A Phase 4 interventional study of fluticasone/salmeterol in all asthmatics and budesonide/formoterol or fluticasone/salmeterol in all asthmatics in Asthma, sponsored by Gelb, Arthur F., M.D.. Recruiting at 1 site in United States. Open to participants aged 10 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Gelb, Arthur F., M.D. · Phase 4, Interventional, and Basic science
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.
In addition we will also obtain above studies in asthmatics during naturally occuring exacerbation of asthma and following treatment. If available, results of lung function studies including measurements of lung elastic recoil will be compared to pathologic analyses of formalin fixed, air inflated lungs obtained at autopsy in asthmatics who die from asthma related or non-asthma related death. This kind of lung structure-function study will provide potential mechanism(s) to explain the loss of lung elastic recoil in acute and chronic asthmatics who are non-smokers. We will also obtain voxel quantification of high resolution thin section CT of lung obtained without IV contrast. Also, we will use fiberoptic bronchoscopy to obtain optical coherence tomography in stable asthmatics with mild to moderate to severe expiratory airflow limitation to assess integrity of the lung parenchyma.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 50 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Gelb, Arthur F., M.D. is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Asthmatics in this arm may be on varying dose of inhaled fluticasone 100-500mcg/salmeterol 50mcg bid via Advair MDI or equivalent dose via Diskus bid or Symbicort (budesonide 80-160mcg/formoterol 4.5mcg bid)or Dulera 100-200mcg mometasone/5 mcg formoterol bid, tiotropium 18mcg capsule daily. This is an observational study and additional pharmacologic intervention may include antibiotic and tapering doses of corticosteroids.
Drug: fluticasone/salmeterol in all asthmatics · Drug: budesonide/formoterol or fluticasone/salmeterol in all asthmatics
budesonide 80ug/formoterol 4.5ug, 2 inhalations bid X 20-60 days or fluticasone 100ug/salmeterol 50ug, 1 inhalation bid X 20-60 days
Also known as: symbicort 80/4.5, advair 100/50 or 250/50 or 500/50 bid
budesonide 160ug/formoterol 4.5ug, 2 inhalations bid or fluticasone 250ug/salmeterol 50ug, 1 inhalations bid
Also known as: symbicort 160/4.5, advair 250/50
Exhaled nitric oxide
evaluate the role of inhaled corticosteroid on exhaled nitric oxide production in large airways and peripheral small airways/alveoli
Time frame: 20-60 days
Mechanism(s) of expiratory airflow limitation
loss of lung elastic recoil vs intrinsic airway obstruction
Time frame: 1 to 5 years
Presence of unsuspected emphysema by autopsy or explanted lung
Analysis of lungs obtained at autopsy or explanted lung for extent of emphysema
Time frame: 1-5 years
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gelb, Arthur F., M.D.