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Trial record 54 of 10796 for:    Placebo AND once

Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00453063
Recruitment Status : Completed
First Posted : March 28, 2007
Results First Posted : May 17, 2010
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Seasonal Allergic Rhinitis
Interventions Drug: mometasone furoate
Drug: Placebo
Enrollment 426
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mometasone Furoate Nasal Spray (MFNS) Placebo
Hide Arm/Group Description MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg. Two sprays in each nostril once daily
Period Title: Overall Study
Started 211 215
Completed 208 212
Not Completed 3 3
Reason Not Completed
Adverse Event             1             2
Withdrawal by Subject             1             1
Protocol Violation             1             0
Arm/Group Title Mometasone Furoate Nasal Spray (MFNS) Placebo Total
Hide Arm/Group Description MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg. Two sprays in each nostril once daily Total of all reporting groups
Overall Number of Baseline Participants 211 215 426
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 211 participants 215 participants 426 participants
<=18 years
18
   8.5%
30
  14.0%
48
  11.3%
Between 18 and 65 years
188
  89.1%
181
  84.2%
369
  86.6%
>=65 years
5
   2.4%
4
   1.9%
9
   2.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 211 participants 215 participants 426 participants
Female
140
  66.4%
130
  60.5%
270
  63.4%
Male
71
  33.6%
85
  39.5%
156
  36.6%
1.Primary Outcome
Title Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15
Hide Description TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, 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 Baseline and 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects 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
Hide Arm/Group Description:
MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
Two sprays in each nostril once daily
Overall Number of Participants Analyzed 209 213
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline TNSS 9.83  (1.56) 9.69  (1.56)
Change from Baseline in TNSS -2.36  (2.07) -1.71  (2.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray (MFNS), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15
Hide 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 this scale is 9.
Time Frame Baseline and 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects 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
Hide Arm/Group Description:
MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
Two sprays in each nostril once daily
Overall Number of Participants Analyzed 209 213
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline TOSS 7.07  (1.54) 7.01  (1.54)
Change from Baseline in TOSS -1.52  (1.59) -1.36  (1.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray (MFNS), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.304
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15
Hide Description Nasal congestion was one of the symptoms measured 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 Baseline and 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects 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
Hide Arm/Group Description:
MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
Two sprays in each nostril once daily
Overall Number of Participants Analyzed 209 213
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Nasal Congestion Score 2.66  (0.40) 2.64  (0.40)
Change from Baseline in Nasal Congestion Score -0.54  (0.54) -0.39  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray (MFNS), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The RQLQ tool is only validated in participants greater than or equal to 18 years of age, so it was only administered in this age group.
Arm/Group Title Mometasone Furoate Nasal Spray (MFNS) Placebo
Hide Arm/Group Description:
MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
Two sprays in each nostril once daily
Overall Number of Participants Analyzed 189 182
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline RQLQ Total Score 4.19  (0.97) 4.42  (0.97)
Change from Baseline in RQLQ Total Score -1.63  (1.37) -1.36  (1.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray (MFNS), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15
Hide 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 Baseline and 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects 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
Hide Arm/Group Description:
MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
Two sprays in each nostril once daily
Overall Number of Participants Analyzed 209 213
Least Squares Mean (Standard Deviation)
Unit of Measure: liters/minute
Baseline PNIF 89.11  (37.2) 88.85  (37.2)
Change from Baseline in PNIF 10.15  (21.1) 8.24  (21.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray (MFNS), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.356
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mometasone Furoate Nasal Spray (MFNS) Placebo
Hide Arm/Group Description MFNS 200 mcg (two sprays in each nostril) once daily (QD) 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mometasone Furoate Nasal Spray (MFNS) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/211 (0.00%)   0/215 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mometasone Furoate Nasal Spray (MFNS) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/211 (0.00%)   0/215 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00453063     History of Changes
Other Study ID Numbers: P05067
First Submitted: March 26, 2007
First Posted: March 28, 2007
Results First Submitted: February 3, 2010
Results First Posted: May 17, 2010
Last Update Posted: April 3, 2015