Asthma Trial, Recruiting NCT06317909 Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine Condition: Asthma
Back to Asthma

Asthma Trial, Recruiting

NCT06317909
Recruiting Not Applicable

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:

  • People who are willing and able to give written consent to participate
  • Adults between 18 and 65 years of age
  • Women who are not pregnant (confirmed by a pregnancy test), not breastfeeding, and either unable to become pregnant naturally or using a highly effective form of contraception throughout the study (such as implants, injections, the pill, hormonal IUDs, or double-barrier methods)
  • People who have had mild asthma for at least 12 months before screening, managed only with a short-acting reliever inhaler (such as a "blue puffer")
  • People whose body weight is in a healthy range for their height (BMI between 18 and 32)
  • People whose lung function tests show results within normal limits at the screening visit
  • People who have had a positive skin prick allergy test (a reaction of 3mm or more) to a specific airborne allergen such as grass, tree, weed pollen, or house dust mite, within the past 12 months (confirm with trial site)
  • People who have shown both an early and late asthmatic reaction during a previous inhaled allergen challenge test (confirm with trial site)
  • People who are able to produce an adequate sputum (mucus) sample when tested (confirm with trial site)
  • Non-smokers who have smoked less than the equivalent of one pack of cigarettes per year in total, and have not smoked for at least the past year

Who may not be able to join:

  • People with any significant abnormal results on physical examination, blood tests, urine tests, heart tracing (ECG), or lung function at screening, where the trial doctor believes this could affect safety or results
  • People with a current or past serious illness that the investigator believes may affect the study, including heart disease, cancer, liver disease, kidney disease, blood disorders, neurological conditions, most metabolic or hormonal conditions, or lung diseases such as emphysema, chronic bronchitis, tuberculosis, or cystic fibrosis (note: stable, symptom-free underactive thyroid and a condition called Gilbert's syndrome are generally allowed)
  • People who regularly take any prescription or over-the-counter medicines, with exceptions for paracetamol, contraceptives, hormone replacement therapy, and vitamin or dietary supplements
  • People who have had allergen immunotherapy (desensitisation treatment) within the past three years
  • People who have taken steroid medicines (by mouth, injection, or inhaler) in the four weeks before the screening visit
  • People who have had a respiratory tract infection (such as a chest or throat infection) in the four weeks before the screening visit
  • People who have had an asthma flare-up in the three months before the screening visit
  • People who have ever had a life-threatening asthma attack that required a breathing tube or caused a respiratory emergency
  • People who may be allergic to any of the medicines used during the bronchoscopy procedure, such as bronchodilators, sedatives, or local anaesthetics
  • People who have any condition that would make a bronchoscopy (a procedure to look inside the airways) or allergen challenge test unsafe or not possible
  • People who are unable to have an MRI scan, for example due to claustrophobia, a pacemaker, or a known allergy to MRI contrast dye
  • People who have taken part in a clinical trial involving an investigational medicine within the past 30 days, or within 5 half-lives of that medicine (whichever period is longer)
  • People currently in the observation period of another competing study within 30 days before screening
  • People who have had a segmental allergen challenge procedure (a specific airway test) within three months before the bronchoscopy
  • People who have donated more than 400ml of blood in the 60 days before screening
  • People with a history of regular drug or alcohol misuse
  • People who the investigator believes are unlikely to follow the study procedures
  • People who may not be able to understand the requirements and instructions of the study

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 9 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +49 511 5350-8101

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
Not Applicable
Sponsor
Fraunhofer-Institute of Toxicology and Experimental Medicine
Registry
ClinicalTrials.gov
Start date
9 August 2024
Est. completion
1 September 2026

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Exploratory (1. priority) Changes in soluble mediators [i.e. IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, INF-alpha, MMP-9, CXCL1, SP-D, albumin] in Bronchoalveolar lavage (BAL) after segmental allergen challenge; Exploratory (1. priority) Changes in soluble mediators [i.e. IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin] in Sputum after inhalative allergen challenge; Exploratory (1. priority) Changes in non-invasive exhaled particles [i.e.IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin]after inhalative allerg...

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: 9 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