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Mechanism(s) of Airflow Limitation During Exacerbation of Asthma

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ClinicalTrials.gov Identifier: NCT01225913
Recruitment Status : Recruiting
First Posted : October 21, 2010
Last Update Posted : July 29, 2020
Information provided by (Responsible Party):
Arthur F Gelb MD, Gelb, Arthur F., M.D.

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: fluticasone/salmeterol in all asthmatics Drug: budesonide/formoterol or fluticasone/salmeterol in all asthmatics Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: To Better Understand the Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Mechanism(s)Limiting Expiratory Airflow in Chronic, Stable Asthmatics Who Are Non-smokers
Study Start Date : October 2007
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Asthma observational study arm
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
budesonide 80ug/formoterol 4.5ug, 2 inhalations bid X 20-60 days or fluticasone 100ug/salmeterol 50ug, 1 inhalation bid X 20-60 days
Other Names:
  • symbicort 80/4.5
  • advair 100/50 or 250/50 or 500/50 bid

Drug: budesonide/formoterol or fluticasone/salmeterol in all asthmatics
budesonide 160ug/formoterol 4.5ug, 2 inhalations bid or fluticasone 250ug/salmeterol 50ug, 1 inhalations bid
Other Names:
  • symbicort 160/4.5
  • advair 250/50

Primary Outcome Measures :
  1. Exhaled nitric oxide [ Time Frame: 20-60 days ]
    evaluate the role of inhaled corticosteroid on exhaled nitric oxide production in large airways and peripheral small airways/alveoli

Secondary Outcome Measures :
  1. Mechanism(s) of expiratory airflow limitation [ Time Frame: 1 to 5 years ]
    loss of lung elastic recoil vs intrinsic airway obstruction

  2. Presence of unsuspected emphysema by autopsy or explanted lung [ Time Frame: 1-5 years ]
    Analysis of lungs obtained at autopsy or explanted lung for extent of emphysema

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225913

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Contact: Arthur F Gelb, MD 562-633-2204 afgelb@msn.com

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United States, California
Arthur F Gelb Medical Corporation Recruiting
Lakewood, California, United States, 90712
Principal Investigator: Arthur F Gelb, MD         
Sponsors and Collaborators
Gelb, Arthur F., M.D.
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Principal Investigator: Arthur F Gelb, MD Arthur F Gelb Medical Corporation
Publications of Results:

Other Publications:

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Responsible Party: Arthur F Gelb MD, Principal Investigator, Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier: NCT01225913    
Obsolete Identifiers: NCT01225900
Other Study ID Numbers: 20070934A
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Arthur F Gelb MD, Gelb, Arthur F., M.D.:
lung function
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists