, Mariska Maria Geertruida.

Alvaro A. Cruz, MD, Robert M

Short course of systemic corticosteroids in sinonasal polyposis: A double-blind, randomized, placebo-controlled trial with evaluation of outcome measures

Nasal challenge with allergen leads to maxillary sinus inflammation

Problem solving to improve adherence and asthma outcomes in urban adults with moderate or severe asthma: A randomized controlled trial Andrea J. Apter,

Macrolide antibiotics and asthma treatment

Bo L. K. Chawes, MD, Matthew J

Statistical issues in clinical trials that involve the double-blind, placebo-controlled food challenge Vernon M. Chinchilli, PhD, Laura Fisher, MD, Timothy.

Tiotropium is noninferior to salmeterol in maintaining improved lung function in B16- Arg/Arg patients with asthma Eric D. Bateman, MD, Oliver Kornmann,

Daniel Menzies, MBChB, Arun Nair, MBBS, Karen T

Probiotic supplementation for the first 6 months of life fails to reduce the risk of atopic dermatitis and increases the risk of allergen sensitization.

The effects of an H3 receptor antagonist (PF ) with fexofenadine on reducing allergic rhinitis symptoms Jeffrey R. Stokes, MD, Francisco A. Romero,

Double-blind, placebo-controlled study with a modified therapeutic vaccine of Salsola kali (Russian thistle) administered through use of a cluster schedule

Efficacy and tolerability of systemic methylprednisolone in children and adolescents with chronic rhinosinusitis: A double-blind, placebo-controlled randomized.

Effect of codeine on objective measurement of cough in chronic obstructive pulmonary disease Jaclyn Smith, MD, PhD, Emily Owen, MPhil, John Earis, MD,

Natural history of cow’s milk allergy

Primary prevention of asthma and allergy

Presentation transcript:

Nasal filters for the treatment of allergic rhinitis: A randomized, double-blind, placebo- controlled crossover clinical trial Peter Kenney, BA, BSc, Ole Hilberg, MD, DMSci, Henrik Pedersen, PhD, Ole Bækgaard Nielsen, PhD, Torben Sigsgaard, MD, PhD Journal of Allergy and Clinical Immunology Volume 133, Issue 5, Pages 1477-1480.e13 (May 2014) DOI: 10.1016/j.jaci.2014.01.004 Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 A, The devices. Left, Placebo. Right, Rhinix nasal filter. B, Standardized method of insertion. Please note that the illustration depicts how a user would insert it. In the study an operator inserted and removed all devices using a similar standardized method. This was done to ensure blinding. Journal of Allergy and Clinical Immunology 2014 133, 1477-1480.e13DOI: (10.1016/j.jaci.2014.01.004) Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E2 Trial protocol. Safety check included blood pressure, pulse, temperature, and physical examination results. Recordings at baseline and 220 and 390 minutes included symptoms (TNSSs, TOSSs, and throat irritation), acoustic rhinometry, FEV1, and nitrogen oxide in exhaled air. During exposure, TNSSs and TOSSs were obtained every 30 minutes. The devices were evaluated on usability at 220 minutes. AE, Adverse event. Journal of Allergy and Clinical Immunology 2014 133, 1477-1480.e13DOI: (10.1016/j.jaci.2014.01.004) Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E3 Study flow diagram. #Three subjects were excluded from the analyses (see text for details). Journal of Allergy and Clinical Immunology 2014 133, 1477-1480.e13DOI: (10.1016/j.jaci.2014.01.004) Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E4 Pollen exposure levels in the EEU in grains per cubic meter with SEMs as error bars. Note that 15 minutes before each EEU session, pre-exposure recordings were performed. The exposure sessions ended at 210 minutes when participants left the EEU. Pollen levels were counted every 30 minutes. Journal of Allergy and Clinical Immunology 2014 133, 1477-1480.e13DOI: (10.1016/j.jaci.2014.01.004) Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E5 Mean TNSSs with SEMs as error bars. Note that exposure in the EEU was from time point 0 to 210 minutes. Symptoms at baseline and 220 and 390 minutes were recorded outside of exposure. Exposure levels are presented as means ± SDs. Journal of Allergy and Clinical Immunology 2014 133, 1477-1480.e13DOI: (10.1016/j.jaci.2014.01.004) Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E6 Device evaluation. A, Proportion of subjects aware of wearing a device. B, Time points for noticing breathing resistance in the 13 of 21 subjects who felt increased resistance. C, Intended period of use for the 19 of 21 subjects who wanted to use the device. D, Proportion of subjects who believed the device was completely safe to use. Journal of Allergy and Clinical Immunology 2014 133, 1477-1480.e13DOI: (10.1016/j.jaci.2014.01.004) Copyright © 2014 American Academy of Allergy, Asthma & Immunology Terms and Conditions