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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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Mometasone + Azelastine
Mometasone Furoate
Azelastine Hydrochloride
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

12 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • Sandoz Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride

Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine

Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
Cmax
Maximum measured analyte concentration over the sampling period.
Tmax
Time of the maximum measured analyte concentration over the sampling period.
Kel
The apparent first-order elimination rate constant
Thalf
The apparent elimination half-life

Secondary Outcome Measures

Full Information

First Posted
May 24, 2023
Last Updated
September 26, 2023
Sponsor
Sandoz
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1. Study Identification

Unique Protocol Identification Number
NCT05887843
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Business decision (no safety concerns).
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
September 8, 2023 (Actual)
Study Completion Date
September 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride
Arm Type
Experimental
Arm Title
Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine
Arm Type
Experimental
Arm Title
Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mometasone + Azelastine
Intervention Description
Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril
Intervention Type
Drug
Intervention Name(s)
Mometasone Furoate
Intervention Description
Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril
Intervention Type
Drug
Intervention Name(s)
Azelastine Hydrochloride
Intervention Description
Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril
Primary Outcome Measure Information:
Title
AUCt
Description
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.
Time Frame
From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Title
AUCinf
Description
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.
Time Frame
From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Title
Cmax
Description
Maximum measured analyte concentration over the sampling period.
Time Frame
From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Title
Tmax
Description
Time of the maximum measured analyte concentration over the sampling period.
Time Frame
From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Title
Kel
Description
The apparent first-order elimination rate constant
Time Frame
From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Title
Thalf
Description
The apparent elimination half-life
Time Frame
From time 0 hours (prior to dosing), up to 48 or 72 hours post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Facility Information:
Facility Name
Sandoz Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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