BridgeMD
New treatment option for Mild Allergic Asthma
Official title Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With Mild Allergic Asthma
ClinicalTrials.gov ID: NCT06317909
What this study is testing
- What it's testing
- The goal of this exploratory method-development study is to to establish and evaluate novel non-invasive methods to monitor airway inflammation induced by allergen challenge (both by instillation during bronchoscopy and by inhalation) in patients with mild allergic asthma. The investigator wants to further profile and develop the allergen challenge model by investigating the utility of various non-invasive monitoring methods.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Able and willing to give written informed consent.
- Male and female people aged 18-65 years. Women will be considered for inclusion if they are:
- Not pregnant, as confirmed by pregnancy test (see assessment schedule), and not nursing.
- Of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarcheal or post-menopausal...
- Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence...
You likely can't join if
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function or ECG at...
- 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...
- Regular intake of any prescribed or over the counter medication. Exceptions include paracetamol for pain relief, contraceptive medication, hormonal...
- Specific Immunotherapy (SIT) within three years prior to the study.
- Intake of systemic or inhaled steroids within 4 weeks before Screening Visit 1a.
- Respiratory tract infection (RTI) within 4 weeks before Screening Visit 1a.
See the full eligibility criteria
Who can join
- Able and willing to give written informed consent.
- Male and female people aged 18-65 years. Women will be considered for inclusion if they are:
- Not pregnant, as confirmed by pregnancy test (see assessment schedule), and not nursing.
- Of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarcheal or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets...
- Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence, implants, injectables, combined oral contraceptives, hormonal Intrauterine...
- History of mild asthma for at least 12 months prior to the Screening Visit that is well controlled with Short Acting Beta-Adrenergic Stimulator (SABA) only.
- Body mass index between 18 and 32 kg/m2
- Normal pulmonary function with forced Expiratory Volume in the first second (FEV1) ≥80% of predicted normal and FEV1/Forced Vital Capacity(FVC) ≥70% at Screening Visit. Calculations will be based on Global Lung Function...
- Positive skin prick test (wheal diameter reaction ≥3 mm) for the respective challenge aeroallergen (i.e. tree, weed, grass or house dust mite) at or within 12 months prior to the Screening Visit (if performed and...
- Positive early and late asthmatic response upon incremental inhaled allergen challenge at or prior to the Screening Visit (if performed and documented at Fraunhofer ITEM).
- Production of adequate sputum with ≥1 x 106 total non-squamous cells at or within 12 month prior to the Screening Visit 1 (if not performed and documented at Fraunhofer ITEM).
- Nonsmokers with a history of less than 1 pack year having been nonsmokers for at least one year.
What rules you out
- 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...
- 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...
- Regular intake of any prescribed or over the counter medication. Exceptions include paracetamol for pain relief, contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements.
- Specific Immunotherapy (SIT) within three years prior to the study.
- Intake of systemic or inhaled steroids within 4 weeks before Screening Visit 1a.
- Respiratory tract infection (RTI) within 4 weeks before Screening Visit 1a.
- Mild to moderate asthma exacerbation within 3 months before Screening Visit 1a.
- Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
- Suspected hypersensitivity to any ingredients of the medication in line with bronchoscopy (bronchodilators, sedatives and local anesthetics).
- Conditions or factors, which would make the subject unlikely to be able to undergo bronchoscopy or allergen challenge.
- Conditions or factors, which would make the subject unlikely to undergo MRI (e.g. due to claustrophobia, cardiac pacemaker, hypersensitivity to MR i.v. contrast imaging agents).
- Participation in another clinical trial with Investigational Medicinal Product (IMP) 30 days or 5 half-lives, whichever is longer, prior to enrollment.
- Participation in the observation period of a competing study within 30 days prior to Screening.
- Segmental allergen challenge three months prior to bronchoscopy.
- Donation of more than 400 ml of blood the preceding 60 days before screening.
- History of regular drug or alcohol abuse
- Risk of non-compliance with study procedures.
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hanover, Lower Saxony, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanover, Lower Saxony, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.