AsthmaPhase 3NCT00419757
An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma
A Phase 3 study testing Budesonide/formoterol (SYMBICORT) pMDI and Budesonide HFA pMDI in people with Asthma, run by AstraZeneca at 39 sites in 2 countries.
Trial summary
The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide/formoterol (SYMBICORT) pMDI and Budesonide HFA pMDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 39 sitesin 2 countries
- Study dates
- Jan 2007to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or Female, Hispanic (self-reported), > 12 years of age
- Moderate to severe 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)
- Any significant disease or disorder that may jeopardize a subject's safety
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
United States32 sites
Research Site
Anaheim, California
Research Site
Boerne, Texas
Research Site
Chicago, Illinois
Research Site
Chula Vista, California
Research Site
El Paso, Texas
Research Site
Fort Worth, Texas
Research Site
Fresno, California
Research Site
Fullerton, California
Research Site
Houston, Texas
Research Site
Largo, Florida
Research Site
Los Angeles, California
Research Site
Miami, Florida
Research Site
Naranja, Florida
Research Site
National City, California
Research Site
Newburgh, New York
Research Site
North Miami, Florida
Research Site
Oklahoma City, Oklahoma
Research Site
Orlando, Florida
Research Site
Panama City, Florida
Research Site
Philadelphia, Pennsylvania
Research Site
Pueblo, Colorado
Research Site
Rancho Cordova, California
Research Site
Rancho Mirage, California
Research Site
Riverside, California
Research Site
Sacramento, California
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
San Francisco, California
Research Site
South Miami, Florida
Research Site
Spring, Texas
Research Site
Stockton, California
Research Site
Torrance, California
Puerto Rico7 sites
Research Site
Aguas Buenas
Research Site
Caquas
Research Site
Cidra
Research Site
Levittown
Research Site
Ponce
Research Site
SanJuan
Research Site
Trujillo Alto
About this study
Official title: A 12-week, Randomised, Double Blind, Active-controlled, Multi-centre, Phase IIIB Study Comparing the Efficacy and Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily Versus Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily, in Adult/Adolescent (> 12 Yrs) Hispanic Subjects With Asthma
The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.
- Conditions
- Asthma
- Being tested
- Budesonide/formoterol (SYMBICORT) pMDI, Budesonide HFA pMDI
- Keywords
- Moderate asthma, Severe 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 (SYMBICORT) pMDIDrug
SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
Budesonide HFA pMDIDrug
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
| Study group | Role | What they receive |
|---|---|---|
| Symbicort | Active comparator | SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily Receives: Drug: Budesonide/formoterol (SYMBICORT) pMDI |
| Budesonide | Active comparator | budesonide HFA pMDI 160 μg x 2 actuations twice daily Receives: Drug: Budesonide HFA pMDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morning Peak Expiratory Flow (AM PEF)
Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.
Measured: Baseline (run-in) and throughout 12 weeks
Secondary outcomes (15)
Percentage of Participants With Pre-defined Asthma Events
Asthma Events, defined as any of: decrease in lung function (FEV1 or AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring use of rescue medication, exacerbation of asthma requiring medical assistance, use of not allowed asthma medication
Measured: 12 weeks
Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events"
Percentage of participants with "Withdrawals Due to Pre-defined Asthma Events" as recorded in CRF. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Measured: 12 weeks
Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Changes in pre-dose FEV1 from baseline to the average value over the treatment period, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Measured: Baseline, 2, 6 and 12 weeks
Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)
Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks with baseline as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Measured: Baseline (run-in) and throughout 12 weeks
Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks
Change from baseline in average of daily scores for nighttime asthma over 12 weeks of treatment, with baseline value as covariate.
Daily scale:
- 0 = No symptoms
- 1 = Mild symptoms
- 2 = Moderate symptoms
- 3 = Severe symptoms
Measured: Baseline (run-in) and throughout 12 weeks
Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks
Change from baseline in average of daily scores for daytime asthma over 12 weeks of treatment, with baseline value as covariate.
Daily scale:
- 0 = No symptoms
- 1 = Mild symptoms
- 2 = Moderate symptoms
- 3 = Severe symptoms
Measured: Baseline (run-in) and throughout 12 weeks
Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks
Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.
Measured: Baseline (run-in) and throughout 12 weeks
Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment
Change from baseline in rescue medication use over 12 weeks of treatment with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Measured: Baseline (run-in) and throughout 12 weeks
Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment
Change from baseline in percentage of rescue-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Measured: Baseline (run-in) and throughout 12 weeks
Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment
Change from baseline in percentage of symptom-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Measured: Baseline (run-in) and throughout 12 weeks
Subject Global Assessment
The assessment was made using a 5-point Likert scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1 and 2 combined as "Yes" and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.
Measured: Baseline and week 12
Physician Global Assessment
The assessment was made using a 5-point scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1and 2 combined as "Yes" and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.
Measured: Baseline and week 12
Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index
Mean scores (6-points scale, where 1-means the most positive opinion and 6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.
Measured: Week 12
Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication
Mean scores (6 or 5-points scale, where 1-means the most positive opinion and 5/6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.
Measured: Week 12
Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications
Mean scores (5-points scale, where 1-means the most positive opinion and 5-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christer Hultquist, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419757
- Sponsor's protocol ID
- D5896C00021
- Status last verified
- Aug 2012
- First submitted
- 5 Jan 2007
- Last updated
- 27 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000.
PubMed 22329608Zangrilli J, Mansfield LE, Uryniak T, O'Brien CD. Efficacy of budesonide/formoterol pressurized metered-dose inhaler versus budesonide pressurized metered-dose inhaler alone in Hispanic adults and adolescents with asthma: a randomized, controlled trial. Ann Allergy Asthma Immunol. 2011 Sep;107(3):258-65.e2. doi: 10.1016/j.anai.2011.05.024. Epub 2011 Jul 14.
PubMed 21875546
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Randomised, Double Blind, Active-controlled, Multi-centre, Phase IIIB Study Comparing the Efficacy and Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily Versus Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily, in Adult/Adolescent (> 12 Yrs) Hispanic Subjects With Asthma
- ClinicalTrials.gov ID
- NCT00419757
- Acronym / sponsor ID
- D5896C00021
- Conditions
- Asthma
- Keywords
- Moderate asthma, Severe asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 9 Jan 2007 (estimated)
- Results
- Posted 27 Aug 2012
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 determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.
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 |
|---|---|---|
| Symbicort | Active comparator | Drug: Budesonide/formoterol (SYMBICORT) pMDISYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily |
| Budesonide | Active comparator | Drug: Budesonide HFA pMDIbudesonide HFA pMDI 160 μg x 2 actuations twice daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female, Hispanic (self-reported), > 12 years of age
- Moderate to severe asthma requiring treatment with an inhaled corticosteroid
- Diagnosis of asthma for at least 6 months
Key exclusion criteria (2 listed)
- Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
- 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 (SYMBICORT) pMDISYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily | Drug | Symbicort |
| Budesonide HFA pMDIBudesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily | Drug | Budesonide |
Primary outcome
Morning Peak Expiratory Flow (AM PEF)
Time frame: Baseline (run-in) and throughout 12 weeks
Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.
15 secondary outcomes
Percentage of Participants With Pre-defined Asthma Events
Time frame: 12 weeks
Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events"
Time frame: 12 weeks
Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, 2, 6 and 12 weeks
Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)
Time frame: Baseline (run-in) and throughout 12 weeks
Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks
Time frame: Baseline (run-in) and throughout 12 weeks
Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks
Time frame: Baseline (run-in) and throughout 12 weeks
Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks
Time frame: Baseline (run-in) and throughout 12 weeks
Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment
Time frame: Baseline (run-in) and throughout 12 weeks
Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment
Time frame: Baseline (run-in) and throughout 12 weeks
Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment
Time frame: Baseline (run-in) and throughout 12 weeks
Subject Global Assessment
Time frame: Baseline and week 12
Physician Global Assessment
Time frame: Baseline and week 12
Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index
Time frame: Week 12
Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication
Time frame: Week 12
Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22329608Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000.
- Derived from this study: PubMed 21875546Zangrilli J, Mansfield LE, Uryniak T, O'Brien CD. Efficacy of budesonide/formoterol pressurized metered-dose inhaler versus budesonide pressurized metered-dose inhaler alone in Hispanic adults and adolescents with asthma: a randomized, controlled trial. Ann Allergy Asthma Immunol. 2011 Sep;107(3):258-65.e2. doi: 10.1016/j.anai.2011.05.024. Epub 2011 Jul 14.
- Related InfoLink provided by the sponsor.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Christer Hultquist, MD study director
AstraZeneca
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide/formoterol (SYMBICORT) pMDI and Budesonide HFA pMDI in people with Asthma, run by AstraZeneca at 39 sites in 2 countries.
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 2 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 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Puerto Rico. 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?
Yes. Results are posted in the registry (first posted 27 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Morning Peak Expiratory Flow (AM PEF) (time frame: Baseline (run-in) and throughout 12 weeks). 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 NCT00419757, which also lists 2 linked publications.
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 27 Aug 2012.