AsthmaPhase 3NCT00449501
A Two-week Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects
A Phase 3 study testing Budesonide/formoterol pMDI and Budesonide HFA pMDI in people with Asthma, run by AstraZeneca at 46 sites in United States.
Trial summary
The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose, while receiving SYMBICORT® pMDI 80/4.5 μg x 2 actuations twice daily or budesonide HFA pMDI 80 μg x 2 actuations twice daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide/formoterol pMDI and Budesonide HFA pMDI
- How many people
- 134 participants
- Where
- 46 sitesUnited States
- Study dates
- Mar 2007to Nov 2007
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, > 18 years of age
- Mild to moderate asthma requiring treatment with an inhaled corticosteroid
- Diagnosis of asthma for at least 6 months
Who cannot join
- Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
- Subjects with severe asthma, as judged by investigator
- Any significant disease or disorder that may jeopardize a subject's safety
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Research Site
Akron, Ohio
Research Site
Anaheim, California
Research Site
Avon, Indiana
Research Site
Bay City, Michigan
Research Site
Bend, Oregon
Research Site
Bensalem, Pennsylvania
Research Site
Bismarck, North Dakota
Research Site
Boerne, Texas
Research Site
Brick, New Jersey
Research Site
Charleston, South Carolina
Research Site
Chesterfield, Missouri
Research Site
Dallas, Texas
Research Site
Denver, Colorado
Research Site
East Providence, Rhode Island
Research Site
El Paso, Texas
Research Site
Fargo, North Dakota
Research Site
Feasterville, Pennsylvania
Research Site
Gaffney, South Carolina
Research Site
Greer, South Carolina
Research Site
Iowa City, Iowa
Research Site
Kansas City, Missouri
Research Site
Lake Oswego, Oregon
Research Site
Little Rock, Arkansas
Research Site
Los Angeles, California
Research Site
Mandeville, Louisiana
Research Site
McCook, Nebraska
Research Site
Miami, Florida
Research Site
Muscle Shoals, Alabama
Research Site
North Syracuse, New York
Research Site
Oklahoma City, Oklahoma
Research Site
Palmdale, California
Research Site
Pittsburgh, Pennsylvania
Research Site
Princeton, New Jersey
Research Site
Provo, Utah
Research Site
Rapid City, South Dakota
Research Site
Rolling Hills Estates, California
Research Site
San Antonio, Texas
Research Site
Scottsbluff, Nebraska
Research Site
Shawnee Mission, Kansas
Research Site
Spokane, Washington
Research Site
Stamford, Connecticut
Research Site
Waco, Texas
Research Site
Watertown, South Dakota
Research Site
Wheat Ridge, Colorado
Research Site
Wheaton, Maryland
Research Site
Wilmington, Delaware
About this study
Official title: A Two-week, Randomised, Double-blind Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects (≥ 18 Years) With Mild to Moderate Asthma, Receiving SYMBICORT® pMDI 80/4.5 μg x 2 Actuations Twice Daily or Budesonide HFA pMDI 80 μg x 2 Act. Twice Daily
The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose, while receiving SYMBICORT® pMDI 80/4.5 μg x 2 actuations twice daily or budesonide HFA pMDI 80 μg x 2 actuations twice daily.
- Conditions
- Asthma
- Being tested
- Budesonide/formoterol pMDI, Budesonide HFA pMDI
- Keywords
- Mild Asthma, Moderate Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/formoterol pMDIDrug
Also called Symbicort
Budesonide HFA pMDIDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether subjects respond similarly to the Onset of Effect Questionnaire items 2 and 5 when administered post-dose versus pre-dose and does that difference favour a bronchodilator treatment group over a non-bronchodilator treatment group
Secondary outcomes (1)
To determine if there is an association between the immediate physiological response to medication and the responses to OEQ items 2 and 5 and to determine what subjects mean when they say they feel their asthma maintenance medication 'working right away
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startMar 2007
- Study completionNov 2007
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tomas LG Andersson, MD, Study director, AstraZenenca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449501
- Sponsor's protocol ID
- D5896C00025
- Status last verified
- Jan 2011
- First submitted
- 16 Mar 2007
- Last updated
- 24 Jan 2011
- Results posted
- No
Publications
Leidy NK, Gutierrez B, Lampl K, Uryniak T, O'Brien CD. Can patients with asthma feel inhaler therapy working right away? Two clinical trials testing the effect of timing of assessment on patient perception. J Asthma. 2009 Dec;46(10):1006-12. doi: 10.3109/02770900903301260.
PubMed 19995138
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-week, Randomised, Double-blind Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects (≥ 18 Years) With Mild to Moderate Asthma, Receiving SYMBICORT® pMDI 80/4.5 μg x 2 Actuations Twice Daily or Budesonide HFA pMDI 80 μg x 2 Act. Twice Daily
- ClinicalTrials.gov ID
- NCT00449501
- Acronym / sponsor ID
- D5896C00025
- Conditions
- Asthma
- Keywords
- Mild Asthma, Moderate Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Study completion
- Nov 2007 (actual)
- First posted
- 20 Mar 2007 (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.
The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose, while receiving SYMBICORT® pMDI 80/4.5 μg x 2 actuations twice daily or budesonide HFA pMDI 80 μg x 2 actuations twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female, > 18 years of age
- Mild to moderate asthma requiring treatment with an inhaled corticosteroid
- Diagnosis of asthma for at least 6 months
Key exclusion criteria (3 listed)
- Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
- Subjects with severe asthma, as judged by investigator
- Any significant disease or disorder that may jeopardize a subject's safety
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 |
|---|---|---|
| Budesonide/formoterol pMDIAlso: Symbicort | Drug | – |
| Budesonide HFA pMDI | Drug | – |
Primary outcome
To determine whether subjects respond similarly to the Onset of Effect Questionnaire items 2 and 5 when administered post-dose versus pre-dose and does that difference favour a bronchodilator treatment group over a non-bronchodilator treatment group
1 secondary outcome
To determine if there is an association between the immediate physiological response to medication and the responses to OEQ items 2 and 5 and to determine what subjects mean when they say they feel their asthma maintenance medication 'working right away
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 24 Jan 2011.
- Derived from this study: PubMed 19995138Leidy NK, Gutierrez B, Lampl K, Uryniak T, O'Brien CD. Can patients with asthma feel inhaler therapy working right away? Two clinical trials testing the effect of timing of assessment on patient perception. J Asthma. 2009 Dec;46(10):1006-12. doi: 10.3109/02770900903301260.
- Related InfoLink provided by the sponsor.
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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.
Tomas LG Andersson, MD study director
AstraZenenca
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide/formoterol pMDI and Budesonide HFA pMDI in people with Asthma, run by AstraZeneca at 46 sites 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 3 inclusion and 3 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 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To determine whether subjects respond similarly to the Onset of Effect Questionnaire items 2 and 5 when administered post-dose versus pre-dose and does that difference favour a bronchodilator treatment group over a non-bronchodilator treatment group. 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 NCT00449501, 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 24 Jan 2011.