Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00783224
Other study ID # P04512
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2005
Est. completion date December 2005

Study information

Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo mometasone, active fluticasone, or placebo fluticasone.


Recruitment information / eligibility

Status Completed
Enrollment 351
Est. completion date December 2005
Est. primary completion date November 2005
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: Patients with perennial allergic rhinitis meeting all of the followings. - Patients with symptoms of perennial allergic rhinitis, the severity of which is moderate or severer according to the severity grading provided in the "Guidelines for the Management of Allergic Rhinitis in Japan" (partly modified) with the 4-nasal symptom score of 4 or over at informed consent and during the pre-treatment observation period - Patients with positive reaction to the eosinophil count in nasal discharge or nasal challenge test in addition to the skin test or specific IgE antibody test - Outpatients aged 16 years or over at informed consent - Patients in either sex - Patients (or their legal representatives in case of patients aged under 20 years) capable of giving written informed consent - Patients capable of recording nasal allergy diary every day Exclusion Criteria: - Patients with a complication of tuberculous diseases or lower respiratory tract infections, and those with a complication of otorhinolaryngeal infections(acute upper respiratory tract inflammation, acute laryngopharyngitis, acute tonsillitis, etc.) requiring treatments judged by the investigator (subinvestigator) at the time of enrollment to randomization - Patients with a complication of infection or systemic mycosis for which no effective antibiotics are available - Patients with a complication of recurrent epistaxis - Patients with uncured nasal septal ulcer, operated nose or nasal trauma. - Patients with a history of hypersensitivity to steroids and any ingredients of the study drugs - Pregnant, lactating or possibly pregnant patients or the patients who themselves or whose partners wish to become pregnant during the study - Patients with severe hepatic or renal disorder, heart or blood disease, diabetes mellitus, hypertension, or other serious complication, suffering from problems with systemic condition - Patients who have pollens as multiple allergens and the period from 7 days before enrollment to randomization to completion of the treatment period coincides with the period of scattering of relevant pollens - Patients with a complication of vasomotor rhinitis or eosinophilic rhinitis - Patients with a complication of a nasal disease (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, or septal deviation) which may interfere with efficacy evaluation of the study drugs - Patients with a complication of a disease (acute upper respiratory tract inflammation, acute laryngitis or acute tonsillitis, etc.) of severity affecting nasal symptoms within 7 days before enrollment - Patients who have previously received MF nasal spray - Patients who used FP nasal spray within 28 days before initiation of the pre-treatment observation period (7 days before enrollment to randomization) - Patients who have participated in clinical trials of other investigational product(s) within 120 days (4 months) before obtaining informed consent or participating at present - Patients in whom prior medication expected to be effective for allergic rhinitis was not drawn long enough before initiation of treatment with the investigational product or the preceding medication cannot be withdrawn - Patients who are being treated with specific desensitization therapy or nonspecific allassotherapy or in whom such the therapy was withdrawn within 90 days (3 months) before obtaining informed consent (except for patients receiving the maintenance therapy at present in whom the therapy began more than 180 days (6 months) before obtaining the informed consent) - Other patients whom the investigator or the subinvestigator judged to be inappropriate for participation in the present study

Study Design


Intervention

Drug:
Placebo for MF
Placebo to mometasone furoate nasal spray, indistinguishable from mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
Placebo for FP
Placebo to fluticasone nasal spray, indistinguishable from fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks
Mometasone
Mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
Fluticasone
Fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

N. Sou et. al; Allergology & Immunology 16(3) page 394-413, (2009.02) -Japanese language journal

Outcome

Type Measure Description Time frame Safety issue
Primary Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points. Baseline to 2 weeks of treatment
See also
  Status Clinical Trial Phase
Completed NCT01654536 - A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR) Phase 4
Completed NCT01539304 - Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis Phase 3
Completed NCT01221285 - Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium Phase 1
Terminated NCT00491374 - Study of Nasonex® in Improving Sleep Disturbances Related to Perennial Allergic Rhinitis (Study P04909)(TERMINATED) Phase 4
Completed NCT04324918 - Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis Phase 3
Completed NCT02532179 - Subcutaneous Immunotherapy for Mouse in Adults Phase 1/Phase 2
Completed NCT01451541 - A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR). Phase 3
Enrolling by invitation NCT01062139 - Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy Phase 4
Completed NCT00405899 - Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections N/A
Completed NCT01549340 - Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022) N/A
Completed NCT01018862 - A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis Phase 3
Completed NCT00789555 - Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis Phase 4
Completed NCT00261287 - Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416) Phase 3
Completed NCT00974571 - Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246) Phase 3
Completed NCT04654702 - Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap.
Completed NCT05122143 - Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers N/A
Completed NCT01380327 - Biomarkers of Cockroach Sublingual Immunotherapy 2 Phase 1/Phase 2
Completed NCT01116778 - the Efficacy and Safety of Probiotics eN-Lac® Capsules of Children With Perennial Allergic Rhinitis Phase 3
Completed NCT00359216 - The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726) Phase 4
Completed NCT01127620 - Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension Phase 3