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NCT Number: NCT01225913

Mechanism(s) of Airflow Limitation During Exacerbation of Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arthur F Gelb Medical Corporation

Lakewood, California, 90712, United States

Location status: Recruiting

Location contact

Arthur F Gelb, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluticasone/salmeterol in all asthmatics

Drug

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

budesonide/formoterol or fluticasone/salmeterol in all asthmatics

Drug

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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Arthur F Gelb, MD

CONTACT

[email protected]

562-633-2204

Sponsors and collaborators

Lead sponsor

Gelb, Arthur F., M.D.

Indiv

Registry information

Official study title

Evaluation of Mechanism(s)Limiting Expiratory Airflow in Chronic, Stable Asthmatics Who Are Non-smokers

Important dates

Study start
2007
Primary completion
2027
Study completion
2027
First posted
Oct 21, 2010
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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