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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-08

Study Completion Date

2023-09-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prospective, Randomized, Multinational, Multicenter, Double-blind, Placebo and Active Controlled Trial in 4 Parallel-groups of Patients Suffering From Seasonal Allergic Rhinitis

NCT05311475

Seasonal Allergic Rhinitis

COMPLETED PHASE3

Efficacy and Safety of Mometasone Furoate Plus Azelastine HCl Combination Versus Mometasone Furoate Alone or Azelastine Alone in Patients With Perennial Allergic Rhinitis

NCT01470053

Perennial Allergic Rhinitis

COMPLETED PHASE3

Azelastine Allergen Chamber - Onset of Action Study

NCT06126952

Seasonal Allergic Rhinitis

COMPLETED PHASE2

Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic Rhinitis

NCT04264637

Allergic Rhinitis

COMPLETED PHASE3

Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

NCT02125253

Seasonal Allergic Rhinitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Seasonal Allergic Rhinitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride

Group Type EXPERIMENTAL

Mometasone + Azelastine

Intervention Type DRUG

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

Mometasone Furoate

Intervention Type DRUG

Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril

Azelastine Hydrochloride

Intervention Type DRUG

Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril

Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine

Group Type EXPERIMENTAL

Mometasone + Azelastine

Intervention Type DRUG

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

Mometasone Furoate

Intervention Type DRUG

Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril

Azelastine Hydrochloride

Intervention Type DRUG

Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril

Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate

Group Type EXPERIMENTAL

Mometasone + Azelastine

Intervention Type DRUG

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

Mometasone Furoate

Intervention Type DRUG

Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril

Azelastine Hydrochloride

Intervention Type DRUG

Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mometasone + Azelastine

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

Intervention Type DRUG

Mometasone Furoate

Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril

Intervention Type DRUG

Azelastine Hydrochloride

Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No