Repeated High-dose Inhaled Corticosteroids for Asthma

NCT00695604 | Withdrawn Phase 2 DMC

• 1 other identifier: 15322B
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

Acute asthma; fluticasone; inhaled corticosteroids

Outcome Measures

Primary Outcomes (1)

• Airflow inflammation.

  Pre-study and post-study drug administration

Secondary Outcomes (1)

• Airflow obstruction.

  Pre-study and post-study drug administration

Study Arms (2)

1

PLACEBO COMPARATOR

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

Drug: Placebo

2

ACTIVE COMPARATOR

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

Drug: Fluticasone

Interventions

Placebo DRUG

Placebo via MDI.

1

Fluticasone DRUG

Fluticasone MDI.

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jerry Krishnan, MD, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

US (1)