AsthmaPhase 4NCT01241006
Single Oral Dose of Dexamethasone Versus Five Days of Prednisone in Adult Asthma
A Phase 4 study testing Dexamethasone and Prednisone in people with Asthma and Reactive Airway Disease, run by Alameda County Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma, Reactive Airway Disease
- What is being tested?
- Dexamethasone and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55yo
- History of asthma
- Requires > 1 albuterol nebulizer
- Valid phone number
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Alameda County Medical Center
Oakland, California, 94602
About this study
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
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.
Read the detailed description
Dexamethasone and Prednisone are both systemic corticosteroids. The study will compare a single dose of oral dexamethasone to 5 days of oral prednisone in the treatment of asthma. Oral corticosteroids are commonly prescribed following an asthma exacerbation as it has been demonstrated that these medications prevent relapse.
Oral prednisone is the most common corticosteroid prescribed for asthma relapse prevention. The half life is around 4 hours and is typically prescribed for minimally 5 days.
The study is evaluating the efficacy of a single dose of dexmethasone. The drug's efficicacy has been shown to be longer acting and up to 72 hours. A single dose would eliminate the need for a prescription for a drug like prednisone to hopefully improve compliance.
- Conditions
- Asthma, Reactive Airway Disease
- Being tested
- Dexamethasone, Prednisone
- Keywords
- Relapse, Corticosteroids
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
Dexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days
PrednisoneDrug
Also called Glucocorticoid
Prednisone 60mg PO q day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Single dose of Dexamethasone 12 mg PO and 4 days of placebo capsules Receives: Drug: Dexamethasone |
| Prednisone | Active comparator | Prednisone 60mg PO capsules for 5 days Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse for worsening asthma within 14 days of ED visit
Relapse will be defined as un unscheduled visit to see a doctor for worsening asthma within 14 days following their ED visit for asthma
Measured: 14-17 days
Secondary outcomes (3)
Compliance
Completion of study medications
Measured: 14 days
Side effects
Assess if any side effects from the study medications
Measured: 14 days
Symptoms persistence or improvement
Assessment of current rescue inhaler use and symptoms such as wheezing, cough, shortness of breath, and difficulty with activities of daily living
Measured: 14-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alameda County Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Rehrer, Alameda County Medical Center
- Investigators
- Barry Simon, MD, Principal investigator, Alameda County Medica Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241006
- Sponsor's protocol ID
- IRB10-08103G
- Status last verified
- Jan 2016
- First submitted
- 15 Nov 2010
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rehrer MW, Liu B, Rodriguez M, Lam J, Alter HJ. A Randomized Controlled Noninferiority Trial of Single Dose of Oral Dexamethasone Versus 5 Days of Oral Prednisone in Acute Adult Asthma. Ann Emerg Med. 2016 Nov;68(5):608-613. doi: 10.1016/j.annemergmed.2016.03.017. Epub 2016 Apr 22.
PubMed 27117874
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01241006
- Acronym / sponsor ID
- IRB10-08103G
- Conditions
- Asthma, Reactive Airway Disease
- Keywords
- Relapse, Corticosteroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Alameda County Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dexamethasone and Prednisone are both systemic corticosteroids. The study will compare a single dose of oral dexamethasone to 5 days of oral prednisone in the treatment of asthma. Oral corticosteroids are commonly prescribed following an asthma exacerbation as it has been demonstrated that these medications prevent relapse.
Oral prednisone is the most common corticosteroid prescribed for asthma relapse prevention. The half life is around 4 hours and is typically prescribed for minimally 5 days.
The study is evaluating the efficacy of a single dose of dexmethasone. The drug's efficicacy has been shown to be longer acting and up to 72 hours. A single dose would eliminate the need for a prescription for a drug like prednisone to hopefully improve compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasoneSingle dose of Dexamethasone 12 mg PO and 4 days of placebo capsules |
| Prednisone | Active comparator | Drug: PrednisonePrednisone 60mg PO capsules for 5 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-55yo
- History of asthma
- Requires > 1 albuterol nebulizer
- Valid phone number
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: DecadronDexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days | Drug | Dexamethasone |
| PrednisoneAlso: GlucocorticoidPrednisone 60mg PO q day for 5 days | Drug | Prednisone |
Primary outcome
Relapse for worsening asthma within 14 days of ED visit
Time frame: 14-17 days
Relapse will be defined as un unscheduled visit to see a doctor for worsening asthma within 14 days following their ED visit for asthma
3 secondary outcomes
Compliance
Time frame: 14 days
Side effects
Time frame: 14 days
Symptoms persistence or improvement
Time frame: 14-21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
- Derived from this study: PubMed 27117874Rehrer MW, Liu B, Rodriguez M, Lam J, Alter HJ. A Randomized Controlled Noninferiority Trial of Single Dose of Oral Dexamethasone Versus 5 Days of Oral Prednisone in Acute Adult Asthma. Ann Emerg Med. 2016 Nov;68(5):608-613. doi: 10.1016/j.annemergmed.2016.03.017. Epub 2016 Apr 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Simon, MD principal investigator
Alameda County Medica Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Prednisone in people with Asthma and Reactive Airway Disease, run by Alameda County Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse for worsening asthma within 14 days of ED visit (time frame: 14-17 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01241006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.