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Carson S, Lee N, Thakurta S. Drug Class Review: Newer Antihistamines: Final Report Update 2 [Internet]. Portland (OR): Oregon Health & Science University; 2010 May.
This publication is provided for historical reference only and the information may be out of date.
The following full-text publications were considered for inclusion but failed to meet the criteria for this report. See previous versions of the report on the DERP website for studies excluded previously.
2=outcome not included, 3=intervention not included, 4=population not included, 5=publication type not included, 6=study design not included, 7=study not obtainable.
| Exclusion Excluded studies | Exclusion code # |
|---|---|
| Head-to-head trials | |
| Day J, Briscoe M, Rafeiro E, et al. Comparative efficacy of cetirizine and fexofenadine for seasonal allergic rhinitis, 5–12 hours postdose, in the environmental exposure unit. Allergy Asthma Proc. 2005;26(4):275–282. | 6 |
| Day JH, Briscoe MP, Rafeiro E, Hewlett D, Chapman D, Kramer B. Randomized double-blind comparison of cetirizine and fexofenadine after pollen challenge in the Environmental Exposure Unit: duration of effect in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2004;25(1):59–68. | 6 |
| Kaiser HB, Gopalan G, Chung W. Loratadine provides early symptom control in seasonal allergic rhinitis. Allergy & Asthma Proceedings. 2008;29(6):654–658. | 6 |
| Meltzer EO, Garadi R, Laforce C, et al. Comparative study of sensory attributes of two antihistamine nasal sprays: olopatadine 0.6% and azelastine 0.1%. Allergy & Asthma Proceedings. 2008;29(6):659–668. | 2 |
| Pipkorn P, Costantini C, Reynolds C, et al. The effects of the nasal antihistamines olopatadine and azelastine in nasal allergen provocation. Ann Allerg Asthma Im. 2008;101(1):82–89. | 6 |
| Sanofi A. Single center, randomized, double-blind, crossover study comparing the effects of single-dose fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on cognitive performance in naval flight personnel [completed]. ClinicalTrials.gov [accessed. 2008;31. | 4 |
| Ucb. Five parallel groups, exploratory clinical trial to compare the efficacy of single dose levocetirizine 2.5 and 5 mg, cetirizine 5 mg and 10 mg to placebo in reducing symptoms of SAR in sensitive subjects exposed to ragweed pollen in a EEU [completed]. ClinicalTrials.gov. | 7 |
| Active- control trials | |
| Day JH, Briscoe M, Widlitz MD. Cetirizine, loratadine, or placebo in subjects with seasonal allergic rhinitis: effects after controlled ragweed pollen challenge in an environmental exposure unit. J Allergy Clin Immunol. 1998;101(5):638–645. | 6 |
| Day JH, Briscoe MP, Clark RH, Ellis AK, Gervais P. Onset of action and efficacy of terfenadine, astemizole, cetirizine, and loratadine for the relief of symptoms of allergic rhinitis. Ann Allerg Asthma Im. 1997;79(2):163–172. | 6 |
| Horak F, Zieglmayer PU, Zieglmayer R, Kavina A, Lemell P. Levocetirizine has a longer duration of action on improving total nasal symptoms score than fexofenadine after single administration. Br J Clin Pharmacol. 2005;60(1):24–31. | 6 |
| Meltzer EO, Weiler JM, Widlitz MD. Comparative outdoor study of the efficacy, onset and duration of action, and safety of cetirizine, loratadine, and placebo for seasonal allergic rhinitis. J Allergy Clin Immunol. 1996;97(2):617–626. | 6 |
| Passalacqua G, Guerra L, Compalati E, et al. Comparison of the effects in the nose and skin of a single dose of desloratadine and levocetirizine over 24 hours. Int Arch Allergy Immunol. 2004;135(2):143–147. | 6 |
| Weiler JM, Bloomfield JR, Woodworth GG, et al. Effects of fexofenadine, diphenhydramine, and alcohol on driving performance. A randomized, placebo-controlled trial in the Iowa driving simulator. Ann Intern Med. 2000;132(5):354–363. | 6 |
| Active and placebo controlled trial | |
| Sanofi A. Single-center, double-blind, randomized, parallel study comparing onset of action, efficacy & safety of a single-dose of fexofenadine HCl 180 mg vs montelukast Na 10 mg & placebo in treating seasonal allergic rhinitis subjects in an allergen exposure unit (study I) [completed]. ClinicalTrials.gov | 6 |
| Placebo controlled trials | |
| Banov CH, Lieberman P, Vasomotor Rhinitis Study G. Efficacy of azelastine nasal spray in the treatment of vasomotor (perennial nonallergic) rhinitis. Ann Allerg Asthma Im. 2001;86(1):28–35. | 4 |
| Chervinsky P, Philip G, Malice MP, et al. Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies. Ann Allerg Asthma Im. 2004;92(3):367–373. | 3 |
| Gehanno P, Deschamps E, Garay E, Baehre M, Garay RP. Vasomotor rhinitis: clinical efficacy of azelastine nasal spray in comparison with placebo. Orl; Journal of Oto-Rhino-Laryngology & its Related Specialties. 2001;63(2):76–81. | 5 |
| GlaxoSmithKline. A randomized, double blind, placebo controlled study for evaluation of the efficacy and safety of cetirizine dry syrup (CTZ DS) (2.5 mg or 5 mg twice a day) in children (2 years of age or older but under 15 years old) suffering from perennial allergic rhinitis. [completed]. ClinicalTrials.gov | 7 |
| Hyo S, Fujieda S, Kawada R, Kitazawa S, Takenaka H. The efficacy of short-term administration of 3 antihistamines vs placebo under natural exposure to Japanese cedar pollen. Ann Allerg Asthma Im. 2005;94(4):457–464. | 6 |
| Institut fur Atemwegsforschung Gmb H. Placebo controlled pilot study on the efficacy of levocetirizine 5 mg in reducing symptoms, airway resistance, and sleep impairment in patients with persistent allergic rhinitis [completed]. ClinicalTrials.gov. | 7 |
| Klimek L. Cintinuous intake of levocetirizine for 6 months has no relevant effect on laboratory values: the XPERT trial. 15th Annual Congress of the European Respiratory Society (ERS). 2005;17–21 September,. 2005. Copenhagen, Denmark. European Respiratory Journal 26(49 (Suppl)):370s. | 5 |
| Lee DK, Gray RD, Robb FM, Fujihara S, Lipworth BJ. A placebo-controlled evaluation of butterbur and fexofenadine on objective and subjective outcomes in perennial allergic rhinitis. Clin Exp Allergy. 2004;34(4):646–649. | 6 |
| Meltzer E, Banov C, Halverson P, Weiler J, Woehler T, Hemsworth G. Comparison of azelastine, clemastine fumarate and placebo for treatment of perennial allergic rhinitis. Ann Allergy. 1990;64(78). | 4 |
| Patel P, Philip G, Yang W, et al. Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis. Ann Allerg Asthma Im. 2005;95(6):551–557. | 3 |
| Pearlman DS, Grossman J, Meltzer EO. Histamine skin test reactivity following single and multiple doses of azelastine nasal spray in patients with seasonal allergic rhinitis. Ann Allerg Asthma Im. 2003;91(3):258–262. | 2 |
| Sanofi A. A single-center, randomized, double-blind, placebo-controlled, two-way crossover study designed to evaluate the efficacy of fexofenadine HCl 180 mg for preventing and controlling cat allergy symptoms [completed]. ClinicalTrials.gov | 7 |
| Satish U, Streufert S, Dewan M, Voort SV. Improvements in simulated real-world relevant performance for patients with seasonal allergic rhinitis: impact of desloratadine. Allergy. 2004;59(4):415–420. | 6 |
| Schering Plough, Double-blind, randomized, placebo-controlled, parallel-group, multicenter/multinational, efficacy and safety study of desloratadine 5 mg in the treatment of subjects with allergic rhinitis who meet the criteria for intermittent allergic rhinitis (IAR) [completed]. ClinicalTrials.gov | 6 |
| Schering Plough, Double-blind, randomized, placebo-controlled, parallel-group, multicenter/multinational, efficacy and safety study of desloratadine 5 mg in the treatment of subjects with allergic rhinitis who meet the criteria for persistent allergic rhinitis (PER) [completed]. ClinicalTrials.gov | 6 |
| Siebenhaar F, Degener F, Zuberbier T, Martus P, Maurer M. High-dose desloratadine decreases wheal volume and improves cold provocation thresholds compared with standard-dose treatment in patients with acquired cold urticaria: a randomized, placebo-controlled, crossover study. Journal of Allergy & Clinical Immunology. 2009;123(3):672–679. | 6 |
| Simons FE, Johnston L, Simons KJ. Clinical pharmacology of the H1-receptor antagonists cetirizine and loratadine in children. Pediatric Allergy & Immunology. 2000;11(2):116–119. | 6 |
| Torkildsen GL, Gomes P, Welch D, Gopalan G, Srinivasan S. Evaluation of desloratadine on conjunctival allergen challenge-induced ocular symptoms. Clin Exp Allergy. 2009;39(7):1052–1059. | 4 |
| Ucb. A multi-center, randomized, double-blind, placebo-controlled, parallel-A multi-center, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and impact on health-related quality of life of levocetirizine 5 mg once daily given for 2 weeks in subjects 18 yr of age and older with seasonal allergic rhinitis [completed]. ClinicalTrials.gov. | 5 |
| Ucb. A multi-center, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and impact on health-related quality of life of levocetirizine 5 mg once daily given for 2 weeks in subjects 18 yr of age and older with seasonal allergic rhinitis [completed]. ClinicalTrials.gov. | 5 |
| Ucb. A multi-center, randomized, double blind, placebo controlled parallel group study of the safety of levocetirizine dihydrochloride oral liquid formulation b.i.d dosing in children aged 1 to < 6 years suffering from allergic rhinitis or chronic urticaria of unknown origin [completed]. ClinicalTrials.gov. | 5 |
- Excluded studies in Update 2 - Drug Class Review: Newer AntihistaminesExcluded studies in Update 2 - Drug Class Review: Newer Antihistamines
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