Repeated High-dose Inhaled Corticosteroids for Asthma (ReHICS)

The University of Chicago

Status and phase: Withdrawn; Phase 2

Conditions: Asthma

Treatments: Drug: Fluticasone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00695604

15322B

Details and patient eligibility

About

The purpose of this study is to to compare the effects of high-dose Inhaled Corticosteroids (ICS) vs. placebo in adults with chronic stable asthma.

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physician diagnosis of asthma.

• Age ≥18 years and ≤50 years

• Evidence of airflow obstruction as measured by spirometry and flow-volume loop per American Thoracic Society guidelines.

• Treatment for asthma with:

  • daily inhaled corticosteroids and long-acting beta2-agonists, AND
  • as-needed use of a short-acting beta2-agonist

Exclusion criteria

• History of >10 pack-year tobacco use
• Other pulmonary or cardiac diagnosis that is actively being treated
• History of adverse events or allergy to fluticasone
• Systemic corticosteroid therapy within 7 days of study visit
• Inability to obtain written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo Comparator All patients assigned to this group will receive: 1. Placebo via Metered Dose Inhaler (MDI). 2. Albuterol via MDI.

Treatment:

Drug: Placebo

2

Active Comparator group

Description:

Active Comparator All patients assigned to this group will receive: 1. Fluticasone via MDI. 2. Albuterol via MDI.

Treatment:

Drug: Fluticasone