Allergic RhinitisPhase 3NCT00728416
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)
A Phase 3 study testing Mometasone furoate nasal spray (MFNS) in people with Allergic Rhinitis, run by Organon and Co.
Trial summary
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Mometasone furoate nasal spray (MFNS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A subject must be 12 years of age or older, of either sex, and of any race.
- A subject must have at least a 2-year history of SAR which exacerbates during the study season.
- A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
- A subject must be clinically symptomatic at the Screening and Baseline Visits.
Who cannot join
- A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
- A subject who has 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 has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
- A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
- A subject who is participating in any other clinical study.
- A subject who is part of the staff personnel directly involved with this study.
- A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
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- A female subject who is breast-feeding, pregnant, or intends to become pregnant.
- A subject previously randomized into this study.
- A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.
About this study
Official title: Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.
- Conditions
- Allergic Rhinitis
- Being tested
- Mometasone furoate nasal spray (MFNS), Matching placebo nasal spray
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone furoate nasal spray (MFNS)Drug
Also called MK-0887, Nasonex Nasal Spray
MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days
Matching placebo nasal sprayDrug
Also called Placebo
Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Mometasone furoate nasal spray 200 mcg QD (once per day) Receives: Drug: Mometasone furoate nasal spray (MFNS) |
| Arm 2 | Placebo comparator | Matching placebo nasal spray Receives: Drug: Matching placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.
Measured: 15 days of treatment
Secondary outcomes (1)
Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.
Measured: 15 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728416
- Sponsor's protocol ID
- P05583
- Other IDs
- MK-0887-160
- Status last verified
- Feb 2022
- First submitted
- 31 Jul 2008
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Meltzer EO, Shekar T, Teper AA. Mometasone furoate nasal spray for moderate-to-severe nasal congestion in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 Mar-Apr;32(2):159-67. doi: 10.2500/aap.2011.32.3424.
PubMed 21439168
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)
- ClinicalTrials.gov ID
- NCT00728416
- Acronym / sponsor ID
- P05583
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Aug 2008 (estimated)
- Results
- Posted 19 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Mometasone furoate nasal spray (MFNS)Mometasone furoate nasal spray 200 mcg QD (once per day) |
| Arm 2 | Placebo comparator | Drug: Matching placebo nasal sprayMatching placebo nasal spray |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- A subject must be 12 years of age or older, of either sex, and of any race.
- A subject must have at least a 2-year history of SAR which exacerbates during the study season.
- A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
- A subject must be clinically symptomatic at the Screening and Baseline Visits.
Key exclusion criteria (9 listed)
- A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
- A subject who has 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 has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
- A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
- A subject who is participating in any other clinical study.
- A subject who is part of the staff personnel directly involved with this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mometasone furoate nasal spray (MFNS)Also: MK-0887, Nasonex Nasal SprayMFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days | Drug | Arm 1 |
| Matching placebo nasal sprayAlso: PlaceboMatching placebo nasal spray: 2 sprays in each nostril once daily for 15 days | Drug | Arm 2 |
Primary outcome
Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days
Time frame: 15 days of treatment
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.
1 secondary outcome
Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
Time frame: 15 days of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21439168Meltzer EO, Shekar T, Teper AA. Mometasone furoate nasal spray for moderate-to-severe nasal congestion in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 Mar-Apr;32(2):159-67. doi: 10.2500/aap.2011.32.3424.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mometasone furoate nasal spray (MFNS) in people with Allergic Rhinitis, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days (time frame: 15 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00728416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.