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

September 26, 2023 updated by: Sandoz

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Sandoz Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Non-smoking, adolescent or young adult male and female subjects with seasonal allergic rhinitis.
  2. Willing to use acceptable, effective methods of contraception.
  3. 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.

Exclusion Criteria:

  1. 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.
  2. Known history or presence of hypersensitivity or idiosyncratic reaction to mometasone, azelastine, or any other drug substances with similar activity.
  3. Unable to tolerate direct venipuncture.
  4. Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
  5. Positive test result for urine drugs of abuse or urine cotinine.
  6. Presence of nostril or septum piercing.
  7. Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
  8. 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.
  9. Donation or loss of whole blood (including clinical trials) within 30 days prior to drug administration (or 56 days for ≥500 mL).
  10. 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.
  11. Received any type of live vaccine within 30 days prior to drug administration.
  12. Use of medication within 30 days prior to drug administration.
  13. On a special diet within 30 days prior to drug administration.
  14. Have had a tattoo or body piercing within 30 days prior to drug administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride
Drug: Mometasone + Azelastine
Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril
Drug: Mometasone Furoate
Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril
Drug: Azelastine Hydrochloride
Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril
Experimental: Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine
Drug: Mometasone + Azelastine
Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril
Drug: Mometasone Furoate
Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril
Drug: Azelastine Hydrochloride
Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril
Experimental: Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate
Drug: Mometasone + Azelastine
Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril
Drug: Mometasone Furoate
Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril
Drug: Azelastine Hydrochloride
Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
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.
From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
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.
From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
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.
From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
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
From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Thalf
Time Frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
The apparent elimination half-life
From time 0 hours (prior to dosing), up to 48 or 72 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sandoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAN-0791
  • 2023-000362-34 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings