Asthma drug study pulled before it began
NCT ID NCT04973345
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study was designed to understand how the asthma drug terbutaline sulfate works in the body when given through a vein versus under the skin. Researchers planned to enroll adults with asthma to find the best dose. However, the trial was withdrawn before any participants were enrolled, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- terbutaline sulfate
- What could go wrong
- The trial was withdrawn before enrolling any participants, so no data was collected. It is unclear if the approach would have been safe or effective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Started
-
Jul 2023
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participant has provided informed consent 2. History of physician-diagnosed asthma 3. Age ≥18 to \<60 at time of consent 4. 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) 5. Willing and able to undergo study procedures and attend required study visits. 6. Adequate venous access for blood draws and drug administration, as determined by study investigator, or designee 7. Weight ≥ 40kg 8. FEV1 ≥ 60% predicted on day of terbutaline sulfate dosing 9. Systolic blood pressure (BP) ≤ 150 millimeters of Mercury (mmHg) and diastolic BP ≤ 90 mmHg measured after 10 to 15 minutes of rest 10. Heart rate \> 45 and \< 110 beats per minute (bpm) measured after 10 to 15 minutes of rest 11. 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: 1. Self-reported pregnancy or lactating or breastfeeding 2. Previous enrollment in the current study (any part) 3. 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 4. Body Mass Index (BMI) \> 35 kg/m2 (class II or III obesity) 5. Moderate to severe renal impairment, defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2 6. Self-reported combustible cigarette smoking of more than 1 pack per day. 7. Greater than 20 pack-year smoking history 8. 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) 9. History of ocular, brain, abdominal or thoracic surgery in the 12 months prior to screening 10. Known hypersensitivity to terbutaline sulfate or albuterol 11. 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 12. Self-reported respiratory tract infection in the 14 days prior to Visit 1 13. Any current chronic condition or past history of disease that, in the opinion of the PI would make the participant unsuitable for the study 14. Baseline prolongation of QTc (QTc ≥ 460 ms by Fridericia's formula) 15. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Colorado
Aurora, Colorado, 80045, United States
-
University of Vermont
Burlington, Vermont, 05401, United States
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