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

ConditionAsthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-95
SponsorGelb, Arthur F., M.D.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Current non-smoking (<10 pack yr smoking history)

Stable, treated asthmatics

Age 12-95 yr

post 180ug albuterol by MDI: FEV 1/FVC < 70% and FEV 1 <80% predicted

Disqualifiers

Pregnancy

Trial population

Chronic Asthmatics

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: asthma, quality of life, lung function4 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

investigate the mechanisms that limit expiratory airflow: intrinsic airway obstruction vs loss of lung elastic recoil

Time frame
20-60 days
4

determine the extent of asthma and distribution of emphysema

at autopsy or post lung transplantation

Time frame
within 10 days following death or explanted lung if lung transplant obtained

Secondary outcomes

1

dynamic hyperinflation

Time frame
20-60 days
2

Evaluate large and small airways and lung parenchyma in autopsied or transplanted lung in asthmatics and look for unsuspected emphysema

If approved by surviving power of attorney, chronic non-smoking asthmatics who expire will undergo autopsy evaluation to evaluate extent of airway obstruction as well as presence of emphysema

Time frame
June 2018
3

Optical Coherence Tomography

When stable, chronic non-smoking asthmatics with persistent expiratory airflow obstruction will undergo OCT via flexible bronchoscopy to detect unsuspected emphysema.

Time frame
June 2015

Other outcomes

Sponsors and contacts

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