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Corticosteroid

Inhaled Steroids/Long-Acting Bronchodilators for Asthma

Phase 4

Recruiting

Led By Arthur F Gelb, MD

Research Sponsored by Gelb, Arthur F., M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 10-80 yr

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is looking at the different sites and causes of airflow limitation in asthmatics, and whether certain treatments can help.

Who is the study for?

This trial is for stable, treated asthmatics aged 10-80 who are current non-smokers with a minimal smoking history. Participants should have specific levels of lung function reduction after using albuterol. Pregnant individuals cannot participate.

What is being tested?

The study tests the effects of two inhaled treatments: budesonide/formoterol and fluticasone/salmeterol on airflow limitation in asthma patients. It aims to identify which airways are affected and how inflammation can be reduced using different doses.

What are the potential side effects?

Possible side effects include throat irritation, hoarseness, coughing, headaches, and an increased risk of infections due to the suppression of immune responses in the airways by corticosteroids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 10 and 80 years old.

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My lung function tests show severe asthma or COPD.

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I currently do not smoke and have smoked less than 10 pack-years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Exhaled nitric oxide

Secondary study objectives

Mechanism(s) of expiratory airflow limitation

Presence of unsuspected emphysema by autopsy or explanted lung

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Asthma observational study armExperimental Treatment2 Interventions

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.

0 / 3Eligibility criteria met