None listed
Conditions
Interventions
200 mcg QD of mometasone furoate in nasal spray for 4 months
Group name:Group 3 Type of group
Placebo in nasal spray for 4 months
Group 1 Type of group
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • The subjects must have a diagnosis of bilateral nasal polyps in both the Selection Visit and the Start Visit. The nasal polyps on each side (left and right) should be Grade 1, 2 or 3. • Subjects must present clinically significant nasal congestion / obstruction, with an instant morning rating> 2 in each of the last seven days of the two-week selection-start period. Symptoms will be scored once a day in the morning. • The subjects must be 18 years of age and older and can be of both sexes and any race. • The subjects must have a good state of health and not suffer from any clinically significant disease that could interfere with the study schedule or procedures, or that could compromise the subject´s safety. • Subjects must give their consent in writing and be able to comply with dose and visit schedules. • Asthmatic subjects who require treatment with inhaled corticosteroids to maintain pulmonary function should follow a dosing regimen that does not exceed 840 mcg of beclomethasone per day, or its equivalent, at least during the entire month before the Selection. Said regime must remain stable throughout the course of the study.
Exclusion criteria
Exclusion criteria: • Women who can conceive and who are not using medically acceptable methods of contraception. • Women who are pregnant or breastfeeding. • Subjects with a history of allergic rhinitis in the last two years. • Subjects who have undergone nasal or sinus surgery in the last 6 months. • Subjects with presumed fibrotic nasal polyposis. • Subjects who have undergone three or more nasal surgeries. • Subjects who have undergone ethmoidectomies. • Subjects with complete nasal obstruction (Grade 4 nasal polyposis). • Subjects with non-stabilized asthma requiring administration of inhaled corticosteroids at doses of 840 mcg / day of beclomethasone (or its equivalent). Asthmatic subjects will be excluded if the FEV1 is less than 70% of the predicted and if they have a history of asthma attacks that could have been fatal. • Subjects who present current sinusitis or concurrent nasal infection, or who have had a nasal infection in the two weeks prior to the Screening Visit. • Subjects with rhinitis medicamentosa. • Subjects with Churg-Strauss syndrome (vasculitis, asthma, fever and eosinophilia). • Subjects with Young´s syndrome (sinus-pulmonary infections and obstructive azoospermia). • Subjects that present any clinically relevant abnormal result in the vital signs of the Selection or the Start, or any clinically significant abnormal result in the electrocardiograms. • Subjects who have received some treatment with intranasal steroids in the two weeks before the Selection. • Subjects who have used a research drug in the 30 days prior to Visit 1. • Immunocompromised subjects, with cystic fibrosis, primary ciliary dysfunction or Kartagener syndrome (immobile cilia), glaucoma or a history of posterior subcapsular cataract, or clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, hematologic or neurological diseases that, at the discretion of the Researcher, may interfere with the evaluation of the therapy. • Subjects hypersensitive to corticosteroids, or allergic to more than two kinds of medications. • Subjects that have not complied with the depuration periods of the medications, established in the protocol, before Visit 1. • Subjects who present upper respiratory tract infection at present or who have had an upper respiratory tract infection in the two weeks prior to the Screening Visit. • Subjects with deviation of the nasal septum that requires corrective surgery. • Subjects with perforation of the nasal septum. • Members of the study staff, or subjects related to a member of the staff of the center who intervenes directly in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluation of signs / symptoms Measure:Index of modification produced in the congestion/obstruction during the first eight weeks of the treatment period. Timepoints:On the first day and every monthly visit for 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluation of signs / symptoms Measure:Presence of anterior and posterior rhinorrhea, congestion / obstruction and loss of smell, as well as the objective qualification of polyps Timepoints:On the first day and every monthly visi ; Outcome name:The subjects will evaluate and record the signs / symptoms and the maximum inspiratory nasal flow every day in the journals. Measure:Maximum inspiratory nasal flow (PNIF) Timepoints:Day 1, 8. Month 1, 2, 3, 4 ; Outcome name:Evaluation of therapeutic response through clinical examination Measure:Therapeutic response Timepoints:On visits 4, 5, 6, 7 ; Outcome name:Scales of the SF-36 Survey, together with the WPAI Questionnaire and the generic Questionnaire on Satisfaction with treatment. Measure:Quality of life related to health Timepoints:Month 4 | — |
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed