Efficacy and safety of once-daily ciclesonide nasal spray in children with allergic rhinitis

Pediatric Asthma, Allergy and Immunology

Volumn 21, Issue 2, 2008, Pages 73-82

  Berger, William E ^a   Nayak, Anjuli ^b   Lanier, Bobby Q ^c   Kaiser, Harold B ^d   LaForce, Craig ^e   Darken, Patrick ^f   Hall, Nancy ^f   Wingertzahn, Mark ^f  

^a Allergy & Asthma Associates of Southern California   (United States)

^b Sneeze Wheeze and Itch Associates LLC ^*  (United States)

^c North Texas Institute for Clinical Trials   (United States)

^d Allergy and Asthma Specialists   (United States)

^e North Carolina Clinical Research   (United States)

^f ALTANA Pharma US   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CICLESONIDE; DESISOBUTYRYL CICLESONIDE; DRUG METABOLITE; HYDROCORTISONE; PLACEBO; UNCLASSIFIED DRUG;

ARTICLE; ASTHMA; CAREGIVER; CHILD; CLINICAL TRIAL; COMPARATIVE STUDY; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; EPISTAXIS; FEMALE; FEVER; HAY FEVER; HEADACHE; HUMAN; HYDROCORTISONE URINE LEVEL; MAJOR CLINICAL STUDY; MALE; MEDICAL ASSESSMENT; NOSE DISEASE; PERENNIAL RHINITIS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SINUSITIS; SORE THROAT; THROAT IRRITATION; UPPER RESPIRATORY TRACT INFECTION; VOMITING;

EID: 51849105685     PISSN: 08831874     EISSN: None     Source Type: Journal    
DOI: 10.1089/pai.2007.0022.73     Document Type: Article

References (32)

1. Skoner DP. Allergic rhinitis: definition, epidemiology, pathophysiology, detection, and diagnosis. J Allergy Clin Immunol 2001; 108:S2-S8.
2. Arshad SH. Indoor allergen exposure in the development of allergy and asthma. Curr Allergy Asthma Rep 2003; 3:115-120.
3. Stempel DA, Woolf R. The cost of treating allergic rhinitis. Curr Allergy Asthma Rep 2002; 2:223-230.
4. HealthSTAR Communications, Inc., in partnership with Schulman, Ronca and Bucuvalas, Inc. Allergies in America: a landmark survey of nasal allergy sufferers, executive summary. Florham Park, NJ: Altana Pharma US, Inc., 2006.
5. Bousquet J , Van Cauwenberge P, Khaltaev N, Aria Working Group, World Health Organization. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol 2001; 108:S147-S334.
6. Cave A, Arlett P, Lee E. Inhaled and nasal corticosteroids: factors affecting the risks of systemic adverse effects. Pharmacol Ther 1999; 83:153-179.
7. Nave R, Fisher R, Zech K. In vitro metabolism of ciclesonide in human lung and liver precision-cut tissue slices. Biopharm Drug Dispos 2006; 27:197-207.
8. Nave R , Meyer W, Fuhst R , Zech K. Formation o f fatty acid conjugates of ciclesonide active metabolite in the rat lung after 4-week inhalation of ciclesonide. Pulm Pharmacol Ther 2005; 18:390-396.
9. Wingertzahn MA, Sato H, Nave R, Nonaka T, Mochizuki T, Takahama S, Kondo S. Esterases involved in the metabolism of ciclesonide (CIC) in human nasal epithelial cells (HNEC) [abstract]. J Allergy Clin Immunol 2006; 117:S167. Abstract 650.
10. Wingertzahn MA, Nonaka T, Mochizuki T, Sato H, Kondo S . Reversibility of desisobutyryl-ciclesonide conversion to fatty acid conjugates [abstract]. J Allergy Clin Immunol 2006; 117:S167. Abstract 652.
11. Stoeck M, Riedel R, Hochhaus G, Hafner D, Masso JM, Schmidt B, Hatzelmann A, Marx D, Bundschuh DS. In vitro and in vivo anti-inflammatory activity of the new glucocorticoid ciclesonide. J Pharmacol Exp Ther 2004; 309:249-258.
12. Nave R, Bethke TD, van Marle SP, Zech K. Pharmacokinetics of [14C]ciclesonide after oral and intravenous administration to healthy subjects. Clin Pharmacokinet 2004; 43:479-486.
13. Rohatagi S, Luo Y, Shen L, Guo Z, Schemm C, Huang Y, Chen K, David M, Nave R, King SP. Protein binding and its potential for eliciting minimal systemic side effects with a novel inhaled corticosteroid, ciclesonide. Am J Ther 2005; 12:201-209.
14. Rohatagi S, Arya V, Zech K, Nave R, Hochhaus G, Jensen BK, Barrett JS. Population pharmacokinetics and pharmacodynamics of ciclesonide. J Clin Pharmacol 2003; 43:365-378.
15. Ratner PH, Wingertzahn MA, van Bavel JH, Hampel F, Darken PF, Shah T. Efficacy and safety of ciclesonide nasal spray for the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol 2006; 118:1142-1148.
16. Meltzer EO, Kunjibettu S, Hall N, Wingertzahn MA, Murcia C, Berger W, LaForce C. Efficacy and safety of ciclesonide, 200 microg once daily, for the treatment of perennial allergic rhinitis. Ann Allergy Asthma Immunol 2007; 98:175-181.
17. Chervinsky P, Kunjibettu S, Miller DL, Prenner BM, Raphael G, Hall N, Shah T. Long-term safety and efficacy of intranasal ciclesonide in adult and adolescent patients with perennial allergic rhinitis. Ann Allergy Asthma Immunol 2007; 99:69-76.
18. Nave R, Wingertzahn MA, Brookman S, Kaida S, Matsunaga T. Safety, tolerability, and exposure of c iclesonide nasal spray in healthy and asymptomatic subjects with seasonal allergic rhinitis. J Clin Pharmacol 2006; 46:461-467.
19. Ratner PH, Wingertzahn MA, van Bavel JH, Hampel F, Darken PF, Hellbardt S , Brookman S, Shah T. E ffectiveness o f ciclesonide nasal spray in the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol 2006; 97:657-663.
20. Berger WE. Allergic rhinitis in children: diagnosis and management strategies. Paediatr Drugs 2004; 6:233-250.
21. Rhinocort Aqua® (budesonide) nasal spray 32 mcg [package insert]. Wilmington, DE: AstraZeneca LP, 2004.
22. Nasonex® (mometasone furoate monohydrate) nasal spray, 50 mcg [package insert]. Kenilworth, NJ: Schering Corp., 2005.
23. Flonase® (fluticasone propionate) nasal spray, 50 mcg [package insert]. Research Triangle Park, NC: GlaxoSmithKline, 2004.
24. Zyrtec® (cetirizine hydrochloride) tablets, chewable tablets and syrup [package insert]. New York: Pfizer Labs, 2006.
25. Astelin® (azelastine hydrochloride) nasal spray, 137 mcg [package insert]. Somerset, NJ: MedPointe Healthcare, Inc., 2006.
26. Nasacort® (triamcinolone acetonide) nasal aerosol [package insert]. Bridgewater, NJ: Aventis Pharmaceuticals Inc., 2004.
27. Kim K, Weiswasser M, Nave R, Ratner P, Nayak A, Herron J, Hall N, Wingertzahn M. Safety of once-daily ciclesonide nasal spray in children 2 to 5 years of age with perennial allergic rhinitis. Ped Asthma Allergy Immunol 2007; 20:229-242.
28. Waddell AN, Patel SK, Toma AG, Maw AR. Intranasal steroid sprays in the treatment of rhinitis: is one better than another? J Laryngol Otol 2003; 117:843-845.
29. Baena-Cagnani CE. Safety and tolerability of treatments for allergic rhinitis in children. Drug Saf 2004; 27:883-898.
30. Kim K T, Rabinovitch N , Uryniak T, Simpson B , O'Dowd L, Casty F. Effect of budesonide aqueous nasal spray on hypothalamic-pituitary-adrenal axis function in children with allergic rhinitis. Ann Allergy Asthma Immunol 2004; 93:61-67.
31. Maspero JF, Rosenblut A, Finn A Jr, Lim J, Wu W, Philpot E . Safety and efficacy of fluticasone furoate in pediatric patients with perennial allergic rhinitis. Otolaryngol Head Neck Surg 2008; 138:30-37.
32. Kaiser HB, Naclerio RM, Given J, Toler TN, Ellsworth A, Philpot EE. Fluticasone furoate nasal spray: a single treatment option for the symptoms of seasonal allergic rhinitis. J Allergy Clin Immunol 2007; 119:1430-1437.