A Randomized Double-Blind Controlled Trial of Single Oral Dose Dexamethasone Versus Five Days of Oral Prednisone in Acute Mild to Moderate Adult Asthma
This study is currently recruiting participants.
Verified January 2012 by Alameda County Medical Center
Sponsor:
Alameda County Medical Center
Information provided by (Responsible Party):
Matthew Rehrer, Alameda County Medical Center
ClinicalTrials.gov Identifier:
NCT01241006
First received: November 15, 2010
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
This study seeks to compare the effectiveness of a single dose of oral dexamethasone versus 5 days of oral prednisone in the treatment of mild to moderate asthma exacerbations to prevent relapse with an unscheduled return visit to a health care provider for additional asthma treatment within 14 days. The investigators hypothesize that the two treatments will be equally effective in relapse prevention.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma Reactive Airway Disease |
Drug: Dexamethasone Drug: Prednisone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Double-Blind Controlled Trial of Single Oral Dose Dexamethasone Versus Five Days of Oral Prednisone in Acute Mild to Moderate Adult Asthma |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Prednisone
Dexamethasone acetate
Dexamethasone sodium phosphate
U.S. FDA Resources
Further study details as provided by Alameda County Medical Center:
Primary Outcome Measures:
- Relapse for worsening asthma within 14 days of ED visit [ Time Frame: 14-17 days ] [ Designated as safety issue: No ]Relapse will be defined as un unscheduled visit to see a doctor for worsening asthma within 14 days following their ED visit for asthma
Secondary Outcome Measures:
- Compliance [ Time Frame: 14 days ] [ Designated as safety issue: No ]Completion of study medications
- Side effects [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]Assess if any side effects from the study medications
- Symptoms persistence or improvement [ Time Frame: 14-21 days ] [ Designated as safety issue: No ]Assessment of current rescue inhaler use and symptoms such as wheezing, cough, shortness of breath, and difficulty with activities of daily living
| Estimated Enrollment: | 370 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Dexamethasone
Single dose of Dexamethasone 12 mg PO and 4 days of placebo capsules
|
Drug: Dexamethasone
Dexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days
|
|
Active Comparator: Prednisone
Prednisone 60mg PO capsules for 5 days
|
Drug: Prednisone
Prednisone 60mg PO q day for 5 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18-55yo
- History of asthma
- Requires > 1 albuterol nebulizer
- Valid phone number
Exclusion Criteria:
- declines participation
- Past allergic reaction to corticosteroids
- Use of Oral steroids in the last 2 weeks
- Pregnant
- History of COPD, pulmonary fibrosis, cystic fibrosis, or other chronic lung disease
- History of HIV
- History of CHF
- History of Diabetes mellitus
- Active chickenpox (varicella) or shingles (herpes zoster)
- Active TB
- Requires admission to the Hospital
- Requires immediate airway intervention
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241006
Contacts
| Contact: Matthew Rehrer, MD | 510-437-4564 | matthewrehrer@gmail.com |
Locations
| United States, California | |
| Alameda County Medical Center | Recruiting |
| Oakland, California, United States, 94602 | |
| Contact: Matthew Rehrer, MD 510-437-4564 matthewrehrer@gmail.com | |
Sponsors and Collaborators
Alameda County Medical Center
Investigators
| Principal Investigator: | Barry Simon, MD | Alameda County Medica Center |
More Information
No publications provided
| Responsible Party: | Matthew Rehrer, Chairman of ACMC Emergency Department, Alameda County Medical Center |
| ClinicalTrials.gov Identifier: | NCT01241006 History of Changes |
| Other Study ID Numbers: | IRB10-08103G |
| Study First Received: | November 15, 2010 |
| Last Updated: | January 31, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Alameda County Medical Center:
|
Relapse Corticosteroids |
Additional relevant MeSH terms:
|
Asthma Bronchial Hyperreactivity Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Dexamethasone acetate Dexamethasone Prednisone Dexamethasone 21-phosphate BB 1101 |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on June 13, 2013