Asthma drug study pulled before it began

NCT ID NCT04973345

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 However, the trial was withdrawn before any participants were enrolled, so no results are available.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The trial was withdrawn before enrolling any participants, so no data was collected.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

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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