Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT01845493
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-50 of both genders
2. History of episodic wheezing, chest tightness, or shortness of breath after age of 6 years consistent with asthma, or physician diagnosed asthma after age of 6 years.
3. AND: Positive methacholine test. A positive test is defined as a provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in FEV1 (PC20 methacholine). Methacholine challenge in a separate screening protocol (98-0799), or from other venues will be accepted.
4. OR: Pre and post bronchodilator FEV1 improvement by 12% or more after 4 puffs of albuterol inhaler.
5. FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma (NHANES III predicted set).
6. Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response in a separate screening protocol. Proof of allergy from other venues, including ImmunoCAP testing from a medical workup, provided by the subject, will be accepted.
7. Oxygen saturation of \> 94 % and normal blood pressure (Systolic between 150 - 90, Diastolic between 90-60 mm Hg)
8. Willing to provide information regarding health history and habits of cigarette smoke exposure;
9. Willing to avoid antioxidant vitamins and cruciferous vegetables as well as juices/drinks with added vitamin supplements for 2 days prior the baseline screening visit and throughout initial dosing period.
10. Subjects must be willing to avoid antihistamine use for 4 days prior to each session and NSAIDs for 7 days prior to each session. Nasal steroids must be held for 2 weeks prior to the session.
Exclusion Criteria:
1. Medical history or underlying health problems that preclude participation in the protocol per the study physician;
2. Current nutritional disorder such as anorexia, bulimia, irritable bowel syndrome, Crohn's disease etc;
3. Use of oral corticosteroids within the past 4 weeks;
4. Presence of upper or lower respiratory tract infection or treatment with antibiotics within the previous 4 weeks;
5. Pregnancy as determined by menstrual history or urine pregnancy test;
6. Current smokers will be excluded. Anyone with a smoking history \> 0.5 pack year and/or \>1 pack per month will also be excluded.
7. History of bleeding disorder;
8. Recent nasal surgery (with 6 months). If a subject has had nasal surgery between 6 months and 5 years, a study physician will visualize the area prior to the biopsy to evaluate the suitability of the nose for the procedure.
9. History of intolerance of or aversion to broccoli
10. Unable to withhold nasal steroids for 2 weeks before each session. These subjects may be deferred until after their allergy season.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01845493
Study Brief:
Protocol Section:
NCT01845493