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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00107910 | Other Identifier | Duke site protocol number |
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The TBS02 study was paused indefinitely. No subjects were enrolled or treated, and the study may resume if circumstances change.
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| Name | Class |
|---|---|
| Duke Health | OTHER |
| The Emmes Company, LLC | INDUSTRY |
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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.
The overall aim in Part 2 is to evaluate the optimal IV dosing of terbutaline sulfate based on PD response and safety data.
Primary Objectives:
Secondary Objective: Describe all adverse events (AEs) in participants receiving terbutaline sulfate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Terbutaline Arm D | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terbutaline | Drug | management of asthma symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK: Maximum concentration (CMAX) | Describe differences in the PK profiles of terbutaline sulfate administered via the SQ route versus the IV route. | 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. | 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 | 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 | 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 | 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. | 0-6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) | Adverse events (AEs) in participants receiving terbutaline sulfate. | 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) |
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Inclusion Criteria:
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.
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Lang, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States | ||
| University of Vermont |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 24, 2024 | Jan 16, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D013726 | Terbutaline |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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A Prospective, Blinded, Cross-over Trial of the Exposure-Response Relationship of Terbutaline Sulfate in Adults with Asthma (TBS02)
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• 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. |
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| 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. |
|
| 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. | 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. | 0-6 hours |
Serious Adverse Events (SAEs) in participants receiving terbutaline sulfate.
| 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. | From baseline through the end of study (Part I up to 60 days, Part II up to 180 days) |
| Burlington |
| Vermont |
| 05401 |
| United States |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |