AsthmaPhase 2/3TBS02NCT04973345

Terbutaline Sulfate in Adults With Asthma

A Phase 2/3 study testing Terbutaline in people with Asthma, run by Kanecia Obie Zimmerman at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

The overall aim in Part 1 is to compare the pharmacokinetic (PK)/pharmacodynamics (PD) relationship in intravenous (IV) versus subcutaneous (SQ) terbutaline sulfate to identify the optimal IV dosing range for use in Part 2. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Asthma
What is being tested?: Terbutaline
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 2 sitesUnited States
Study dates: 7 Jul 2023to Dec 2026
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Participant has provided informed consent
History of physician-diagnosed asthma
Age ≥18 to <60 at time of consent
Past (within 12 months of consent) or current (at screening visit)evidence of airway reactivity, defined as:
Documentation of ≥10% FEV1 improvement following bronchodilator OR
Positive methacholine challenge (20% or more FEV1 decrease at ≤ 16 mg/mL)

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Willing and able to undergo study procedures and attend required study visits.
Adequate venous access for blood draws and drug administration, as determined by study investigator, or designee
Weight ≥ 40kg
FEV1 ≥ 60% predicted on day of terbutaline sulfate dosing
Systolic blood pressure (BP) ≤ 150 millimeters of Mercury (mmHg) and diastolic BP ≤ 90 mmHg measured after 10 to 15 minutes of rest
Heart rate > 45 and < 110 beats per minute (bpm) measured after 10 to 15 minutes of rest
Female participants of child-bearing potential: negative pregnancy test (urine hCG) and agreement to use effective contraception (complete abstinence from vaginal intercourse, combination barrier and spermicide, partner vasectomy, bilateral tubal ligation, intrauterine device (IUD), progestin implants, or hormonal) during study participation

Who cannot join

Self-reported pregnancy or lactating or breastfeeding
Previous enrollment in the current study (any part)
Any chronic respiratory condition besides asthma (including, but not limited to Chronic Obstructive Pulmonary Disease (COPD), emphysema, or interstitial lung disease) that in the opinion of the Principal Investigator (PI) or clinical site investigator, would make the participant unsuitable for the study
Body Mass Index (BMI) > 35 kg/m2 (class II or III obesity)
Moderate to severe renal impairment, defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2
Self-reported combustible cigarette smoking of more than 1 pack per day.

Show all 15Show fewer

Greater than 20 pack-year smoking history
Any history of cardiac disease (e.g. coronary insufficiency, cardiac arrhythmias), non-skin cancer, hyperthyroidism, diabetes mellitus type 1, uncontrolled diabetes mellitus type II (HbA1C>7.5 documented within past 12 months of screening) uncontrolled epilepsy (2 or more seizures within the past 12 months and not taking anti-seizure medication)
History of ocular, brain, abdominal or thoracic surgery in the 12 months prior to screening
Known hypersensitivity to terbutaline sulfate or albuterol
Use of any medications from the following classes within 28 days prior to Visit 1: monoamine oxidase inhibitors, tricyclic antidepressants, beta blockers, non-potassium-sparing antihypertensive diuretics, or systemic corticosteroids
Self-reported respiratory tract infection in the 14 days prior to Visit 1
Any current chronic condition or past history of disease that, in the opinion of the PI would make the participant unsuitable for the study
Baseline prolongation of QTc (QTc ≥ 460 ms by Fridericia's formula)
Participation in another research study that includes use of any investigational drug treatment within the 30 days prior to Visit 1, or planned participation during the study period.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Colorado
Aurora, Colorado, 80045
University of Vermont
Burlington, Vermont, 05401

Other trials in United States

About this study

Official title: A Prospective, Blinded, Cross-Over Trial of the Exposure-Response Relationship of Terbutaline Sulfate in Adults With Asthma

The overall aim in Part 2 is to evaluate the optimal IV dosing of terbutaline sulfate based on PD response and safety data.

Read the detailed description

Primary Objectives:

Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route versus the IV route.
Estimate a target plasma concentration and IV dose which achieves maximum FEV1 improvement from baseline and FEV1 AUC.

Secondary Objective: Describe all adverse events (AEs) in participants receiving terbutaline sulfate.

Conditions: Asthma
Being tested: Terbutaline
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TerbutalineDrug
management of asthma symptoms

Study groups in NCT04973345
Study group	Role	What they receive
Terbutaline Arm A	Experimental	• 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. Receives: Drug: Terbutaline
Terbutaline Arm B	Experimental	• 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. Receives: Drug: Terbutaline
Terbutaline Arm C	Experimental	• 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. Receives: Drug: Terbutaline
Terbutaline Arm D	Experimental	• 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. Receives: Drug: Terbutaline
Terbutaline Arm E	Experimental	• 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. Receives: Drug: Terbutaline

What is being measured

The primary outcome is the main question the study is designed to answer.

PK: Maximum concentration (CMAX)
Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route versus the IV route.
Measured: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, and next calendar day after dose
PK: Time to Research Maximum Concentration (Tmax)
Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route versus the IV route.
Measured: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours after dose
PK: Clearance (Cl)
Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route
Measured: 5 mins, 15 mins, 30 mins, 45 mins, 1 hr, 2 hrs, 3 hrs, 4 hrs, 6 hrs, after dose
PK: Volume of Distribution (Vd)
Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route
Measured: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours after dose
PK: Half Life (t1/2)
Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route
Measured: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours after dose
Concentration Achieving Maximum FEV1 Improvement (CeMax)
Estimate a target plasma concentration and IV dose which achieves maximum FEV1 improvement from baseline and FEV1 AUC 0 to 6 hours.
Measured: 0-6 hours
Area Under the Concentration Time Curve (AUC)
Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route versus the IV route.
Measured: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, and next calendar day after dose
Forced Expiratory Volume in 1 second (FEV1)
Estimate a target plasma concentration and IV dose which achieves maximum FEV1 improvement from baseline and FEV1 AUC 0 to 6 hours.
Measured: 0-6 hours

Secondary outcomes (3)

Number of Adverse Events (AEs)
Adverse events (AEs) in participants receiving terbutaline sulfate.
Measured: From baseline through the end of study (Part I up to 60 days, Part II up to 180 days)
Number of Serious Adverse Events (SAEs)
Serious Adverse Events (SAEs) in participants receiving terbutaline sulfate.
Measured: From baseline through the end of study (Part I up to 60 days, Part II up to 180 days)
Number of Suspected Unexpected Serious Adverse Reactions (SUSARs)
Suspected Unexpected Serious Adverse Reactions (SUSARs) in participants receiving terbutaline sulfate.
Measured: From baseline through the end of study (Part I up to 60 days, Part II up to 180 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jul 2023Dec 2026

First posted22 Jul 2021
Study start7 Jul 2023
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Why it stopped: The TBS02 study was paused indefinitely. No subjects were enrolled or treated, and the study may resume if circumstances change.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: A Prospective, Blinded, Cross-over Trial of the Exposure-Response Relationship of Terbutaline Sulfate in Adults with Asthma (TBS02)
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04973345
Sponsor's protocol ID: Pro00113848
Other IDs: Pro00107910
Acronym: TBS02
Status last verified: Jan 2026
First submitted: 14 Jul 2021
Last updated: 22 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Blinded, Cross-Over Trial of the Exposure-Response Relationship of Terbutaline Sulfate in Adults With Asthma
ClinicalTrials.gov ID: NCT04973345
Acronym / sponsor ID: TBS02 / Pro00113848
Conditions: Asthma
Phase: Phase 2/3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The TBS02 study was paused indefinitely. No subjects were enrolled or treated, and the study may resume if circumstances change.
Enrolment: 0 participants (actual)
Lead sponsor: Kanecia Obie ZimmermanUniversity, hospital or other
Collaborators: Duke Health, The Emmes Company, LLC
Study start: 7 Jul 2023 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 22 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The overall aim in Part 2 is to evaluate the optimal IV dosing of terbutaline sulfate based on PD response and safety data.

Detailed description

Primary Objectives:

Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route versus the IV route.
Estimate a target plasma concentration and IV dose which achieves maximum FEV1 improvement from baseline and FEV1 AUC.

Secondary Objective: Describe all adverse events (AEs) in participants receiving terbutaline sulfate.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5
Model description: A Prospective, Blinded, Cross-over Trial of the Exposure-Response Relationship of Terbutaline Sulfate in Adults with Asthma (TBS02)

Arm	Type	Receives
Terbutaline Arm A	Experimental	Drug: Terbutaline• 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.
Terbutaline Arm B	Experimental	Drug: Terbutaline• 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.
Terbutaline Arm C	Experimental	Drug: Terbutaline• 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.
Terbutaline Arm D	Experimental	Drug: Terbutaline• 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.
Terbutaline Arm E	Experimental	Drug: Terbutaline• 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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Participant has provided informed consent
History of physician-diagnosed asthma
Age ≥18 to <60 at time of consent
Past (within 12 months of consent) or current (at screening visit)evidence of airway reactivity, defined as:
Willing and able to undergo study procedures and attend required study visits.

Key exclusion criteria (15 listed)

Self-reported pregnancy or lactating or breastfeeding
Previous enrollment in the current study (any part)
Any chronic respiratory condition besides asthma (including, but not limited to Chronic Obstructive Pulmonary Disease (COPD), emphysema, or interstitial lung disease) that in the opinion of the Principal Investigator (PI) or clinical site investigator, would make the participant unsuitable for the study
Body Mass Index (BMI) > 35 kg/m2 (class II or III obesity)
Moderate to severe renal impairment, defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Terbutalinemanagement of asthma symptoms	Drug	Terbutaline Arm A, Terbutaline Arm B, Terbutaline Arm C, Terbutaline Arm D, Terbutaline Arm E

Primary outcome

PK: Maximum concentration (CMAX)
Time frame: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, and next calendar day after dose
Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route versus the IV route.
PK: Time to Research Maximum Concentration (Tmax)
Time frame: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours after dose
Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route versus the IV route.
PK: Clearance (Cl)
Time frame: 5 mins, 15 mins, 30 mins, 45 mins, 1 hr, 2 hrs, 3 hrs, 4 hrs, 6 hrs, after dose
Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route
PK: Volume of Distribution (Vd)
Time frame: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours after dose
Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route
PK: Half Life (t1/2)
Time frame: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours after dose
Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route
Concentration Achieving Maximum FEV1 Improvement (CeMax)
Time frame: 0-6 hours
Estimate a target plasma concentration and IV dose which achieves maximum FEV1 improvement from baseline and FEV1 AUC 0 to 6 hours.
Area Under the Concentration Time Curve (AUC)
Time frame: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, and next calendar day after dose
Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route versus the IV route.
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 0-6 hours
Estimate a target plasma concentration and IV dose which achieves maximum FEV1 improvement from baseline and FEV1 AUC 0 to 6 hours.

3 secondary outcomes

Number of Adverse Events (AEs)
Time frame: From baseline through the end of study (Part I up to 60 days, Part II up to 180 days)
Number of Serious Adverse Events (SAEs)
Time frame: From baseline through the end of study (Part I up to 60 days, Part II up to 180 days)
Number of Suspected Unexpected Serious Adverse Reactions (SUSARs)
Time frame: From baseline through the end of study (Part I up to 60 days, Part II up to 180 days)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Individual participant dataSharing planned: No

Related trials for Asthma

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason Lang, MD principal investigator

Duke University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Terbutaline in people with Asthma, run by Kanecia Obie Zimmerman at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK: Maximum concentration (CMAX) (time frame: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, and next calendar day after dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04973345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.