Rhinitis, Allergic, SeasonalPhase 3NCT03861559
Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184)
A Phase 3 study testing mometasone furoate nasal spray in people with Rhinitis, Allergic, Seasonal, run by Organon and Co.
Trial summary
This study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo for 14 days. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- mometasone furoate nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 1994to 7 Jul 1994
- 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
- Has a 2-year history of seasonal allergic rhinitis
- Has a positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
- Is in good health and free of any unstable, clinically-significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis
Who cannot join
- Women who are pregnant or breastfeeding
- Women of childbearing potential who are not using an acceptable form of birth control
- Has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn, or nedocromil
- Has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study, or required treatment which might interfere with the study
- Is on immunotherapy with the exception of maintenance therapy
- Has a clinically significant upper respiratory or sinus infection
Show all 12Show fewer
- Has used an investigational drug within the previous 30 days
- Has nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
- Has a history of multiple drug allergies or an allergy to antihistamines or corticoids
- Has dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
- Has rhinitis medicamentosa
- Is using of any chronic medication which could affect the course of seasonal allergic rhinitis
About this study
Official title: Onset of Action of Mometasone Furoate (SCH 32088) Nasal Spray 50 mcg/Spray vs Placebo in Seasonal Allergic Rhinitis (Study No. C93-184).
This study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo for 14 days.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- mometasone furoate nasal spray, placebo nasal spray
- 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 NASONEX®, MK-0887, SCH 032088
intranasal administration
placebo nasal sprayDrug
intranasal administration
| Study group | Role | What they receive |
|---|---|---|
| mometasone furoate nasal spray | Experimental | Participants administered mometasone furoate nasal spray 200 mcg once daily (QD), as two 50 mcg sprays per nostril, for 14 consecutive days. Receives: Drug: mometasone furoate nasal spray |
| placebo nasal spray | Placebo comparator | Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days. Receives: Drug: placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Time to Onset of Nasal Symptom Relief as Assessed by Participant Diary Responses
Time to onset of relief of nasal stuffiness/congestion, rhinorrhea, nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears or palate was assessed by the participant using diary response data in the morning and night for the first 3 days of treatment. The participants were asked to rate their relief on the following scale: 1=complete, 2=marked, 3=moderate, 4=slight, and 5=none. If a participant recorded a degree of relief that was at least moderate (3 or below), they answered the question, "When did you first experience noticeable relief?" and noted the date and time. The data were analyzed using a log ranked test and with a Kaplan-Meier estimate. Any participant who did not experience at least moderate relief by the end of 72 hours was considered censored at that time in the analysis. Time to onset of relief is presented in hours.
Measured: From the start of treatment until onset of symptom relief (up to Day 4)
Secondary outcomes (16)
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) Averaged Over 15 Days of Treatment, as Assessed by Participant
CFB, averaged over study days 1-15, was calculated for TNSS assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries using the scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. A decrease in symptom severity is reflected by a negative CFB.
Percent CFB was calculated as the difference between the baseline and 15-day average scores divided by baseline score multiplied by 100. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score was an average of the three AM and three PM scores preceding treatment.
Measured: Baseline (3 days preceding treatment) through Day 15 (averaged over 15 days)
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 4 as Assessed by Investigator
CFB on study Day 4 was calculated for TNSS assessed by investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on study Day 4, on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.
Measured: Baseline (Day 1) and Day 4
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator
CFB on study Day 8 was calculated for TNSS assessed by investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.
Measured: Baseline (Day 1) and Day 8
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 15 as Assessed by Investigator
CFB at Day 15 was calculated for TNSS assessed by the investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and endpoint scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant.
Measured: Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.
Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Investigator
CFB on study Day 4 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.
Measured: Baseline (Day 1) and Day 4
Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Investigator
CFB on study Day 8 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.
Measured: Baseline (Day 1) and Day 8
Change From Baseline in Overall Disease Condition Score at Day 15 as Assessed by Investigator
CFB on study Day 15 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 15 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant.
Measured: Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.
Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Participant
CFB on study Day 4 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant scored their overall condition on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.
Measured: Baseline (Day 1) and Day 4
Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Participant
CFB on study Day 8 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant scored their overall condition on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.
Measured: Baseline (Day 1) and Day 8
Change From Baseline (CFB) in Overall Disease Condition Score at Day 15 as Assessed by Participant
CFB on study Day 15 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant scored their overall condition on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 15 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.
Measured: Baseline (Day 1) and Day 15
Therapeutic Response to Treatment at Day 4 as Assessed by Investigator
Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 4. Treatment response was evaluated by the investigator using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.
Measured: Day 4
Therapeutic Response to Treatment at Day 8 as Assessed by Investigator
Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 8. Treatment response was evaluated by the investigator using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.
Measured: Day 8
Therapeutic Response to Treatment at Day 15 as Assessed by Investigator
Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 15. Treatment response was evaluated by the investigator using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant.
Measured: Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.
Therapeutic Response to Treatment at Day 4 as Assessed by Participant
Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 4. Treatment response was evaluated by the participant using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.
Measured: Day 4
Therapeutic Response to Treatment at Day 8 as Assessed by Participant
Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 8. Treatment response was evaluated by the participant using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.
Measured: Day 8
Therapeutic Response to Treatment at Day 15 as Assessed by Participant
Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 15. Treatment response was evaluated by the participant using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start30 Mar 1994
- Primary completion27 Jun 1994
- Study completion7 Jul 1994
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 Rhinitis, Allergic, SeasonalStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 201 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
- NCT03861559
- Sponsor's protocol ID
- C93-184
- Other IDs
- C93-184
- Status last verified
- Feb 2022
- First submitted
- 1 Mar 2019
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Onset of Action of Mometasone Furoate (SCH 32088) Nasal Spray 50 mcg/Spray vs Placebo in Seasonal Allergic Rhinitis (Study No. C93-184).
- ClinicalTrials.gov ID
- NCT03861559
- Acronym / sponsor ID
- C93-184
- Conditions
- Rhinitis, Allergic, Seasonal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 1994 (actual)
- Primary completion
- 27 Jun 1994 (actual)
- Study completion
- 7 Jul 1994 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Posted 20 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo for 14 days.
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 furoate nasal sprayParticipants administered mometasone furoate nasal spray 200 mcg once daily (QD), as two 50 mcg sprays per nostril, for 14 consecutive days. |
| placebo nasal spray | Placebo comparator | Drug: placebo nasal sprayParticipants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Has a 2-year history of seasonal allergic rhinitis
- Has a positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
- Is in good health and free of any unstable, clinically-significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis
Key exclusion criteria (12 listed)
- Women who are pregnant or breastfeeding
- Women of childbearing potential who are not using an acceptable form of birth control
- Has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn, or nedocromil
- Has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study, or required treatment which might interfere with the study
- Is on immunotherapy with the exception of maintenance therapy
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: NASONEX®, MK-0887, SCH 032088intranasal administration | Drug | mometasone furoate nasal spray |
| placebo nasal sprayintranasal administration | Drug | placebo nasal spray |
Primary outcome
Median Time to Onset of Nasal Symptom Relief as Assessed by Participant Diary Responses
Time frame: From the start of treatment until onset of symptom relief (up to Day 4)
Time to onset of relief of nasal stuffiness/congestion, rhinorrhea, nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears or palate was assessed by the participant using diary response data in the morning and night for the first 3 days of treatment. The participants were asked to rate their relief on the following scale: 1=complete, 2=marked, 3=moderate, 4=slight, and 5=none. If a participant recorded a degree of relief that was at least moderate (3 or below), they answered the question, "When did you first experience noticeable relief?" and noted the date and time. The data were analyzed using a log ranked test and with a Kaplan-Meier estimate. Any participant who did not experience at least moderate relief by the end of 72 hours was considered censored at that time in the analysis. Time to onset of relief is presented in hours.
16 secondary outcomes
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) Averaged Over 15 Days of Treatment, as Assessed by Participant
Time frame: Baseline (3 days preceding treatment) through Day 15 (averaged over 15 days)
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 4 as Assessed by Investigator
Time frame: Baseline (Day 1) and Day 4
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator
Time frame: Baseline (Day 1) and Day 8
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 15 as Assessed by Investigator
Time frame: Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.
Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Investigator
Time frame: Baseline (Day 1) and Day 4
Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Investigator
Time frame: Baseline (Day 1) and Day 8
Change From Baseline in Overall Disease Condition Score at Day 15 as Assessed by Investigator
Time frame: Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.
Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Participant
Time frame: Baseline (Day 1) and Day 4
Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Participant
Time frame: Baseline (Day 1) and Day 8
Change From Baseline (CFB) in Overall Disease Condition Score at Day 15 as Assessed by Participant
Time frame: Baseline (Day 1) and Day 15
Therapeutic Response to Treatment at Day 4 as Assessed by Investigator
Time frame: Day 4
Therapeutic Response to Treatment at Day 8 as Assessed by Investigator
Time frame: Day 8
Therapeutic Response to Treatment at Day 15 as Assessed by Investigator
Time frame: Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.
Therapeutic Response to Treatment at Day 4 as Assessed by Participant
Time frame: Day 4
Therapeutic Response to Treatment at Day 8 as Assessed by Participant
Time frame: Day 8
Therapeutic Response to Treatment at Day 15 as Assessed by Participant
Time frame: Day 15
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.
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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 in people with Rhinitis, Allergic, Seasonal, 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 3 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: 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 20 Sep 2019). 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?
Median Time to Onset of Nasal Symptom Relief as Assessed by Participant Diary Responses (time frame: From the start of treatment until onset of symptom relief (up to Day 4)). 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 9 Feb 2022.