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

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05887843
• Other study ID #: SAN-0791
• Secondary ID: 2023-000362-34
• Status: Terminated
• Phase: Phase 1
• Start date: June 8, 2023
• Est. completion date: September 8, 2023

Study information

• Verified date: September 2023
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: September 8, 2023
• Est. primary completion date: September 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Mometasone + Azelastine
Mometasone + Azelastine, 50 µg/140 µg (per actuation) liquid, nasal spray, two actuations administered in each nostril
• Mometasone Furoate
Mometasone Furoate 50 µg (per actuation) nasal spray, two actuations administered in each nostril
• Azelastine Hydrochloride
Azelastine Hydrochloride 140 µg (per actuation) nasal spray, two actuations administered in each nostril

Locations

Country	Name	City	State
Canada	Sandoz Investigational Site	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Cmax	Maximum measured analyte concentration over the sampling period.	From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Primary	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
Primary	Kel	The apparent first-order elimination rate constant	From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Primary	Thalf	The apparent elimination half-life	From time 0 hours (prior to dosing), up to 48 or 72 hours post dose