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Beta-2 Agonist

Terbutaline for Asthma (TBS02 Trial)

Q: What is the population size of this trial?

Affirmative. As per the clinicaltrials.gov listing, this medical study is presently recruiting participants. It was initially published on July 7th 2023 and its details were most recently updated on November 20th of the same year. The trial requires 30 people to be recruited from a single site.

Q: Are there any openings for the trial that need to be filled?

Affirmative. The clinical trials website reveals that this research is currently seeking volunteers. It was published on the 7th of July, 2023 and underwent its most recent update on November 20th, 2023. Aspiring participants must be aware that only 30 places are available at one trial site.

Q: Does this study accept participants aged 55 and above?

This clinical trial is only open to adults aged 18-50. However, there are 137 studies for minors and 202 aimed at the elderly population.

Q: To whom does this clinical trial offer participation?

This medical trial necessitates 30 asthmatic individuals aged between 18 and 50 years old to partake in the research. The required prerequisites for participation are: participants must have consented, been diagnosed with <a href="https://www.withpower.com/clinical-trials/asthma">asthma</a> by a physician, reveal an improvement of 12% or more FEV1 following bronchodilator administration OR demonstrate a 20% decrease of FEV1 at 16 mg/mL using methacholine challenge test; ACQ5 score ≥ 1.25; willing to commit to study procedures and visitations; adequate venous access for blood draws and drug administration as determined by investigator or designee; weight greater than 40kg;

Phase 2 & 3

Recruiting

Led By Jason Lang, MD

Research Sponsored by Kanecia Zimmerman, MD MPH

Eligibility Criteria Checklist

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

Must have

Age ≥18 to <50 at time of consent

History of physician-diagnosed asthma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 mins, 15 mins, 30 mins, 45 mins, 1 hr, 2 hrs, 3 hrs, 4 hrs, 6 hrs, after dose

Awards & highlights

TBS02 Trial Summary

This trial is testing two ways of taking terbutaline sulfate to see which is best for treating asthma, and how much is safe to take.

Who is the study for?

Adults aged 18-50 with physician-diagnosed asthma, recent symptoms, and a positive methacholine challenge can join. They must have good veins for blood draws/drug administration, normal blood pressure and heart rate ranges, weigh over 40kg, and have FEV1 ≥60%. Women of childbearing age need a negative pregnancy test and agree to use contraception.Check my eligibility

What is being tested?

The trial is testing Terbutaline Sulfate's effects on asthma when given intravenously (IV) versus subcutaneously (SQ). Part 1 identifies the best IV dose range by studying how the body processes it. Part 2 evaluates this optimal dosing based on safety data and how well it works.See study design

What are the potential side effects?

Terbutaline may cause side effects like shaking hands or tremors, headaches, nervousness or anxiety, dizziness or lightheadedness, trouble sleeping; fast heartbeat; nausea or vomiting; weakness; excessive sweating.

TBS02 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 49 years old.

Select...

I have been diagnosed with asthma by a doctor.

Select...

I've used asthma relief inhalers at least twice a week in the last month.

Select...

I weigh at least 40kg.

TBS02 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 mins, 15 mins, 30 mins, 45 mins, 1 hr, 2 hrs, 3 hrs, 4 hrs, 6 hrs, after dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 mins, 15 mins, 30 mins, 45 mins, 1 hr, 2 hrs, 3 hrs, 4 hrs, 6 hrs, after dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 mins, 15 mins, 30 mins, 45 mins, 1 hr, 2 hrs, 3 hrs, 4 hrs, 6 hrs, after dose 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 Concentration Time Curve (AUC)

Concentration Achieving Maximum FEV1 Improvement (CeMax)

Forced Expiratory Volume in 1 second (FEV1)

+5 more

Secondary outcome measures

Number of Adverse Events (AEs)

Number of Serious Adverse Events (SAEs)

Number of Suspected Unexpected Serious Adverse Reactions (SUSARs)

Side effects data

From 2010 Phase 4 trial • 116 Patients • NCT00567476

21%

Headache

13%

Sinusitis

10%

Respiratory tract infection

10%

Back pain

Nasopharyngitis

Pruritus

Upper respiratory tract infection

Pyrexia

Joint sprain

Anxiety

Rhinitis

Rhinitis allergic

Pregnancy

Pneumonia

Pneumothorax

Dysmenorrhoea

100%

80%

60%

40%

20%

Study treatment Arm

Omalizumab + Conventional Therapy

Conventional Therapy

TBS02 Trial Design

5Treatment groups

Experimental Treatment

Group I: Terbutaline Arm EExperimental Treatment1 Intervention

• Arm E: (n=6) SQ (0.25 mg) IV high dose over 5 minutes IV low dose over 5 minutes IV medium dose over 5 minutes Participants in Part 2 (n=18) will be randomized to one of three treatment arms. To maintain masking the first treatment will be 0.25 mg of study drug SQ, followed by one of three IV dose regimes (low, medium, high) below, which are estimated to be 0.1 mg, 0.5 mg, 1.0 mg, but may be adjusted based on the interim analysis completed in Part 1. No masking will be applied for Part 1 or for the SQ dosing in Part 2. All IV treatments in Part 2 will be masked, with exception to the unmasked study pharmacist, refer to the MOP for details.

Group II: Terbutaline Arm DExperimental Treatment1 Intervention

• Arm D: (n=6)SQ (0.25 mg) IV medium dose over 5 minutes IV high dose over 5 minutes IV low dose over 5 minutes Participants in Part 2 (n=18) will be randomized to one of three treatment arms. To maintain masking the first treatment will be 0.25 mg of study drug SQ, followed by one of three IV dose regimes (low, medium, high) below, which are estimated to be 0.1 mg, 0.5 mg, 1.0 mg, but may be adjusted based on the interim analysis completed in Part 1. No masking will be applied for Part 1 or for the SQ dosing in Part 2. All IV treatments in Part 2 will be masked, with exception to the unmasked study pharmacist, refer to the MOP for details.

Group III: Terbutaline Arm CExperimental Treatment1 Intervention

• Arm C: (n=6) SQ (0.25 mg) IV low dose over 5 minutes IV medium dose over 5 minutes IV high dose over 5 minutes Participants in Part 2 (n=18) will be randomized to one of three treatment arms. To maintain masking the first treatment will be 0.25 mg of study drug SQ, followed by one of three IV dose regimes (low, medium, high) below, which are estimated to be 0.1 mg, 0.5 mg, 1.0 mg, but may be adjusted based on the interim analysis completed in Part 1. No masking will be applied for Part 1 or for the SQ dosing in Part 2. All IV treatments in Part 2 will be masked, with exception to the unmasked study pharmacist, refer to the MOP for details.

Group IV: Terbutaline Arm BExperimental Treatment1 Intervention

• Arm B: (n=6) SQ administration (0.25 mg) IV bolus (0.25 mg) over 5 minutes Participants in Part 1 Arms A and B (n=12) will be randomized to one of two treatment arms.No masking will be applied for Part 1 or for the SQ dosing in Part 2. All IV treatments in Part 2 will be masked, with exception to the unmasked study pharmacist, refer to the MOP for details.

Group V: Terbutaline Arm AExperimental Treatment1 Intervention

• Arm A: (n=6) IV bolus (0.25 mg) over 5 minutes SQ administration (0.25 mg) Participants in Part 1 Arms A and B (n=12) will be randomized to one of two treatment arms.No masking will be applied for Part 1 or for the SQ dosing in Part 2. All IV treatments in Part 2 will be masked, with exception to the unmasked study pharmacist, refer to the MOP for details.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Terbutaline

2008

Completed Phase 1

~270

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kanecia Zimmerman, MD MPHLead Sponsor

2 Previous Clinical Trials

565 Total Patients Enrolled

Kanecia Obie ZimmermanLead Sponsor

8 Previous Clinical Trials

3,147 Total Patients Enrolled

Duke HealthOTHER

5 Previous Clinical Trials

2,767 Total Patients Enrolled

Frequently Asked Questions

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

What is the population size of this trial?

"Affirmative. As per the clinicaltrials.gov listing, this medical study is presently recruiting participants. It was initially published on July 7th 2023 and its details were most recently updated on November 20th of the same year. The trial requires 30 people to be recruited from a single site."

Answered by AI

Are there any openings for the trial that need to be filled?

"Affirmative. The clinical trials website reveals that this research is currently seeking volunteers. It was published on the 7th of July, 2023 and underwent its most recent update on November 20th, 2023. Aspiring participants must be aware that only 30 places are available at one trial site."

Answered by AI

Does this study accept participants aged 55 and above?

"This clinical trial is only open to adults aged 18-50. However, there are 137 studies for minors and 202 aimed at the elderly population."

Answered by AI

To whom does this clinical trial offer participation?

"This medical trial necessitates 30 asthmatic individuals aged between 18 and 50 years old to partake in the research. The required prerequisites for participation are: participants must have consented, been diagnosed with asthma by a physician, reveal an improvement of 12% or more FEV1 following bronchodilator administration OR demonstrate a 20% decrease of FEV1 at 16 mg/mL using methacholine challenge test; ACQ5 score ≥ 1.25; willing to commit to study procedures and visitations; adequate venous access for blood draws and drug administration as determined by investigator or designee; weight greater than 40kg;"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Terbutaline Sulfate in Adults With Asthma

Kanecia Obie Zimmerman 2023. "Terbutaline Sulfate in Adults With Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04973345.

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