Mechanism(s) of Airflow Limitation During Exacerbation of Asthma

ConditionAsthma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age10-80
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. 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

  • 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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Asthma observational study armOther 2 interventions

Trial outcomes

Primary outcomes

1

Exhaled nitric oxide

evaluate the role of inhaled corticosteroid on exhaled nitric oxide production in large airways and peripheral small airways/alveoli

Time frame
20-60 days

Secondary outcomes

1

Mechanism(s) of expiratory airflow limitation

loss of lung elastic recoil vs intrinsic airway obstruction

Time frame
1 to 5 years
2

Presence of unsuspected emphysema by autopsy or explanted lung

Analysis of lungs obtained at autopsy or explanted lung for extent of emphysema

Time frame
1-5 years

Other outcomes

Sponsors and contacts

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