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

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: Terminated
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Mometasone + Azelastine; Drug: Mometasone Furoate; Drug: Azelastine Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Cmax	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 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	The apparent first-order elimination rate constant	From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Thalf	The apparent elimination half-life	From time 0 hours (prior to dosing), up to 48 or 72 hours post dose

Collaborators and Investigators

• Sponsor: Sandoz

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Actual): September 8, 2023
• Study Completion (Actual): September 8, 2023

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Lipoxygenase Inhibitors; Mometasone Furoate; Azelastine
• Other Study ID 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