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Sequence 6 for Asthma

Phase 1

Recruiting

Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 months

Awards & highlights

Study Summary

This trial aims to study how the drugs fluticasone propionate (Fp) and albuterol sulfate (ABS) work together when taken as a single dose using a dry powder inhal

Who is the study for?

This trial is for children aged 4 to 11 with stable asthma, as per GINA guidelines. They should have had asthma for at least 3 months, an FEV1 ≥80% of the predicted value, and demonstrate good inhaler technique. Their BMI must be within the normal range for their age and gender, weigh at least 18 kg, and achieve a PIF rate of ≥60 L/min.Check my eligibility

What is being tested?

The study tests TEV-56248 (a combination inhaler with fluticasone propionate and albuterol sulfate) against Fp MDPI alone in kids with asthma. It aims to compare how the body processes these drugs by measuring drug levels after dosing.See study design

What are the potential side effects?

Potential side effects may include typical reactions to inhaled steroids or bronchodilators such as coughing, headaches, throat irritation or potentially more serious effects like allergic reactions or worsening of asthma symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS

Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp

Last Measurable Concentration Above the Quantification Limit (Clast) of ABS

+9 more

Secondary outcome measures

Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs)

Number of Participants with Adverse Events (AEs)

Number of Participants with Serious Adverse Events (SAEs)

Trial Design

6Treatment groups

Experimental Treatment

Group I: Sequence 6Experimental Treatment2 Interventions

Group II: Sequence 5Experimental Treatment2 Interventions

Group III: Sequence 4Experimental Treatment2 Interventions

Group IV: Sequence 3Experimental Treatment2 Interventions

Group V: Sequence 2Experimental Treatment2 Interventions

Group VI: Sequence 1Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fp MDPI

2012

Completed Phase 3

~4300

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor

251 Previous Clinical Trials

3,485,354 Total Patients Enrolled

63 Trials studying Asthma

2,616,189 Patients Enrolled for Asthma

Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.

93 Previous Clinical Trials

38,757 Total Patients Enrolled

22 Trials studying Asthma

12,618 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the eligibility criteria to be enrolled in this research study?

"To be eligible for participation in this research, candidates must have a diagnosis of asthma and fall within the age bracket of 4 to 11 years. The study aims to enroll a total of 22 individuals."

Answered by AI

What are the safety considerations for individuals using Sequence 6?

"Based on our evaluation, the safety rating for Sequence 6 is graded as a 1. This assessment aligns with it being categorized as a Phase 1 trial, denoting minimal available evidence backing its safety and effectiveness."

Answered by AI

How large is the participant pool for this clinical trial in its entirety?

"Indeed, clinicaltrials.gov data indicates that this trial is currently enrolling participants. The study was first uploaded on April 2nd, 2024 and underwent its latest revision on April 12th, 2024. This research project aims to recruit a total of 22 patients from one designated site."

Answered by AI

Are there still available openings for new participants in this research study?

"Indeed, the details on clinicaltrials.gov indicate that this research study is presently seeking participants. This trial first appeared on 4/2/2024 and was most recently modified on 4/12/2024. The aim is to recruit 22 individuals from a single site for this study."

Answered by AI