SinusitisPhase 3NCT00423176
The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3)
A Phase 3 study testing MFNS and antibiotic in people with Sinusitis, run by Organon and Co.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone furoate nasal spray), when used together with an antibiotic, for the relief of symptoms associated with acute bacterial sinusitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Sinusitis
- What is being tested?
- MFNS and antibiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 237 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Jun 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
- Must be 12 years of age and older, of either sex, and of any race.
- Must weigh at least 40 kg (88 lb).
- Must be willing to give written informed consent and be able to adhere to dose and visit schedules.
- Must have a clinical diagnosis of acute bacterial sinusitis.
- Must be symptomatic at the Screening and Baseline Visits on the basis of subject assessments of major symptoms score.
- Must have radiographic evidence of sinusitis on CT scans taken at Screening.
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- Must be in general good health and free of any clinically significant disease (other than sinusitis) that would interfere with the study schedule or procedures, or compromise the subject's safety.
- A subject's clinical laboratory tests (hematology, blood chemistry, and urinalysis), vital signs, and electrocardiogram (ECG) recordings must be within normal limits or clinically acceptable to the investigator/qualified designee. Any test results that are questionable should be referred to the sponsor.
- A female subject of child-bearing potential must have a negative serum pregnancy (beta-hCG) test at Screening. She must agree to use a medically accepted method of contraception throughout the entire study period. Postmenopausal women will be exempted from the use of contraception during the study. Documented absence of menses for at least 1 year will indicate that a female is postmenopausal. If a pre-menarche female subject begins menstruating during the study, a serum pregnancy test must be done at the next visit. A female subject of child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the study.
Who cannot join
- A subject with moderate to severe persistent asthma that requires daily treatment with inhaled steroids, or an exacerbation of asthma within the past 30 days.
- A history of chronic sinusitis (symptoms lasting greater than 3 months) or having undergone sinus or nasal surgery for chronic sinusitis or nasal polyps.
- A history of symptomatic seasonal allergic rhinitis and who, during the study period, is living in or traveling to locations where the allergen to which he/she is allergic is present.
- Subject with glaucoma or a history of posterior subcapsular cataracts.
- Subject with nasal polyps visible upon physical examination, immotile cilia syndrome, immunodeficiency disease, cystic fibrosis, clinically significant cardiovascular (including rheumatic heart disease), pulmonary, renal, hepatic, metabolic, hematological or neurologic disease that in the investigator's judgment might interfere with the evaluation of the therapy, or subjects who are immunocompromised, in renal failure, or on dialysis.
- Subject fails to observe the medication washout times outlined in the protocol prior to Screening.
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- Subject has an allergy to corticosteroids or penicillins.
- Subject has used any investigational drug within 30 days of Screening.
- Subject has a concurrent need for antibiotic therapy other than study drug (amoxicillin/clavulanic acid).
- Subject is anticipating sinus or nasal surgery within the next month.
- Subject has been previously randomized into this study.
- Subject is part of the staff personnel directly involved with the study or is a family member of the investigational study staff involved in the study.
About this study
Official title: Efficacy and Safety of 200mcg BID Mometasone Furoate Nasal Spray (MFNS) Versus Placebo as Adjunctive Treatment to Antibiotics in Relief of Symptoms of Acute Bacterial Sinusitis
The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone furoate nasal spray), when used together with an antibiotic, for the relief of symptoms associated with acute bacterial sinusitis. Efficacy will be based on both subjective (assessment of symptom severity by the patient) and objective measurements (computed tomography [CT] imaging of the sinuses).
- Conditions
- Sinusitis
- Being tested
- MFNS and antibiotic, Matching Placebo nasal spray plus antibiotic
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MFNS and antibioticDrug
Also called Group 1: MFNS + Antibiotic
MFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days
Matching Placebo nasal spray plus antibioticDrug
Also called Group 2
Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days
| Study group | Role | What they receive |
|---|---|---|
| MFNS + Antibiotic | Experimental | Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic. Appropriate antibiotic therapy amoxicillin/clavulanic acid BID. Receives: Drug: MFNS and antibiotic |
| Placebo | Placebo comparator | Matching placebo nasal spray BID for 29 days, plus amoxicillin/clavulanic acid BID Receives: Drug: Matching Placebo nasal spray plus antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29.
The least squares mean decrease from Baseline in AM/PM PRIOR MSS, excluding sinus headache, averaged over Days 1 to 29. PRIOR is the subject's status over the previous 12 hours (reflective). The MSS was defined as the sum of the following subject-evaluated symptoms: facial pain/pressure/tenderness, sinus headache, purulent rhinorrhea, post-nasal drip, and nasal stuffiness/congestion.MSS scores are as follows: 0=none, 1=mild, 2=moderate, 3=severe for each individual symptom.
Measured: 29-day Treatment Period and 2-week no-treatment Follow-up Period.
Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline
A coronal computerized tomography was obtained to visulaize all nasal sinuses and the ostiomeatal complex. Opacification was measured as a percentage of the area of the sinus that was occupied by either fluid or mucosal thickening. The change in percentage of opacification of one maxillary sinus (the one with the highest percentage of opacification) as compared to antibiotic treatment alone. The percentage of opacification was measured and the change from baseline for that percentage was reported.
Measured: 29-day Treatment Period and 2-week no-treatment Follow-up Period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Based on business priorities. Not related to any safety or efficacy issue \& took place before data were unblinded or analyzed
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.
- Other trials for SinusitisStudies 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
- 237 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
- NCT00423176
- Sponsor's protocol ID
- P04824
- Status last verified
- Feb 2022
- First submitted
- 17 Jan 2007
- Last updated
- 20 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 200mcg BID Mometasone Furoate Nasal Spray (MFNS) Versus Placebo as Adjunctive Treatment to Antibiotics in Relief of Symptoms of Acute Bacterial Sinusitis
- ClinicalTrials.gov ID
- NCT00423176
- Acronym / sponsor ID
- P04824
- Conditions
- Sinusitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on business priorities. Not related to any safety or efficacy issue \& took place before data were unblinded or analyzed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Posted 22 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone furoate nasal spray), when used together with an antibiotic, for the relief of symptoms associated with acute bacterial sinusitis. Efficacy will be based on both subjective (assessment of symptom severity by the patient) and objective measurements (computed tomography [CT] imaging of the sinuses).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MFNS + Antibiotic | Experimental | Drug: MFNS and antibioticMometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic. Appropriate antibiotic therapy amoxicillin/clavulanic acid BID. |
| Placebo | Placebo comparator | Drug: Matching Placebo nasal spray plus antibioticMatching placebo nasal spray BID for 29 days, plus amoxicillin/clavulanic acid BID |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Must be 12 years of age and older, of either sex, and of any race.
- Must weigh at least 40 kg (88 lb).
- Must be willing to give written informed consent and be able to adhere to dose and visit schedules.
- Must have a clinical diagnosis of acute bacterial sinusitis.
- Must be symptomatic at the Screening and Baseline Visits on the basis of subject assessments of major symptoms score.
Key exclusion criteria (12 listed)
- A subject with moderate to severe persistent asthma that requires daily treatment with inhaled steroids, or an exacerbation of asthma within the past 30 days.
- A history of chronic sinusitis (symptoms lasting greater than 3 months) or having undergone sinus or nasal surgery for chronic sinusitis or nasal polyps.
- A history of symptomatic seasonal allergic rhinitis and who, during the study period, is living in or traveling to locations where the allergen to which he/she is allergic is present.
- Subject with glaucoma or a history of posterior subcapsular cataracts.
- Subject with nasal polyps visible upon physical examination, immotile cilia syndrome, immunodeficiency disease, cystic fibrosis, clinically significant cardiovascular (including rheumatic heart disease), pulmonary, renal, hepatic, metabolic, hematological or neurologic disease that in the investigator's judgment might interfere with the evaluation of the therapy, or subjects who are immunocompromised, in renal failure, or on dialysis.
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 |
|---|---|---|
| MFNS and antibioticAlso: Group 1: MFNS + AntibioticMFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days | Drug | MFNS + Antibiotic |
| Matching Placebo nasal spray plus antibioticAlso: Group 2Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days | Drug | Placebo |
Primary outcome
Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29.
Time frame: 29-day Treatment Period and 2-week no-treatment Follow-up Period.
The least squares mean decrease from Baseline in AM/PM PRIOR MSS, excluding sinus headache, averaged over Days 1 to 29. PRIOR is the subject's status over the previous 12 hours (reflective). The MSS was defined as the sum of the following subject-evaluated symptoms: facial pain/pressure/tenderness, sinus headache, purulent rhinorrhea, post-nasal drip, and nasal stuffiness/congestion.MSS scores are as follows: 0=none, 1=mild, 2=moderate, 3=severe for each individual symptom.
Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline
Time frame: 29-day Treatment Period and 2-week no-treatment Follow-up Period.
A coronal computerized tomography was obtained to visulaize all nasal sinuses and the ostiomeatal complex. Opacification was measured as a percentage of the area of the sinus that was occupied by either fluid or mucosal thickening. The change in percentage of opacification of one maxillary sinus (the one with the highest percentage of opacification) as compared to antibiotic treatment alone. The percentage of opacification was measured and the change from baseline for that percentage was reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 MFNS and antibiotic in people with Sinusitis, 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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 20 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 22 Jun 2010). 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?
Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29. (time frame: 29-day Treatment Period and 2-week no-treatment Follow-up Period.). 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?
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 20 May 2024.