A Double Blind Open Label Comparator Study to Compare Treatments in 4 to 11 Year Old Patients With Asthma

NCT ID: NCT02680561

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-08-31

Brief Summary

The purpose of the study is to characterize the pharmacokinetic profiles of fluticasone propionate and/or salmeterol when delivered as a single oral inhalation dose of Fp MDPI and FS MDPI.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment A: Fp MDPI

Single inhalation dose of Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) on Day 1 into 1 of 6 treatment sequences (ABC, BCA, CAB, ACB, BAC, or CBA)

Group Type: EXPERIMENTAL

Fluticasone Propionate MDPI

Intervention Type: DRUG

Fluticasone Propionate/Salmeterol MDPI

Intervention Type: DRUG

Fluticasone propionate/salmeterol

Intervention Type: DRUG

Treatment B: FS MDPI

Single inhalation dose of Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) on Day 1 into 1 of 6 treatment sequences (ABC, BCA, CAB, ACB, BAC, or CBA)

Group Type: EXPERIMENTAL

Fluticasone Propionate MDPI

Intervention Type: DRUG

Fluticasone Propionate/Salmeterol MDPI

Intervention Type: DRUG

Fluticasone propionate/salmeterol

Intervention Type: DRUG

Treatment C: Comparator

Single inhalation dose of fluticasone propionate/salmeterol (ADVAIR DISKUS) on Day 1 into 1 of 6 treatment sequences (ABC, BCA, CAB, ACB, BAC, or CBA)

Group Type: ACTIVE_COMPARATOR

Fluticasone Propionate MDPI

Intervention Type: DRUG

Fluticasone Propionate/Salmeterol MDPI

Intervention Type: DRUG

Fluticasone propionate/salmeterol

Intervention Type: DRUG

Interventions

Fluticasone Propionate MDPI

Intervention Type: DRUG

Fluticasone Propionate/Salmeterol MDPI

Intervention Type: DRUG

Fluticasone propionate/salmeterol

Intervention Type: DRUG

Other Intervention Names

Fp MDPI; FS MDPI; ADVAIR; DISKUS

Eligibility Criteria

Inclusion Criteria

• The patient is a male or female aged 4 through 11 years of age, inclusive
• Severity of disease: The patient has persistent asthma
• Asthma diagnosis: The patient has a diagnosis of asthma as defined by the NIH.
• The patient has required less than 4 inhalations per week of rescue bronchodilator (on average) for the 4 weeks preceding the SV.
• The patient is able to withhold (as judged by the investigator) his or her rescue medication for at least 6 hours before the SV and before all treatment visits.
• The patient must have a weight of 18 kg or higher.

• Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria

• The patient has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures.
• Female patients that have reached puberty and have a child bearing potential must have a negative serum pregnancy test at the SV. Eligible menstruating female patients unwilling to employ appropriate birth control measures to ensure pregnancy will be excluded
• The patient has participated as a randomized patient in any investigational drug study within 30 days (starting from the final follow-up visit of that study) preceding the SV or plans to participate in another investigational drug study at any time during this study.
• The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the study drug (ie, lactose).
• The patient has a culture-documented or suspected bacterial or viral upper respiratory tract infection (URTI) or lower respiratory tract infection (LRTI), sinus, or middle ear that has not resolved at least 2 weeks before the SV.
• The patient has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV, or has had any hospitalization for asthma within 2 months before the SV.
• The patient has used immunosuppressive medications within 4 weeks before the SV.
• The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study. Note: Azole antifungals are prohibited.
• The patient is an immediate relative of an employee of the investigational center.
• Patients who have donated whole blood 60 days before the first dose, or receive or donate plasma, white blood cells, or platelets within the 14 days before the first dose or study drug, and for 90 days after last dose of study drug.
• The patient has a disease/condition that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.

• Additional criteria apply, please contact the investigator for more information.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 13679

Huntington Beach, California, United States

Teva Investigational Site 13678

Raleigh, North Carolina, United States

Teva Investigational Site 13677

San Antonio, Texas, United States

Countries

United States

Other Identifiers

FSS-PK-10007

Identifier Type: -

Identifier Source: org_study_id