Nasal PolypsPhase 3NCT01386125
A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604)
A Phase 3 study testing Mometasone Furoate Nasal Spray (MFNS) in people with Nasal Polyps, run by Organon and Co.
Trial summary
This study will evaluate the effectiveness and safety of MFNS in improving nasal congestion/obstruction and in reducing bilateral nasal polyps. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Polyps
- What is being tested?
- Mometasone Furoate Nasal Spray (MFNS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 748 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Feb 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be Chinese
- Must have a diagnosis of bilateral nasal polyps
- Clinically significant nasal congestion/obstruction must be present
- Must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures, or compromise the participant's safety
- Must have negative urine pregnancy test
- Must be using or agree to use a medically accepted method of contraception prior to Screening and during the study
Who cannot join
- Have a history of seasonal allergic rhinitis within the last two years
- Have had sinus or nasal surgery within the past six months
- Have presumed fibrotic nasal polyps
- Have had three or more nasal surgeries
- Have had any surgical procedure that prevents an accurate grading of the polyps
- Complete (or near complete) nasal obstruction
Show all 17Show fewer
- Have acute sinusitis, concurrent nasal infection or have had a nasal infection within two weeks
- Have ongoing rhinitis medicamentosa
- Have Churg Strauss syndrome (vasculitis, asthma, fever, and eosinophilia)
- Have dyskinetic ciliary syndromes, eg, Young's syndrome (sinopulmonary infections and obstructive azoospermia) or Kartagener's syndrome (immobile cilia)
- Have been treated within the last 4 weeks with intranasal steroids
- Have used any investigational drug in the last 30 days
- Have a hypersensitivity to corticosteroids or are allergic to aspirin
- Have an ongoing upper respiratory tract infection or had an upper respiratory tract infection within two weeks
- Have a nasal septal deviation needing corrective surgery
- Have a nasal septal perforation
- Have asthma that required in-patient hospitalization for asthma control within six months, required ventilator support for respiratory failure secondary to their asthma within the last five years, required admission to the hospital for management of airway obstruction on two or more occasions within the past year, or required use of more than 14 days of systemic steroid use in previous six months
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Nasal Polyps (Protocol No. P05604)
This study will evaluate the effectiveness and safety of MFNS in improving nasal congestion/obstruction and in reducing bilateral nasal polyps.
- Conditions
- Nasal Polyps
- Being tested
- Mometasone Furoate Nasal Spray (MFNS), Placebo for MFNS
- Medical subject headings
- Nasal Polyps
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
MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks
Placebo for MFNSDrug
Two sprays in each nostril BID for up to 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Experimental | Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks Receives: Drug: Mometasone Furoate Nasal Spray (MFNS) |
| Placebo | Placebo comparator | Participants receive matching placebo nasal spray BID for 16 weeks Receives: Drug: Placebo for MFNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Congestion/Obstruction Score
At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline.
Measured: Baseline and Weeks 1-4
Change From Baseline in Total Polyp Size Score
An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline.
Measured: Baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2013
- Study completionFeb 2013
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 Nasal PolypsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 748 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386125
- Sponsor's protocol ID
- P05604
- Status last verified
- Feb 2022
- First submitted
- 9 Jun 2011
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zhou B, He G, Liang J, Cheng L, Mehta A, Liu S, Yu W, Wang Z, Han D. Mometasone furoate nasal spray in the treatment of nasal polyposis in Chinese patients: a double-blind, randomized, placebo-controlled trial. Int Forum Allergy Rhinol. 2016 Jan;6(1):88-94. doi: 10.1002/alr.21650. Epub 2015 Nov 17.
PubMed 26575524
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Nasal Polyps (Protocol No. P05604)
- ClinicalTrials.gov ID
- NCT01386125
- Acronym / sponsor ID
- P05604
- Conditions
- Nasal Polyps
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 748 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Posted 19 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness and safety of MFNS in improving nasal congestion/obstruction and in reducing bilateral nasal polyps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Experimental | Drug: Mometasone Furoate Nasal Spray (MFNS)Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks |
| Placebo | Placebo comparator | Drug: Placebo for MFNSParticipants receive matching placebo nasal spray BID for 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be Chinese
- Must have a diagnosis of bilateral nasal polyps
- Clinically significant nasal congestion/obstruction must be present
- Must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures, or compromise the participant's safety
- Must have negative urine pregnancy test
Key exclusion criteria (17 listed)
- Have a history of seasonal allergic rhinitis within the last two years
- Have had sinus or nasal surgery within the past six months
- Have presumed fibrotic nasal polyps
- Have had three or more nasal surgeries
- Have had any surgical procedure that prevents an accurate grading of the polyps
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)MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks | Drug | Mometasone Furoate Nasal Spray (MFNS) |
| Placebo for MFNSTwo sprays in each nostril BID for up to 16 weeks | Drug | Placebo |
Primary outcome
Change From Baseline in Congestion/Obstruction Score
Time frame: Baseline and Weeks 1-4
At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline.
Change From Baseline in Total Polyp Size Score
Time frame: Baseline and Week 16
An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26575524Zhou B, He G, Liang J, Cheng L, Mehta A, Liu S, Yu W, Wang Z, Han D. Mometasone furoate nasal spray in the treatment of nasal polyposis in Chinese patients: a double-blind, randomized, placebo-controlled trial. Int Forum Allergy Rhinol. 2016 Jan;6(1):88-94. doi: 10.1002/alr.21650. Epub 2015 Nov 17.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mometasone Furoate Nasal Spray (MFNS) in people with Nasal Polyps, 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 6 inclusion and 17 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 21 May 2024. 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 Dec 2013). 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 Congestion/Obstruction Score (time frame: Baseline and Weeks 1-4). The study lists 2 primary outcomes in all. 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 NCT01386125, 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 21 May 2024.