Allergic RhinitisPhase 4NCT00783237
Onset of Effect of Mometasone Nasal Spray in Induced Allergic Rhinitis (Study P03431)
A Phase 4 study testing Mometasone in people with Allergic Rhinitis, run by Organon and Co.
Trial summary
This was a single-dose study to determine the time it takes for mometasone furoate nasal spray to go in effect, after a single dose of 2 sprays per nostril. Patients who are eligible were exposed to ragweed pollen for 3 hours on one or two occasions. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2003to 21 Feb 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- at least 12 years old,
- had a history of SAR to ragweed pollen for at least one year
- had a positive skin test (prick) to short ragweed allergen.
- if female, had a negative urine pregnancy test (HCG) at the Screening Visit, and prior to treatment on the Treatment Visit
- were non pregnant women of childbearing potential and used a medically acceptable, adequate form of birth control.
Who cannot join
- developed signs or symptoms of bronchospasm, i.e., wheezing, dyspnea, and/or cough, during the priming sessions;
- had any significant medical condition which, in the judgment of the investigator, might interfere with the study or require treatment;
- had an upper respiratory or sinus infection within two weeks prior to treatment;
- had received escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for treatment of rhinitis;
- were female subjects who were pregnant, breast feeding, or premenarchal;
- could not adhere to concomitant medication prohibitions;
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- had a known potential for hypersensitivity, allergy, or idiosyncratic reaction to mometasone furoate nasal spray;
- had asthma that requires systemic or inhaled corticosteroid treatment;
- had large nasal polyps, marked septum deviations, or any other nasal structural abnormality that significantly interferes with nasal airflow;
- had rhinitis medicamentosa;
- had any relevant abnormal vital sign due to an unknown underlying disease and considered by the investigator and Sponsor Monitor to contraindicate study participation.
About this study
Official title: Onset of Action of Mometasone Furoate Nasal Spray vs. Placebo in Induced Allergic Rhinitis
This was a single-dose study to determine the time it takes for mometasone furoate nasal spray to go in effect, after a single dose of 2 sprays per nostril. Patients who are eligible were exposed to ragweed pollen for 3 hours on one or two occasions. Patients who experienced adequate symptoms during the pollen exposure phase came back for a Treatment Phase visit. During the Treatment Phase visit, patients were exposed to ragweed pollen for 2 hours and then received either mometasone or placebo nasal spray. Symptom evaluations began on the patients every hour for the next 11 hours.
- Conditions
- Allergic Rhinitis
- Being tested
- Mometasone, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MometasoneDrug
Also called Nasonex, SCH 032088
Mometasone Furoate Nasal Spray, single dose of 200 mcg (2 sprays per nostril)
PlaceboDrug
Placebo nasal spray, single dose of 2 sprays per nostril
| Study group | Role | What they receive |
|---|---|---|
| Mometasone Furoate Nasal Spray | Experimental | Not described Receives: Drug: Mometasone |
| Placebo Nasal Spray | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS)
Measured: On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours
Secondary outcomes (1)
Nasal and Non-Nasal symptoms, Total Nasal and Total Non-Nasal symptoms, Total Symptom Score, Global Therapeutic Response
Measured: On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study start1 Dec 2003
- Primary completion21 Feb 2004
- Study completion21 Feb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 340 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
- NCT00783237
- Sponsor's protocol ID
- P03431
- Status last verified
- Feb 2022
- First submitted
- 30 Oct 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Berger WE, Nayak AS, Staudinger HW. Mometasone furoate improves congestion in patients with moderate-to-severe seasonal allergic rhinitis. Ann Pharmacother. 2005 Dec;39(12):1984-9. doi: 10.1345/aph.1G202. Epub 2005 Nov 8.
PubMed 16278257
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset of Action of Mometasone Furoate Nasal Spray vs. Placebo in Induced Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00783237
- Acronym / sponsor ID
- P03431
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2003 (actual)
- Primary completion
- 21 Feb 2004 (actual)
- Study completion
- 21 Feb 2004 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a single-dose study to determine the time it takes for mometasone furoate nasal spray to go in effect, after a single dose of 2 sprays per nostril. Patients who are eligible were exposed to ragweed pollen for 3 hours on one or two occasions. Patients who experienced adequate symptoms during the pollen exposure phase came back for a Treatment Phase visit. During the Treatment Phase visit, patients were exposed to ragweed pollen for 2 hours and then received either mometasone or placebo nasal spray. Symptom evaluations began on the patients every hour for the next 11 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mometasone Furoate Nasal Spray | Experimental | Drug: Mometasone |
| Placebo Nasal Spray | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- at least 12 years old,
- had a history of SAR to ragweed pollen for at least one year
- had a positive skin test (prick) to short ragweed allergen.
- if female, had a negative urine pregnancy test (HCG) at the Screening Visit, and prior to treatment on the Treatment Visit
- were non pregnant women of childbearing potential and used a medically acceptable, adequate form of birth control.
Key exclusion criteria (11 listed)
- developed signs or symptoms of bronchospasm, i.e., wheezing, dyspnea, and/or cough, during the priming sessions;
- had any significant medical condition which, in the judgment of the investigator, might interfere with the study or require treatment;
- had an upper respiratory or sinus infection within two weeks prior to treatment;
- had received escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for treatment of rhinitis;
- were female subjects who were pregnant, breast feeding, or premenarchal;
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 |
|---|---|---|
| MometasoneAlso: Nasonex, SCH 032088Mometasone Furoate Nasal Spray, single dose of 200 mcg (2 sprays per nostril) | Drug | Mometasone Furoate Nasal Spray |
| PlaceboPlacebo nasal spray, single dose of 2 sprays per nostril | Drug | Placebo Nasal Spray |
Primary outcome
Total Nasal Symptom Score (TNSS)
Time frame: On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours
1 secondary outcome
Nasal and Non-Nasal symptoms, Total Nasal and Total Non-Nasal symptoms, Total Symptom Score, Global Therapeutic Response
Time frame: On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Results publication: PubMed 16278257Berger WE, Nayak AS, Staudinger HW. Mometasone furoate improves congestion in patients with moderate-to-severe seasonal allergic rhinitis. Ann Pharmacother. 2005 Dec;39(12):1984-9. doi: 10.1345/aph.1G202. Epub 2005 Nov 8.
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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 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 5 inclusion and 11 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 15 Aug 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Nasal Symptom Score (TNSS) (time frame: On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours). 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 NCT00783237, 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 15 Aug 2024.