Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma

Part of paid clinical trials in Lakewood, California.

Sponsor
Gelb, Arthur F., M.D.
Study ID
NCT00576069
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • budesonide/formoterol — DRUG
    2 inhalations 2X/daily in treated arm/group. No placebo group
  • fluticasone/salmeterol — DRUG
    fluticasone 100ug/salmeterol 50ug, 1 inhalation bid noplacebo fluticasone 250ug/salmeterol 50ug, 1 inhalations bid no placebo Spiriva handihaler daily or respihaler 2 inhalations daily no placebo group
  • mometasone/formoterol — DRUG
    200/5 mcg two puffs bid 100/5 mcg two puffs bid Breo Ellipta once daily Spiriva capsule handihaler once daily or Spiriva respihaler 2 in no placebo group
  • Prednisone — DRUG
    0-15 mg daily as needed

Study Details

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 and long acting muscarinic antagonists. We are interested in determining whether the large and/or small airways are the predominant site of airflow limitation. We are also interested in determining whether intrinsic small airways obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow limitation and to what extent may be attributed to loss of lung elastic recoil vs decreased airway conductance in peripheral airways. We 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. High resolution thin section CT of the lung will also be obtained. Analysis will evaluate integrity of the lung parenchyma as to absence and or presence of emphysema and extent of emphysema using voxel quantification. We will also investigate optical coherence tomography to detect clinically unsuspected emphysema. We will also obtain autopsy material when available in asthmatics who expire. Will also measure serum periostin as a marker of inflammation by collaborating with Genetech in San Francisco.

Key Dates

Start date
Oct 25, 2007
Status verified
Oct 2023
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: asthma, quality of life, lung function
    All Asthmatics will be treated with 1 of 3 long acting beta 2 agonist + corticosteroid using low or medium dose of inhaled (Advair) fluticasone or equivalent corticosteroid 200-500mcg/day plus salmeterol 100 mcg/day or (Symbicort) budesonide 320-640 mcg +formoterol 18 mcg/day or (Dulera) mometasone 400-800mcg + formoterol 20 mcg/day. In addition tiotropium 18ucg/day will be used. Additionally, albuterol 0.083%/ipratropium 0.02% solution or MDI HFA for acute exacerbation.Will measure lung function and asthma quality of life questionaire

Primary Outcome Measure

use exhaled nitric oxide as a surrogate marker of large airway vs small airway/lung inflammation following various doses of inhaled corticosteroids [ Time Frame: 20-60 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Arthur F Gelb Medical CorporationLakewoodCalifornia90712
Arthur F Gelb, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lakewood, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Arthur F Gelb Medical Corporation· Lakewood, CA

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