Nasal Polyps
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years old. Safety will be the primary focus of this study.
Interventions
100 mcg nasal spray
DRUGPlacebo nasal spray
One spray of placebo nasal spray in each nostril once daily for 4 months.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* A subject must be 6 to \<18 years of age, of either sex, and of any race. * A subject must have a diagnosis of bilateral nasal polyps. * A subject must have a minimum nasal congestion/obstruction * An asthmatic subject may be included. * A subject's clinical laboratory tests (hematology, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. * The subject and parent/guardian must be willing to give written informed consent, and the subject must be able to adhere to dose and visit schedules. * A female subject of child-bearing potential who is sexually active must have been using a medically accepted method of contraception prior to Screening and must continue using it while receiving protocol-specified medication. If a pre-menarche female subject begins menstruating during the study, a serum pregnancy test must be done at the next visit
Exclusion criteria
* A subject with antrochoanal polyps. * A subject with cystic fibrosis. * A subject with acute sinusitis, concurrent upper respiratory tract infection, or who had an upper respiratory tract infection within 2 weeks prior to the Screening Visit. * A subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. * A subject who is immunocompromised. * A subject with ongoing rhinitis medicamentosa. * A subject with Churg Strauss syndrome. * A subject with dyskinetic ciliary syndromes, eg, Young's syndrome (sinopulmonary infections and obstructive azoospermia) or Kartagener's syndrome (immotile cilia). * A subject with any clinically significant pretreatment laboratory, vital sign, or ECG abnormality. * A subject with allergy/sensitivity to aspirin, corticosteroids, or study drug or its excipients. * A subject who has not observed the medication washout times outlined in the protocol prior to the Screening Visit. * A female subject who is breast-feeding, pregnant, or intends to become pregnant. * A subject who has used any investigational drug within 30 days of Screening. * A subject who is part of the staff personnel directly involved with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline 24-hour Urinary Free Cortisol Level | Baseline to Endpoint | The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to \<18 years of age. Primary safety was to be assessed by determining the subject's 24-hour urinary free cortisol level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine | Baseline to Endpoint | The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID) | 51 |
| MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD) | 50 |
| Pooled Placebo All placebo groups were combined | 26 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Non-compliance with protocol | 0 | 0 | 1 |
| Overall Study | Treatment Failure | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years | MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years | Pooled Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 9.6 years STANDARD_DEVIATION 1.4 | 14.4 years STANDARD_DEVIATION 1.8 | 12.7 years STANDARD_DEVIATION 3.2 | 12.7 years STANDARD_DEVIATION 2.9 |
| Age, Customized 12 to < 18 years | 33 participants | 32 participants | 16 participants | 81 participants |
| Age, Customized 6 to < 12 years | 18 participants | 18 participants | 10 participants | 46 participants |
| Sex: Female, Male Female | 20 Participants | 22 Participants | 12 Participants | 54 Participants |
| Sex: Female, Male Male | 31 Participants | 28 Participants | 14 Participants | 73 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 | 24 / 50 | 23 / 51 | 13 / 26 |
| serious Total, serious adverse events | 0 / 50 | 0 / 51 | 0 / 26 |
Outcome results
Primary
Change From Baseline 24-hour Urinary Free Cortisol Level
The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to \<18 years of age. Primary safety was to be assessed by determining the subject's 24-hour urinary free cortisol level.
Time frame: Baseline to Endpoint
Population: Not all participants that were randomized had both a baseline and an endpoint urine sample. Only participants with both were included in the participants analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years | Change From Baseline 24-hour Urinary Free Cortisol Level | Baseline | 49.5 mcg/hour | Standard Deviation 32.4 |
| MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years | Change From Baseline 24-hour Urinary Free Cortisol Level | Change from Baseline to Endpoint | 1.5 mcg/hour | Standard Deviation 42.9 |
| MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years | Change From Baseline 24-hour Urinary Free Cortisol Level | Baseline | 39.6 mcg/hour | Standard Deviation 32.4 |
| MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years | Change From Baseline 24-hour Urinary Free Cortisol Level | Change from Baseline to Endpoint | 11.6 mcg/hour | Standard Deviation 42.9 |
| Pooled Placebo | Change From Baseline 24-hour Urinary Free Cortisol Level | Baseline | 49.8 mcg/hour | Standard Deviation 32.4 |
| Pooled Placebo | Change From Baseline 24-hour Urinary Free Cortisol Level | Change from Baseline to Endpoint | -2.1 mcg/hour | Standard Deviation 42.9 |
Comparison: Pairwise comparison p-values were based on a two-way ANOVA for the change from baslinep-value: 0.258ANOVA
Comparison: Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.p-value: 0.735ANOVA
Comparison: Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.p-value: 0.194ANOVA
Secondary
Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine
The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine).
Time frame: Baseline to Endpoint
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years | Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine | Baseline | 6.7 mcg/hour | Standard Deviation 4.5 |
| MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years | Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine | Baseline to Endpoint | 0.0 mcg/hour | Standard Deviation 4.9 |
| MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years | Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine | Baseline | 5.3 mcg/hour | Standard Deviation 4.5 |
| MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years | Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine | Baseline to Endpoint | 1.0 mcg/hour | Standard Deviation 4.9 |
| Pooled Placebo | Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine | Baseline | 7.6 mcg/hour | Standard Deviation 4.5 |
| Pooled Placebo | Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine | Baseline to Endpoint | -0.6 mcg/hour | Standard Deviation 4.9 |
Comparison: Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpointp-value: 0.361ANOVA
Comparison: Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.p-value: 0.603ANOVA
Comparison: Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.p-value: 0.193ANOVA