Trial Outcomes & Findings for An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis and Intermittent Asthma (NCT NCT00599027)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

51 participants

Primary outcome timeframe

Baseline and 28 days of treatment

Results posted on

2024-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Mometasone Furoate Nasal Spray Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.	Placebo Nasal Spray Placebo nasal spray once daily (two puffs per nostril) in the morning.
Overall Study STARTED	26	25
Overall Study COMPLETED	25	22
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Mometasone Furoate Nasal Spray Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.	Placebo Nasal Spray Placebo nasal spray once daily (two puffs per nostril) in the morning.
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	0	1
Overall Study Treatment Failure	0	1

Baseline Characteristics

An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis and Intermittent Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mometasone Furoate Nasal Spray n=26 Participants Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.	Placebo Nasal Spray n=25 Participants Placebo nasal spray once daily (two puffs per nostril) in the morning.	Total n=51 Participants Total of all reporting groups
Age, Continuous	40.5 years STANDARD_DEVIATION 13.42 • n=5 Participants	43.0 years STANDARD_DEVIATION 16.62 • n=7 Participants	41.7 years STANDARD_DEVIATION 14.97 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 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.

Outcome measures

Outcome measures
Measure	Mometasone Furoate Nasal Spray n=26 Participants Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.	Placebo Nasal Spray n=25 Participants Placebo nasal spray once daily (two puffs per nostril) in the morning.
The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment. Baseline	25.3 units on a scale Standard Deviation 10.03	26.7 units on a scale Standard Deviation 18.89
The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment. Endpoint after 28 days of treatment	-10.3 units on a scale Standard Deviation 7.15	0.4 units on a scale Standard Deviation 12.32

Adverse Events

Mometasone Furoate Nasal Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Nasal Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER