NCT01225913 Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
| NCT ID | NCT01225913 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Gelb, Arthur F., M.D. |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2007-10 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2007-10 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the site and mechanisms responsible for expiratory airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to severe persistent expiratory airflow obstruction. Treatment will include inhaled corticosteroids and long acting beta2agonists. The investigators are interested in determining whether the large and/or small airways are the predominant site of airflow limitation. The investigators are also interested in determining whether intrinsic small airways obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow limitation. The investigators are also interested to evaluate the role of varying doses of inhaled corticosteroids to suppress large and small airway inflammation using exhaled nitric oxide as surrogate markers of inflammation. For comparison purposes, spirometry and measurements of exhaled nitric oxide will also be obtained if possible during a naturally occurring exacerbation of asthma.
Eligibility Criteria
Inclusion Criteria: * Current non-smoking (\<10 pack yr smoking history) * Stable, treated asthmatics * Age 10-80 yr * post 180ug albuterol by MDI: FEV 1/FVC \< 70% and FEV 1 \<80% predicted Exclusion Criteria: * Pregnancy
Contact & Investigator
Arthur F Gelb, MD
PRINCIPAL INVESTIGATOR
Arthur F Gelb Medical Corporation
Frequently Asked Questions
Who can join the NCT01225913 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 80 Years, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01225913 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT01225913 currently recruiting?
Yes, NCT01225913 is actively recruiting participants. Contact the research team at afgelb@msn.com for enrollment information.
Where is the NCT01225913 trial being conducted?
This trial is being conducted at Lakewood, United States.
Who is sponsoring the NCT01225913 clinical trial?
NCT01225913 is sponsored by Gelb, Arthur F., M.D.. The principal investigator is Arthur F Gelb, MD at Arthur F Gelb Medical Corporation. The trial plans to enroll 50 participants.
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