Randomised, crossover clinical trial, in healthy volunteers, to compare the systemic availability of two topical intranasal budesonide formulations

Trials

Volumn 9, Issue , 2008, Pages

  Algorta, Jaime ^a,b,c   Pena, Maria Angeles ^a,c   Francisco, Silvia ^a,c   Abajo, Zurine ^a,c   Sanz, Emilio ^a,c  

^a TECNALIA RESEARCH AND INNOVATION   (Spain)

^b UNIVERSITY OF THE BASQUE COUNTRY UPV EHU   (Spain)

^c European Academy of Allergy and Clinical Immunology   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

BUDESONIDA NASAL 64; BUDESONIDE; RHINOCORT 64;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG EXCRETION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG URINE LEVEL; FEMALE; HUMAN; HUMAN EXPERIMENT; HYPOTHALAMUS HYPOPHYSIS ADRENAL SYSTEM; LYMPHOCYTOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MEAN RESIDENCE TIME; NORMAL HUMAN; PHARYNGITIS; PHARYNX DISEASE; PLASMA CONCENTRATION-TIME CURVE; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RANK SUM TEST; SINGLE BLIND PROCEDURE; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; VOLUNTEER;

EID: 47749129684     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-9-34     Document Type: Article

References (17)

1. Lumry WR A review of the preclinical and clinical data at newer intranasal steroids used in the treatment of allergic rhinitis J Allergy Clin Immunol 1999, 104(4 Pt 1):S150-8 10.1016/S0091-6749(99)70311-8 10518812
2. Lipworth BJ Jackson CM Safety of inhaled and intranasal corticosteroids: lessons for the new millennium Drug Saf 2000, 23(1):11-33 10.2165/ 00002018-200023010-00002 10915030
3. Möller C Ahlström H Henricson KA Malmqvist LA Akerlund A Hildebrand H Safety of nasal budesonide in the long-trem treatment of children with perennial rhinitis Clin Exp Allergy 2003, 33:816-822 10.1046/j.1365-2222.2003.01689.x 12801318
4. Baena-Cagnani CE Safety and tolerability of treatments for allergic rhinitis in children Drug Saf 2004, 27(12):883-98 10.2165/ 00002018-200427120-00005 15366976
5. Boner AL Effects of intranasal corticosteroids on the hypothalamic-pituitary-adrenal axis in children J Allergy Clin Immnol 2001, 108(1 Suppl):S32-9 10.1067/mai.2001.115564 11449204
6. Krahnke J Skoner D Benefit and risk management for steroid treatment in upper airway diseases Curr Allergy Asthma Rep 2002, 2(6):507-12 10.1007/ s11882-002-0092-0 12359122
7. Allen DB Systemic effects of intranasal steroids: An endocrinologist's perspective J Allergy Clin Immunol 2000, 106(4 Suppl):S179-90 10.1067/ mai.2000.110038 11032642
8. Szefler SJ Pharmacokinetics of intranasal corticosteroids J Allergy Clin Immunol 2001, 108(1):S26-31 10.1067/mai.2001.115563 11449203
9. Kelly HW Pharmaceutical characteristics that influence the clinical efficacy of inhaled corticosteroids Ann Allergy Asthma Immunol 2003, 91(4):326-334 14582810
10. Thorsson L Borga O Edsbäcker S Systemic availability of budesonide after nasal administration of three different formulations: Pressurized aerosol, aqueous pump spray, and powder Br J Clin Pharmacol 1999, 47(6):619-24 2014261 10383539 10.1046/j.1365-2125.1999.00956.x
11. The European Agency for the Evaluation of Medicinal Products (EMEA) CHMP/ EWP/2455/02 Guideline on the clinical development of medicinal products for the treatment of allergic rhinoconjunctivitis London 2002
12. USA Food and Drug Administration CDER-GUIDANCE FOR INDUSTRY- Allergic rhinitis: Clinical development programs for drug products DRAFT GUIDANCE. (Clin) Rockville, MD 2000 http://www.fda.gov/cder/guidance/ index.htm
13. USA Food and Drug Administration CDER-GUIDANCE FOR INDUSTRY- Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action DRAFT GUIDANCE. (Biopharmaceutics) Rockville, MD 2003 http://www.fda.gov/cder/guidance/index.htm
14. The European Agency for the Evaluation of Medicinal Products(EMEA) CPMP/ EWP/239/95 Note for Guidance on the clinical requirements for locally applied, locally acting products containing known constituents London 1995
15. The European Agency for the Evaluation of Medicinal Products(EMEA) CPMP/ EWP/QWP/1401/98 Note for Guidance on the investigation of bioavailability and bioequivalence London 2001
16. Endrenyi L Fritsch S Yan W Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence Int J Clin Pharmacol Ther Toxicol 1991, 29(10):394-399 1748540
17. Midha KK Rawson MJ Hubbard JW The bioequivalence of highly variable drugs and drug products Int J Clin Pharmacol Ther 2005, 43(10):485-98 16240706