Mechanism(s) of Airflow Limitation During Exacerbation of Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Gelb, Arthur F., M.D.
Sponsor:
Information provided by (Responsible Party):
Arthur F Gelb MD, Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier:
NCT01225913
First received: October 19, 2010
Last updated: March 1, 2014
Last verified: March 2014
  Purpose

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 Intervention
Asthma
Drug: budesonide/formoterol or fluticasone/salmeterol

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Mechanism(s)Limiting Expiratory Airflow in Chronic, Stable Asthmatics Who Are Non-smokers

Resource links provided by NLM:


Further study details as provided by Gelb, Arthur F., M.D.:

Primary Outcome Measures:
  • Exhaled nitric oxide [ Time Frame: 20-60 days ] [ Designated as safety issue: No ]
    evaluate the role of inhaled corticosteroid on exhaled nitric oxide production in large airways and peripheral small airways/alveoli


Secondary Outcome Measures:
  • site/mechanism(s)airflow limitation [ Time Frame: 20-60 days ] [ Designated as safety issue: No ]
    evaluate the site of expiratory airflow limitation ie. small versus large airways and mechanism(s) of expiratory airflow limitation whether intrinsic airway obstruction versus loss of lung elastic recoil

  • dynamic hyperinflation [ Time Frame: 20-60 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2007
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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 with no pharmacologic intervention.
Drug: budesonide/formoterol or fluticasone/salmeterol
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
Drug: budesonide/formoterol or fluticasone/salmeterol
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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225913

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

Locations
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.
Investigators
Principal Investigator: Arthur F Gelb, MD Arthur F Gelb Medical Corporation
  More Information

Publications:

Responsible Party: Arthur F Gelb MD, Principal Investigator, Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier: NCT01225913     History of Changes
Obsolete Identifiers: NCT01225900
Other Study ID Numbers: 20070934A
Study First Received: October 19, 2010
Last Updated: March 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Gelb, Arthur F., M.D.:
asthma
lung function
inflammation

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Budesonide
Formoterol
Salmeterol
Albuterol
Symbicort
Fluticasone, salmeterol drug combination
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on September 22, 2014