Perennial Allergic Rhinitis
Conditions
Brief 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.
Interventions
DRUGPlacebo 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
DRUGPlacebo 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
DRUGMometasone
Mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
DRUGFluticasone
Fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks | Baseline to 2 weeks of treatment | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Furoate Placebo (PLAMF) Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray | 32 |
| Fluticasone Propionate Placebo (PLAFP) Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray | 34 |
| Mometasone Furoate (MF) Mometasone furoate nasal spray 200 μg/day(QD) | 143 |
| Fluticasone Propionate (FP) Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID) | 142 |
| Total | 351 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Discarded the Investigational Drug Used | 0 | 0 | 0 | 1 |
| Overall Study | Inappropriate as a study subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Mometasone Furoate Placebo (PLAMF) | Fluticasone Propionate Placebo (PLAFP) | Mometasone Furoate (MF) | Fluticasone Propionate (FP) | Total |
|---|---|---|---|---|---|
| Age, Customized 20-29 years old | 20 participants | 13 participants | 59 participants | 76 participants | 168 participants |
| Age, Customized <20 years old | 1 participants | 0 participants | 7 participants | 11 participants | 19 participants |
| Age, Customized 30-39 years old | 11 participants | 16 participants | 54 participants | 33 participants | 114 participants |
| Age, Customized 40-59 years old | 0 participants | 5 participants | 19 participants | 21 participants | 45 participants |
| Age, Customized >=60 years old | 0 participants | 0 participants | 4 participants | 1 participants | 5 participants |
| Sex: Female, Male Female | 20 Participants | 24 Participants | 99 Participants | 87 Participants | 230 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 44 Participants | 55 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 66 | 11 / 143 | 4 / 142 |
| serious Total, serious adverse events | 0 / 66 | 0 / 143 | 1 / 142 |
Outcome results
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.
Time frame: Baseline to 2 weeks of treatment
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Placebo (PLAMF) | Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks | Baseline | 7.84 Units on a scale | Standard Error 0.25 |
| Mometasone Furoate Placebo (PLAMF) | Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks | Two Weeks | 1.63 Units on a scale | Standard Error 0.37 |
| Fluticasone Propionate Placebo (PLAFP) | Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks | Two Weeks | 1.74 Units on a scale | Standard Error 0.35 |
| Fluticasone Propionate Placebo (PLAFP) | Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks | Baseline | 8.41 Units on a scale | Standard Error 0.29 |
| Mometasone Furoate (MF) | Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks | Baseline | 8.27 Units on a scale | Standard Error 0.15 |
| Mometasone Furoate (MF) | Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks | Two Weeks | 3.90 Units on a scale | Standard Error 0.17 |
| Fluticasone Propionate (FP) | Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks | Baseline | 8.29 Units on a scale | Standard Error 0.16 |
| Fluticasone Propionate (FP) | Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks | Two Weeks | 3.69 Units on a scale | Standard Error 0.17 |
p-value: 0.0001ANCOVA
p-value: 0.0001ANCOVA