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The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate nasal spray) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma. A secondary objective is to evaluate the efficacy of Nasonex in relieving the subject's symptoms of allergic rhinitis and asthma.
The primary objective is to explore the efficacy of mometasone furoate nasal spray (MFNS) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). In addition, there are two secondary objectives. The first secondary objective is to evaluate the efficacy of MFNS in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Upper Airways Score, the Rhinasthma Lower Airways Score, and the Rhinasthma Respiratory Allergy Impact Score. The second secondary objective is to evaluate the efficacy of MFNS in relieving the subject's symptoms of allergic rhinitis and asthma as measured by the Total 5 Symptoms Score (T5SS) and the Global Symptom Score (T5SS+asthma symptoms) and by the use of rescue medication on demand.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone furoate nasal spray | Experimental | Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. |
|
| Placebo nasal spray | Placebo Comparator | Placebo nasal spray once daily (two puffs per nostril) in the morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone furoate nasal spray (MFNS) | Drug | Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment. | To explore the efficacy of mometasone furoate nasal spray in comparison with placebo in improving the quality of life of subjects with moderate-severe PER and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). The Rhinasthma is a questionnaire that consists of 30 items and for each of them subjects had to indicate on a Likert scale (1=not at all; 5=very much) the degree of limitation or discomfort caused by each problem. Possible total best score = 150 and possible total worst score = 30. | Baseline and 28 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21121983 | Result | Baiardini I, Villa E, Rogkakou A, Pellegrini S, Bacic M, Compalati E, Braido F, Le Grazie C, Canonica GW, Passalacqua G. Effects of mometasone furoate on the quality of life: a randomized placebo-controlled trial in persistent allergic rhinitis and intermittent asthma using the Rhinasthma questionnaire. Clin Exp Allergy. 2011 Mar;41(3):417-23. doi: 10.1111/j.1365-2222.2010.03660.x. Epub 2010 Dec 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mometasone Furoate Nasal Spray | Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. |
| FG001 | Placebo Nasal Spray | Placebo nasal spray once daily (two puffs per nostril) in the morning. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mometasone Furoate Nasal Spray | Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. |
| BG001 | Placebo Nasal Spray | Placebo nasal spray once daily (two puffs per nostril) in the morning. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment. | To explore the efficacy of mometasone furoate nasal spray in comparison with placebo in improving the quality of life of subjects with moderate-severe PER and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). The Rhinasthma is a questionnaire that consists of 30 items and for each of them subjects had to indicate on a Likert scale (1=not at all; 5=very much) the degree of limitation or discomfort caused by each problem. Possible total best score = 150 and possible total worst score = 30. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 28 days of treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mometasone Furoate Nasal Spray | Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Placebo nasal spray | Drug | Placebo nasal spray once daily (two puffs per nostril) in the morning. |
|
|
| Treatment Failure |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo Nasal Spray |
Placebo nasal spray once daily (two puffs per nostril) in the morning. |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Placebo Nasal Spray | Placebo nasal spray once daily (two puffs per nostril) in the morning. | 0 | 25 | 0 | 25 |
The PI agrees not to publish or publicly present any interim results of the study without prior written consent of the sponsor. The PI further agrees to provide 45 days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of abstracts or manuscripts for publication.
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |