Phase 1 Asthma Trial, Recruiting NCT06433921 Sponsor: GlaxoSmithKline Condition: Asthma
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Phase 1 Asthma Trial, Recruiting

NCT06433921
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are male or female, aged 18 to 65 years old at the time of screening.
  • You weigh at least 50 kg (about 110 lbs) at the time of screening.
  • Your Body Mass Index (BMI) — a measure of body weight relative to height — is between 19.0 and 35.0 at the time of screening.
  • You have a documented history of asthma for at least 6 months.
  • You have been on one of the following stable asthma treatments for at least 12 weeks before screening: a short-acting reliever inhaler only; a low-dose daily steroid inhaler (with or without a reliever inhaler); or a low-dose daily steroid inhaler combined with a long-acting reliever inhaler (with or without a short-acting reliever inhaler).
  • You have not had a severe asthma attack in the past 6 months, and no more than one severe attack in the past 12 months.
  • Your lung function test (a breathing test called FEV1) shows your lungs are working at 80% or more of what is expected for someone your age and size.
  • You show a certain level of airway sensitivity during a specific breathing challenge test using a substance called methacholine (confirm with trial site).
  • You are able to stop using your short-acting reliever inhaler for at least 12 hours, and your long-acting inhaler for at least 48 hours, before certain study visits.
  • If you are a woman, you are not pregnant or breastfeeding, and either cannot become pregnant or are using a highly effective method of contraception.
  • You are willing and able to sign a consent form agreeing to the study's requirements.
  • You are a non-smoker and have not used any tobacco products in the past 12 months, and have smoked fewer than 10 pack-years total in your lifetime (confirm with trial site).

Who may not be able to join:

  • You have a history of life-threatening asthma, or your asthma is currently considered unstable by a doctor.
  • You have a history of other lung or breathing conditions, such as chronic bronchitis, emphysema, cystic fibrosis, pulmonary fibrosis, tuberculosis, or similar conditions.
  • You have asymptomatic gallstones (gallstones that are not causing symptoms).
  • You have a current or past history of blood, nerve, psychiatric, or other health conditions that a doctor feels could put you at risk during the study.
  • You have had recent eye surgery, or have any condition where forceful breathing out could be harmful to you (confirm with trial site).
  • You are currently taking a type of medication called a cholinesterase inhibitor (for example, a medication used to treat a condition called myasthenia gravis).
  • You have taken part in more than 4 experimental drug studies in the past 12 months, or have been in another clinical trial within the past 30 days (or longer, depending on the study drug used).
  • You currently work night shifts, or have worked night shifts in the past 15 days.
  • You regularly drink more than 21 units of alcohol per week (if male) or more than 14 units per week (if female) within the past 6 months.
  • You test positive for recreational drugs (including cannabis/THC) at screening.
  • You have smoked cigarettes, cigars, pipes, or used any vaping or nicotine products within the past 12 months.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 877-379-3718

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
14 August 2024
Est. completion
26 February 2027

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Part 1 & Part 2: Provocative concentration of methacholine causing at least a 20% fall in FEV1 (PC20)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov