Seasonal Allergic RhinitisPhase 4NCT00491504
This Study Contains an Active Drug Treatment Group With Mometasone Furoate Nasal Spray and a Placebo (Dummy) Treatment Group for Seasonal Allergic Rhinitis (SAR). (Study P05073)(COMPLETED)
A Phase 4 study testing Mometasone Furoate Nasal Spray in people with Seasonal Allergic Rhinitis, run by Organon and Co.
Trial summary
The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting. Evaluation will be based on subjects self-assessed nose symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Mometasone Furoate Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Jul 2007
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate and to adhere to dose and visit schedules
- 18 to 65 years, either sex, any race
- 2-year history of SAR, being symptomatic during the last 2 ragweed seasons
- Skin test positive to short ragweed allergen at screening, or positive within 12 months
- Women must practice adequate contraception: Females of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who are postmenopausal for >1 year (ie, women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study.; Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation)
- Negative pregnancy tests during study
Who cannot join
- Compromised ability to provide informed consent
- Nasal abnormalities, including large nasal polyps, and marked septum deviation that interferes with nasal airflow at screening
- Recent (within the last 2 weeks) or unhealed nasal septum ulcers, nasal surgery, or nasal trauma
- Unstable asthma which cannot be controlled with inhaled short-acting beta-2 agonists
- Diagnosed with sinusitis within the previous 2 weeks
- Is initiating or is currently on advanced immunotherapy
Show all 14Show fewer
- If on immunotherapy (desensitization therapy), the subject must be stable and should not receive an increase in dose during the study. Subjects may not receive desensitization treatment within 24 hours prior to a study visit
- Is currently on or has been on an antihistamine, decongestant (topical or systemic) or a nasal inhaled corticosteroid during the 14 days prior to the first priming visit
- Unable to refrain from regular use of nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids
- Failed the designated washout periods for any of the prohibited medications
- Upper or lower respiratory tract or sinus infection that required antibiotic therapy or a viral upper or lower respiratory infection within 14 days prior to screening
- Is allergic to or has sensitivity to the study drug or its excipients
- Used any investigational product within 30 days before enrollment or any antibodies for asthma or allergic rhinitis in the past 90 days
- Subject has Chronic obstructive pulmonary disease, Alcohol abuse, Rhinitis medicamentosa
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study Using Subjective and Objective Measures to Evaluate the Clinical Efficacy of Mometasone Furoate Nasal Spray (MFNS) Following Initial and Maintenance Dosing in Subjects With Allergen-Induced Seasonal Allergic Rhinitis (SAR) in an Environmental Exposure Chamber (EEC)
The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting. Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will evaluate are: 1) changes in eye symptoms (ocular symptom severity score) after dosing 2) how long MFNS works in relieving the nose (nasal) and eye (ocular) symptoms after 7 daily doses, 3) measurements of nose (nasal) blockage (obstruction), and 4) measurements of the subject's opinion of the study drugs by asking different questions. This study is could last up to 53 days for some subjects.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Mometasone Furoate Nasal Spray, Placebo
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone Furoate Nasal SprayDrug
Also called SCH 032088
Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg)
PlaceboOther
Placebo: 2 sprays in each nostril
| Study group | Role | What they receive |
|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Experimental | MFNS 200 mcg total dose (2 sprays each nostril) Receives: Drug: Mometasone Furoate Nasal Spray |
| Placebo | Placebo comparator | Placebo (2 sprays each nostril) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1
Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea \& itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, \& disturbing some of the time; 3=Severe: sign/symptom very noticeable \& very bothersome most of the time.
Measured: Baseline and 6 hours following initial dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startFeb 2007
- Primary completionJul 2007
- Study completionJul 2007
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 Seasonal 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 310 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
- NCT00491504
- Sponsor's protocol ID
- P05073
- Status last verified
- Feb 2022
- First submitted
- 25 Jun 2007
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Salapatek AM, Patel P, Gopalan G, Varghese ST. Mometasone furoate nasal spray provides early, continuing relief of nasal congestion and improves nasal patency in allergic patients. Am J Rhinol Allergy. 2010 Nov-Dec;24(6):433-8. doi: 10.2500/ajra.2010.24.3548. Epub 2010 Nov 10.
PubMed 21067660
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
- A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study Using Subjective and Objective Measures to Evaluate the Clinical Efficacy of Mometasone Furoate Nasal Spray (MFNS) Following Initial and Maintenance Dosing in Subjects With Allergen-Induced Seasonal Allergic Rhinitis (SAR) in an Environmental Exposure Chamber (EEC)
- ClinicalTrials.gov ID
- NCT00491504
- Acronym / sponsor ID
- P05073
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 26 Jun 2007 (estimated)
- Results
- Posted 5 Apr 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 how well mometasone furoate nasal spray (MFNS) works to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting. Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will evaluate are: 1) changes in eye symptoms (ocular symptom severity score) after dosing 2) how long MFNS works in relieving the nose (nasal) and eye (ocular) symptoms after 7 daily doses, 3) measurements of nose (nasal) blockage (obstruction), and 4) measurements of the subject's opinion of the study drugs by asking different questions. This study is could last up to 53 days for some subjects.
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 SprayMFNS 200 mcg total dose (2 sprays each nostril) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (2 sprays each nostril) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing to participate and to adhere to dose and visit schedules
- 18 to 65 years, either sex, any race
- 2-year history of SAR, being symptomatic during the last 2 ragweed seasons
- Skin test positive to short ragweed allergen at screening, or positive within 12 months
- Women must practice adequate contraception: Females of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who are postmenopausal for >1 year (ie, women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study.; Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation)
Key exclusion criteria (14 listed)
- Compromised ability to provide informed consent
- Nasal abnormalities, including large nasal polyps, and marked septum deviation that interferes with nasal airflow at screening
- Recent (within the last 2 weeks) or unhealed nasal septum ulcers, nasal surgery, or nasal trauma
- Unstable asthma which cannot be controlled with inhaled short-acting beta-2 agonists
- Diagnosed with sinusitis within the previous 2 weeks
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 SprayAlso: SCH 032088Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg) | Drug | Mometasone Furoate Nasal Spray (MFNS) |
| PlaceboPlacebo: 2 sprays in each nostril | Other | Placebo |
Primary outcome
Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1
Time frame: Baseline and 6 hours following initial dosing
Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea \& itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, \& disturbing some of the time; 3=Severe: sign/symptom very noticeable \& very bothersome most of the time.
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 21067660Salapatek AM, Patel P, Gopalan G, Varghese ST. Mometasone furoate nasal spray provides early, continuing relief of nasal congestion and improves nasal patency in allergic patients. Am J Rhinol Allergy. 2010 Nov-Dec;24(6):433-8. doi: 10.2500/ajra.2010.24.3548. Epub 2010 Nov 10.
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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 4 study testing Mometasone Furoate Nasal Spray in people with Seasonal 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 6 inclusion and 14 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 5 Apr 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?
Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1 (time frame: Baseline and 6 hours following initial dosing). 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 NCT00491504, 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.