Seasonal Allergic RhinitisPhase 1NCT05887843
Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis
A Phase 1 study testing Mometasone + Azelastine, Mometasone Furoate and Azelastine Hydrochloride in people with Seasonal Allergic Rhinitis, run by Sandoz at 1 site in Canada.
Trial summary
This study will compare the PK parameters of the combination test formulation to monotherapy reference products (mometasone furoate and azelastine hydrochloride) in adolescents and young adult patients with seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Mometasone + Azelastine, Mometasone Furoate and Azelastine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jun 2023to 8 Sep 2023
- Phase
- Phase 1
- 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 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Non-smoking, adolescent or young adult male and female subjects with seasonal allergic rhinitis.
- Willing to use acceptable, effective methods of contraception.
- Be informed of the nature of the study and give written consent (adults) / assent and consent by legal guardian(s)/parent(s) (adolescents) prior to any study procedure.
Who cannot join
- Known history or presence of clinically significant disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Known history or presence of hypersensitivity or idiosyncratic reaction to mometasone, azelastine, or any other drug substances with similar activity.
- Unable to tolerate direct venipuncture.
- Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- Positive test result for urine drugs of abuse or urine cotinine.
- Presence of nostril or septum piercing.
Show all 14Show fewer
- Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
- Females who are pregnant, breast-feeding, or have used hormonal contraceptives within 21 days (oral and transdermal) or 6 months (implanted, injected, intravaginal, or intrauterine) prior to drug administration.
- Donation or loss of whole blood (including clinical trials) within 30 days prior to drug administration (or 56 days for ≥500 mL).
- Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
- Received any type of live vaccine within 30 days prior to drug administration.
- Use of medication within 30 days prior to drug administration.
- On a special diet within 30 days prior to drug administration.
- Have had a tattoo or body piercing within 30 days prior to drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-Dose, Three-way Crossover Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents (12 to 17 Years of Age) and Young Adults (18 to 24 Years of Age) With Seasonal Allergic Rhinitis
This study will compare the PK parameters of the combination test formulation to monotherapy reference products (mometasone furoate and azelastine hydrochloride) in adolescents and young adult patients with seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Mometasone + Azelastine, Mometasone Furoate, Azelastine Hydrochloride
- 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 + AzelastineDrug
Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril
Mometasone FuroateDrug
Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril
Azelastine HydrochlorideDrug
Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril
| Study group | Role | What they receive |
|---|---|---|
| Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride | Experimental | Not described Receives: Drug: Mometasone + Azelastine; Drug: Mometasone Furoate; Drug: Azelastine Hydrochloride |
| Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine | Experimental | Not described Receives: Drug: Mometasone + Azelastine; Drug: Mometasone Furoate; Drug: Azelastine Hydrochloride |
| Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate | Experimental | Not described Receives: Drug: Mometasone + Azelastine; Drug: Mometasone Furoate; Drug: Azelastine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear up/log down variant of the trapezoidal method.
Measured: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
AUCinf
The area under the analyte concentration versus time curve from time zero to infinity. AUCinf = AUCt + Ct/Kel, where Ct is the last measurable analyte concentration.
Measured: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Cmax
Maximum measured analyte concentration over the sampling period.
Measured: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Tmax
Time of the maximum measured analyte concentration over the sampling period.
Measured: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Kel
The apparent first-order elimination rate constant
Measured: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Thalf
The apparent elimination half-life
Measured: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start8 Jun 2023
- Primary completion8 Sep 2023
- Study completion8 Sep 2023
Why it stopped: Business decision (no safety concerns).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887843
- Sponsor's protocol ID
- SAN-0791
- Other IDs
- 2023-000362-34, 2023
- Status last verified
- Sep 2023
- First submitted
- 24 May 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-Dose, Three-way Crossover Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents (12 to 17 Years of Age) and Young Adults (18 to 24 Years of Age) With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT05887843
- Acronym / sponsor ID
- SAN-0791
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision (no safety concerns).
- Enrolment
- 38 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 8 Sep 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 5 Jun 2023 (actual)
- 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 study will compare the PK parameters of the combination test formulation to monotherapy reference products (mometasone furoate and azelastine hydrochloride) in adolescents and young adult patients with seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride | Experimental | Drug: Mometasone + Azelastine, Drug: Mometasone Furoate, Drug: Azelastine Hydrochloride |
| Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine | Experimental | Drug: Mometasone + Azelastine, Drug: Mometasone Furoate, Drug: Azelastine Hydrochloride |
| Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate | Experimental | Drug: Mometasone + Azelastine, Drug: Mometasone Furoate, Drug: Azelastine Hydrochloride |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Non-smoking, adolescent or young adult male and female subjects with seasonal allergic rhinitis.
- Willing to use acceptable, effective methods of contraception.
- Be informed of the nature of the study and give written consent (adults) / assent and consent by legal guardian(s)/parent(s) (adolescents) prior to any study procedure.
Key exclusion criteria (14 listed)
- Known history or presence of clinically significant disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Known history or presence of hypersensitivity or idiosyncratic reaction to mometasone, azelastine, or any other drug substances with similar activity.
- Unable to tolerate direct venipuncture.
- Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- Positive test result for urine drugs of abuse or urine cotinine.
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 + AzelastineMometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril | Drug | Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate, Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride, Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine |
| Mometasone FuroateMometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril | Drug | Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate, Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride, Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine |
| Azelastine HydrochlorideAzelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril | Drug | Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate, Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride, Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine |
Primary outcome
AUCt
Time frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear up/log down variant of the trapezoidal method.
AUCinf
Time frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
The area under the analyte concentration versus time curve from time zero to infinity. AUCinf = AUCt + Ct/Kel, where Ct is the last measurable analyte concentration.
Cmax
Time frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Maximum measured analyte concentration over the sampling period.
Tmax
Time frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Time of the maximum measured analyte concentration over the sampling period.
Kel
Time frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
The apparent first-order elimination rate constant
Thalf
Time frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
The apparent elimination half-life
Results and safety
The study was stopped early (reason given: Business decision (no safety concerns).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mometasone + Azelastine, Mometasone Furoate and Azelastine Hydrochloride in people with Seasonal Allergic Rhinitis, run by Sandoz at 1 site in Canada.
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 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: stopped early, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Business decision (no safety concerns).). Results are not available in the source record.
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?
AUCt (time frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose). The study lists 6 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 28 Sep 2023.