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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 11, 2017
Sponsor:
Information provided by (Responsible Party):
Arthur F Gelb MD, Gelb, Arthur F., M.D.

Tracking Information
First Submitted Date  ICMJE October 19, 2010
First Posted Date  ICMJE October 21, 2010
Last Update Posted Date July 11, 2017
Study Start Date  ICMJE October 2007
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2011)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2010)
  • 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 ]
  • determine site of airflow limitation, whether predominantly large and /or small airways using expiratory flow volume curves obtained before and after asthmatics breathe a 80% helium-20% oxygen gas mixture [ Time Frame: 20-60 days ]
Change History Complete list of historical versions of study NCT01225913 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2012)
  • site/mechanism(s)airflow limitation [ Time Frame: 20-60 days ]
    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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2010)
  • investigate the mechanisms that limit expiratory airflow: intrinsic airway obstruction vs loss of lung elastic recoil [ Time Frame: 20-60 days ]
  • dynamic hyperinflation [ Time Frame: 20-60 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Official Title  ICMJE Evaluation of Mechanism(s)Limiting Expiratory Airflow in Chronic, Stable Asthmatics Who Are Non-smokers
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
    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
Study Arms  ICMJE 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 and additional pharmacologic intervention may include antibiotic and tapering doses of corticosteroids.
Interventions:
  • Drug: budesonide/formoterol or fluticasone/salmeterol in all asthmatics
  • Drug: budesonide/formoterol or fluticasone/salmeterol in all asthmatics
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2014)
50
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2010)
40
Estimated Study Completion Date  ICMJE June 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arthur F Gelb, MD 562-633-2204 afgelb@msn.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01225913
Other Study ID Numbers  ICMJE 20070934A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arthur F Gelb MD, Gelb, Arthur F., M.D.
Study Sponsor  ICMJE Gelb, Arthur F., M.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arthur F Gelb, MD Arthur F Gelb Medical Corporation
PRS Account Gelb, Arthur F., M.D.
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP