Biomaterial Database

A double-blind group comparative study of nedocromil sodium in the treatment of seasonal allergic rhinitis. 1988

P Bellioni, and F Salvinelli, and F Patalano, and F Ruggieri

Dept. of O.R.L., Catholic University of Rome, Italy.

Thirty-eight patients with seasonal rhinitis due to grass pollen allergy took part in this double-blind study comparing 1% nedocromil sodium and placebo. Treatment was allocated by randomised coding sheet and consisted of 1% nedocromil sodium nasal spray or placebo given four times daily for four weeks during the peak pollen season. Highly significant (p less than 0.001) differences in favour of nedocromil sodium were seen for all signs and symptoms recorded at clinical assessments, and for diary card assessments of symptoms. In addition, time to effect and patient and clinician opinions of treatment significantly (p less than 0.001) favoured nedocromil sodium. Laboratory data on blood and urine samples taken before and after treatment showed no significant effects, and both treatments were well tolerated. Nedocromil sodium 1% nasal spray taken four times daily was shown to be an effective treatment for grass pollen rhinitis.

UI	MeSH Term	Description	Entries
D008297	Male		Males
D011897	Random Allocation	A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.	Randomization,Allocation, Random
D002648	Child	A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL.	Children
D002675	Child, Preschool	A child between the ages of 2 and 5.	Children, Preschool,Preschool Child,Preschool Children
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260	Female		Females
D006255	Rhinitis, Allergic, Seasonal	Allergic rhinitis that occurs at the same time every year. It is characterized by acute CONJUNCTIVITIS with lacrimation and ITCHING, and regarded as an allergic condition triggered by specific ALLERGENS.	Hay Fever,Pollen Allergy,Pollinosis,Seasonal Allergic Rhinitis,Hayfever,Allergic Rhinitides, Seasonal,Allergic Rhinitis, Seasonal,Allergies, Pollen,Allergy, Pollen,Fever, Hay,Pollen Allergies,Pollinoses,Rhinitides, Seasonal Allergic,Rhinitis, Seasonal Allergic,Seasonal Allergic Rhinitides
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293	Adolescent	A person 13 to 18 years of age.	Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths