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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01184118
Eligibility Criteria:
Inclusion Criteria:
1. age 18-65;
2. history consistent with asthma
3. symptoms consistent with NAEPP26 asthma severity step ≥2 (in the past 2-4 weeks, presence of any of the following: daytime symptoms \>2 days/week; or nighttime symptoms 3-4x/month; or short acting bronchodilator use (not for prevention of exercise induced asthma) \>2 days/week, requiring addition on a controller therapy, using the NAEPP Asthma Step Categorization guidelines
4. FEV1≥65%
5. confirmation of asthma diagnosis by bronchodilator reversibility (≥12% improvement in FEV1 from baseline following 2 puffs of a β-2 agonist) or a provocative concentration of methacholine needed to produce a 20% fall in FEV1 (PC20) of ≤ 8 mg/ml.
Exclusion Criteria:
1. any use of inhaled corticosteroid for \>2 weeks at a time during the last 6 months, or any use in the last 6 weeks
2. as needed use of nasal steroids in the prior 6 months (regular use is allowed without washout needed prior to testing visits)
3. use of medications listed in Table 1. Inhaled long acting β-adrenergics are permitted for entry and should be continued during this study
4. respiratory infection during the prior 4 weeks or asthma exacerbation during the prior 6 weeks to enrollment
5. presence of other lung diseases
6. evidence of significant medical (such as angina, heart failure, stroke) or psychiatric illnesses
7. diagnosed osteopenia (on treatment) or osteoporosis
8. established diagnosis of neuromuscular disease (e.g. multiple sclerosis, syringomyelia, transverse myelitis, amyotrophic lateral sclerosis (ALS), poliomyelitis, Lambert Eaton syndrome, Guillain-Barre syndrome, myasthenia gravis, myotonic dystrophy, mononeuritis multiplex, in the setting of polymyositis/dermatomyositis or severe cervical spine disease)
9. BMI greater than 35 kg/m2
10. currently on treatment for OSA
11. new diagnosis of OSA if OAI \> 10/hour or desaturation \<70% on dPSG (V2
12. pregnancy or desire to get pregnant in the upcoming 6 months (subjects of child-bearing potential must agree to use an acceptable method of birth control per ACRN guidelines, as stated in the consent form: i.e. if not post-menopausal \[1 year or more since last menses\] or surgically sterile \[hysterectomy, tubal ligation, or vasectomy in monogamous partner\], subject must use one of the following acceptable birth control methods: abstinence, birth control pills, diaphragm, intra-uterine device \[IUD\], Norplant, Depo-Provera, NuvaRing, birth control patches \[e.g., Ortho Evra\], single or double barrier methods \[condom plus foam/jelly or condom plus diaphragm\])
13. cigarettes \> 1pack/month or cigars in the year before study or overall tobacco use greater than 10 pack years
14. inability to abstain from alcohol ingestion for 24 hours prior to sleep studies
15. any current use of benzodiazepins, opioids or barbiturates; 16) any current use of recreational drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01184118
Study Brief:
Protocol Section:
NCT01184118