Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis (Study P05106)(COMPLETED)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00468312
• Collaborator: (none)
• Enrollment: 429
• Arms: 2
• Duration (Months): 4

Study Details

Study Description

Brief Summary

This study is designed to assess the effectiveness of mometasone furoate nasal spray (MFNS) once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total symptom score.

Condition or Disease	Intervention/Treatment	Phase
Seasonal Allergic Rhinitis	Drug: Mometasone furoate nasal spray; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 429 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mometasone Furoate Nasal Spray (MFNS) 200 mcg daily	Drug: Mometasone furoate nasal spray; Two sprays (50 mcg/spray) in each nostril (200 mcg daily) in the morning; Other Names: Nasonex
Placebo Comparator: Placebo Two sprays in each nostril in the morning	Drug: Placebo; Two sprays in each nostril in the morning

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 [Screening through 15 days daily]

   TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.

2. Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 [Screening through 15 days daily]

   TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9.

Secondary Outcome Measures

1. Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 [Screening through 15 days daily]

   Nasal congestion was one of the symptoms measures in the TNSS and was scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.

2. Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) [Baseline and 15 days]

   The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.

3. Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 [Screening through 15 days daily]

   Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must be 12 years of age or older, of either sex and of any race.

• Must have at least a 2-year documented history of SAR which exacerbates during the study season.

• Must have a positive skin-prick test response to an appropriate seasonal allergen at Screening (Visit 1). IgE-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.

• Must be clinically symptomatic at the Screening Visit.

• Must be clinically symptomatic at the Baseline Visit.

• Must be in general good health as confirmed by routine clinical and laboratory testing and ECG results. Clinical laboratory test (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.

• Must be free of any clinically significant disease, other than SAR, that would interfere with the study evaluations.

• A subject and/or a parent/guardian must be willing to give written informed consent and must be able to adhere to dosing and visit schedules and meet study requirements.

• A female subject of childbearing potential must have a negative serum pregnancy test (HCG) at Screening. Nonsterile and premenopausal female subjects must be using a medically acceptable method of birth control, ie, double barrier method, oral contraceptive, hormonal implant, or depot injectable prior to Screening and during the study.

Exclusion Criteria:

• A history of anaphylaxis and/or other severe local reaction(s) to skin testing.

• A subject with asthma who require chronic use of inhaled or systemic corticosteroids.

• Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.

• A subject with rhinitis medicamentosa.

• A history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays.

• A subject who have had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who have had a viral upper respiratory infection within 7 days before the Screening Visit.

• A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.

• A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.

• Use of any drug in an investigational protocol in the 30 days before the Screening Visit.

• A subject on immunotherapy (desensitization therapy), unless the subject is on a regular maintenance schedule prior to the Screening Visit and will stay on this schedule for the remainder of the study. A subject may not receive desensitization treatment within 24 hours before any visit.

• Pregnant or nursing females.

• Family member of the investigation study staff.

• Current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject's participation in the study. Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism, or excretion of the study drug or interfere with the subject's ability to complete or reliably complete the diaries.

• Significant medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment.

• A subject whose ability to provide informed consent is compromised.

• A subject with a history of noncompliance with medications or treatment

protocols.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00468312
• Other Study ID Numbers: P05106
• First Posted: May 2, 2007
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Mometasone Furoate

Study Results

Participant Flow

Arm/Group Title	Mometasone Furoate Nasal Spray (MFNS)	Placebo
Arm/Group Description	MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Two sprays in each nostril once daily
Period Title: Overall Study
STARTED	220	209
COMPLETED	216	204
NOT COMPLETED	4	5

Baseline Characteristics

Arm/Group Title	Mometasone Furoate Nasal Spray (MFNS)	Placebo	Total
Arm/Group Description	MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Two sprays in each nostril once daily	Total of all reporting groups
Overall Participants	220	209	429
Age, Customized (participants) [Number]
6 - <12 years	0 0%	1 0.5%	1 0.2%
12 - <18 years	31 14.1%	24 11.5%	55 12.8%
18 - <65 years	184 83.6%	181 86.6%	365 85.1%
>=65 years	5 2.3%	3 1.4%	8 1.9%
Sex: Female, Male (Count of Participants)
Female	132 60%	125 59.8%	257 59.9%
Male	88 40%	84 40.2%	172 40.1%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15
Description	TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.
Time Frame	Screening through 15 days daily

Outcome Measure Data

Analysis Population Description

All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.

Arm/Group Title	Mometasone Furoate Nasal Spray (MFNS)	Placebo
Arm/Group Description	MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Two sprays in each nostril once daily
Measure Participants	220	208
Baseline TNSS	9.31 (1.60)	9.31 (1.60)
Change from Baseline in TNSS	-2.54 (1.99)	-1.66 (1.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mometasone Furoate Nasal Spray (MFNS), Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.

2. Primary Outcome

Title	Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15
Description	TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9.
Time Frame	Screening through 15 days daily

Outcome Measure Data

Analysis Population Description

All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.

Arm/Group Title	Mometasone Furoate Nasal Spray (MFNS)	Placebo
Arm/Group Description	MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Two sprays in each nostril once daily
Measure Participants	220	208
Baseline TOSS	6.78 (1.46)	6.74 (1.46)
Change from Baseline in TOSS	-1.71 (1.60)	-1.37 (1.60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mometasone Furoate Nasal Spray (MFNS), Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.026
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.

3. Secondary Outcome

Title	Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15
Description	Nasal congestion was one of the symptoms measures in the TNSS and was scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.
Time Frame	Screening through 15 days daily

Outcome Measure Data

Analysis Population Description

All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.

Arm/Group Title	Mometasone Furoate Nasal Spray (MFNS)	Placebo
Arm/Group Description	MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Two sprays in each nostril once daily
Measure Participants	220	208
Baseline Nasal Congestion Score	2.60 (0.38)	2.62 (0.38)
change from Baseline in Nasal Congestion Score	-0.59 (0.53)	-0.39 (0.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mometasone Furoate Nasal Spray (MFNS), Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.

4. Secondary Outcome

Title	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)
Description	The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.
Time Frame	Baseline and 15 days

Outcome Measure Data

Analysis Population Description

The RQLQ tool is only validated in participants greater than or equal to 18 years of age. The analysis population included subjects who were randomized to treatment, answered the RQL questionnaire both at baseline and post baseline visits and were at least 18 years of age.

Arm/Group Title	Mometasone Furoate Nasal Spray (MFNS)	Placebo
Arm/Group Description	MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Two sprays in each nostril once daily
Measure Participants	189	182
Baseline RQLQ Total Score	4.27 (1.01)	4.28 (1.01)
Change from Baseline in RQLQ Total Score	-1.81 (1.36)	-1.08 (1.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mometasone Furoate Nasal Spray (MFNS), Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.

5. Secondary Outcome

Title	Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15
Description	Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.
Time Frame	Screening through 15 days daily

Outcome Measure Data

Analysis Population Description

All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.

Arm/Group Title	Mometasone Furoate Nasal Spray (MFNS)	Placebo
Arm/Group Description	MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.	Two sprays in each nostril once daily
Measure Participants	220	208
Baseline PNIF	93.12 (41.3)	91.96 (41.3)
Change from Baseline in PNIF	16.55 (36.9)	12.59 (36.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mometasone Furoate Nasal Spray (MFNS), Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.269
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.

Adverse Events

Arm/Group Title	Mometasone Furoate Nasal Spray (MFNS)		Placebo
Arm/Group Description	MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.		Two sprays in each nostril once daily
All Cause Mortality
	Mometasone Furoate Nasal Spray (MFNS)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Mometasone Furoate Nasal Spray (MFNS)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/220 (0%)		0/209 (0%)
Other (Not Including Serious) Adverse Events
	Mometasone Furoate Nasal Spray (MFNS)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/220 (0%)		0/209 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 45 days from the time submitted to the sponsor for review. If the parties disagree on the communication, the investigator and sponsor's represnetatives will meet for the purpose of making a good faith effort to discuss and resolve any such issues or disagreement.