Can a pinpoint pollen dose unmask allergy triggers?

NCT ID NCT05346718

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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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This study aims to find the lowest concentrations of ragweed and birch pollen that cause allergy symptoms in people with seasonal allergic rhinitis. Participants sit in a special chamber where pollen levels are carefully controlled, and their nasal symptoms are measured. The goal is to understand how potent ragweed pollen is compared to birch pollen.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ragweed pollen, birch pollen, and clean air (placebo) exposure in an allergen challenge chamber
What this could lead to
If successful, this could help set evidence-based pollen warning thresholds and improve allergy management for ragweed and birch.
What could go wrong
This is a small, early-phase study with only 18 participants, so results may not apply broadly. Allergic reactions during exposure are a risk.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

18 people

The number who actually took part.

Started

Sep 2022

Finished

Dec 2024

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 65 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. Able and willing to give written informed consent. 2. Male and female subjects, aged 18-65 years. Women will be considered for inclusion if they are: 1. Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. 2. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). 3. Of childbearing potential and using a highly effective birth control during the entire study as described in section 8.2. 3. Body mass index between 18 and 35 kg/m2. 4. History of seasonal allergic rhinitis to ragweed (July to September) or birch pollen (March to May). 5. Positive skin prick test response (positive wheal diameter reaction of ≥ 3mm) for Ambrosia artemisiifolia or Betula pendula at screening or within 12 months prior to screening visit. 6. Subject has a serum specific IgE level (≥ 0.7 kU/L) to Ambrosia artemisiifolia or Betula pendula at screening or within the past 12 months (record required). 7. Normal lung function (FEV1 ≥ 80% pred. and FEV1/FVC ≥ LLN) at screening. If subject fails to meet criteria, assessment may be repeated 2 additional times. 8. TNSS of 0 prior to entering the ACC at all exposures. 9. Mild to moderate level of rhinitis symptoms in the screening challenge to ragweed or birch, defined as a mean TNSS between 1 to 8 after the 4-hour ACC and a TNSS continuously \> 0 after 40 minutes. Exclusion Criteria: 1. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function or ECG at screening visit , which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study. 2. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis). 3. Subjects with concomitant allergies to seasonal aeroallergens (i.e., grass, trees, weeds, rye; defined as IgE ≥ 3.5 kU/L within the last 12 months prior to screening) which are anticipated to be or become active during study participation. 4. Subjects with a symptomatic concomitant allergy to an animal dander being exposed during study participation. 5. Subjects with a symptomatic house dust mite allergy. 6. Symptoms of a respiratory tract infection within 3 days prior to screening. Subjects may be re-screened if they have been asymptomatic for at least 3 days. 7. Asthma requiring more than Step 1 medication according to GINA guidelines (Global Initiative for Asthma Management and Prevention, 2021). Asthmatic subjects taking ICS plus long-acting bronchodilator as needed according to Step 1 must to be switched to salbutamol as needed during study participation. 8. Intake of prohibited medication (refer to Section 9.2). 9. Smokers who are unable to refrain from smoking within 1 hr prior to and during visits. 10. Anatomical nasal abnormalities, pronounced nasal septum deviation or nasal polyps blocking nasal air flow on examination or recent nasal surgery. 11. Participation in a clinical trial with a medicinal product or medical device 30 days prior to Visit 1. 12. History of drug or alcohol abuse in the past 12 months. 13. Specific Immunotherapy (SIT) against birch or ragweed within 5 years prior to the study. 14. Risk of non-compliance with study procedures. 15. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.

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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

  • Fraunhofer Institute for Toxicology and Experimental Medicine

    Hanover, Lower Saxony, 30625, Germany

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