AsthmaPhase 3BAINCT01360021

New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day

A Phase 3 study testing Symbicort and Budesonide in people with Asthma, run by AstraZeneca at 41 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Asthma
What is being tested?: Symbicort and Budesonide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 214 participants
Where: 41 sitesin 4 countries
Study dates: Nov 2011to Aug 2012
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 12 years and above
Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months
Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal
Patients with reversible airway obstruction
Documented daily use of inhaled corticosteroids for ≥ 3 months

Who cannot join

History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2
Hospitalized during previous 6 months for asthma
Required emergency treatment more than once during previous 6 months for an asthma-related condition
Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment
Respiratory infection affecting the asthma within 30 days

Trial locations and contacts

41 sites in 4 countries.

Country

City, postcode or hospital

41 sites in 4 countries

United States31 sites

Research Site
Bangor, Maine
Research Site
Charleston, South Carolina
Research Site
Cincinnati, Ohio
Research Site
Collegeville, Pennsylvania
Research Site
Columbia, Missouri
Research Site
Dallas, Texas
Research Site
Greenfield, Wisconsin
Research Site
Huntington Beach, California
Research Site
Lincoln, Rhode Island
Research Site
Long Beach, California
Research Site
Los Angeles, California
Research Site
Louisville, Kentucky
Research Site
Madison, Wisconsin
Research Site
Metairie, Louisiana
Research Site
North Dartmouth, Massachusetts
Research Site
North Syracuse, New York
Research Site
Orange, California
Research Site
Rancho Mirage, California
Research Site
River Forest, Illinois
Research Site
Riverside, California
Research Site
Rochester, New York
Research Site
Rolla, Missouri
Research Site
Sacramento, California
Research Site
San Diego, California
Research Site
San Jose, California
Research Site
Savannah, Georgia
Research Site
Skillman, New Jersey
Research Site
Spartanburg, South Carolina
Research Site
Tacoma, Washington
Research Site
Tallahassee, Florida
Research Site
Wheaton, Maryland

Other trials in United States

Bulgaria4 sites

Research Site
Rousse, Bulgaria
Research Site
Sevlievo, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria

Other trials in Bulgaria

Hungary4 sites

Research Site
Balassagyarmat, Hungary
Research Site
Budapest, Hungary
Research Site
Salgótarján, Hungary
Research Site
Százhalombatta, Hungary

Other trials in Hungary

Russia2 sites

Research Site
Moscow, Russia
Research Site
Yekaterinburg, Russia

Other trials in Russia

About this study

Official title: A 12-week, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy Safety, and Patient Use (User Study) of Symbicort® (Budesonide/Formoterol) Breath Actuated Metered Dose Inhaler (BA MDI) 2x160/4.5 μg Twice Daily Compared With Symbicort (Budesonide/Formoterol) AC (Actuation Counter) pMDI® 2x160/4.5 μg Twice Daily and Budesonide AC pMDI 2x160 μg Twice Daily in Adult and Adolescent Asthmatics

This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.

Conditions: Asthma
Being tested: Symbicort, Budesonide
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SymbicortDrug
Breath actuated metered dose inhaler
SymbicortDrug
Actuation counter pressured metered dose inhaler
BudesonideDrug
Actuation counter pressured metered dose inhaler

Study groups in NCT01360021
Study group	Role	What they receive
1 Symbicort/inhaler	Active comparator	Symbicort BA MDI 2x160/4.5 μg twice daily Receives: Drug: Symbicort
Symbicort/inhaler	Active comparator	Symbicort AC pDMI 2x160/4.5 μg twice daily Receives: Drug: Symbicort
Budesonide/inhaler	Active comparator	Budesonide AC pMDI 2x160 μg twice daily Receives: Drug: Budesonide

What is being measured

The primary outcome is the main question the study is designed to answer.

Forced Expiratory Volume in 1 Second (FEV1) - Post Dose
Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
Measured: 60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg
Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose
Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
Measured: Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg

Secondary outcomes (4)

Peak Expiratory Flow
Measured: Recorded morning upon rising and evening before sleep for 14 weeks
Asthma Symptoms Score (Total)
The total score is calculated as sum of the morning and evening scores of each day and the treatment period mean score is defined as the mean of all total score recorded during the 12-week treatment period. Trt Avg=Mean total score of double-blind period values.(day/night score ranges from 0 to 3; 0=no asthma symptoms; 3= unable to do normal activities (or to sleep) due to asthma). Higher score represents worse outcome.
Measured: Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks
Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)
The percentage of days with no awakenings due to asthma. Baseline= Mean % awakening-free nights during run-in period ; Trt Avg=Mean % awakening-free nights during double-blind period.
Measured: Recorded 6:00 - 11:00 AM for 14 weeks
Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)
Total daily rescue medication use is calculated as the sum of morning and evening use each day and averaged over the 12 weeks treatment periods to calculate the treatment period mean. Baseline= Mean rescue medication used during run-in period ; Trt Avg=Mean rescue medication used during double-blind period.
Measured: Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Aug 2012

First posted25 May 2011 (estimated)
Study startNov 2011
Primary completionAug 2012
Study completionAug 2012

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 (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: 214 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01360021
Sponsor's protocol ID: D589OC00003
Acronym: BAI
Status last verified: Jan 2014
First submitted: 19 May 2011
Last updated: 11 Mar 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Murphy KR, Dhand R, Trudo F, Uryniak T, Aggarwal A, Eckerwall G. Therapeutic equivalence of budesonide/formoterol delivered via breath-actuated inhaler vs pMDI. Respir Med. 2015 Feb;109(2):170-9. doi: 10.1016/j.rmed.2014.12.009. Epub 2015 Jan 3.
PubMed 25596138

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-week, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy Safety, and Patient Use (User Study) of Symbicort® (Budesonide/Formoterol) Breath Actuated Metered Dose Inhaler (BA MDI) 2x160/4.5 μg Twice Daily Compared With Symbicort (Budesonide/Formoterol) AC (Actuation Counter) pMDI® 2x160/4.5 μg Twice Daily and Budesonide AC pMDI 2x160 μg Twice Daily in Adult and Adolescent Asthmatics
ClinicalTrials.gov ID: NCT01360021
Acronym / sponsor ID: BAI / D589OC00003
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 214 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 25 May 2011 (estimated)
Results: Posted 11 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
1 Symbicort/inhaler	Active comparator	Drug: SymbicortSymbicort BA MDI 2x160/4.5 μg twice daily
Symbicort/inhaler	Active comparator	Drug: SymbicortSymbicort AC pDMI 2x160/4.5 μg twice daily
Budesonide/inhaler	Active comparator	Drug: BudesonideBudesonide AC pMDI 2x160 μg 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 (5 listed)

Male or female 12 years and above
Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months
Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal
Patients with reversible airway obstruction
Documented daily use of inhaled corticosteroids for ≥ 3 months

Key exclusion criteria (5 listed)

History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2
Hospitalized during previous 6 months for asthma
Required emergency treatment more than once during previous 6 months for an asthma-related condition
Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment
Respiratory infection affecting the asthma within 30 days

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
SymbicortBreath actuated metered dose inhaler	Drug	1 Symbicort/inhaler
SymbicortActuation counter pressured metered dose inhaler	Drug	Symbicort/inhaler
BudesonideActuation counter pressured metered dose inhaler	Drug	Budesonide/inhaler

Primary outcome

Forced Expiratory Volume in 1 Second (FEV1) - Post Dose
Time frame: 60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg
Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose
Time frame: Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg
Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.

4 secondary outcomes

Peak Expiratory Flow
Time frame: Recorded morning upon rising and evening before sleep for 14 weeks
Asthma Symptoms Score (Total)
Time frame: Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks
Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)
Time frame: Recorded 6:00 - 11:00 AM for 14 weeks
Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)
Time frame: Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks

Results and safety

Results posted to the registry on 11 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symbicort BA MDI	71	63
Symbicort pMDI	71	67
Budesonide	72	65

Primary outcome: Forced Expiratory Volume in 1 Second (FEV1) - Post Dose

Time frame: 60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg. Geometric mean (Geometric Coefficient of Variation). Unit: Liter

Measure	Symbicort BA MDI n = 71	Symbicort pMDI n = 71	Budesonide n = 71
Baseline	2.09 (31.46)	1.97 (27.16)	2.12 (26.34)
Week 0	2.49 (32.14)	2.35 (25.97)	2.28 (27.18)
Week 3	2.52 (31.98)	2.34 (26.31)	2.30 (30.22)
Week 7	2.59 (32.17)	2.35 (27.22)	2.33 (29.29)
Week 12	2.52 (30.71)	2.39 (27.31)	2.30 (28.27)
Treatment Average	2.53 (30.57)	2.37 (26.33)	2.30 (28.36)

Symbicort pMDI vs Budesonide: Estimated Geometic Mean Ratio: 1.10 (95% CI 1.06 to 1.14), p = 0.001, ANCOVA
Symbicort BA MDI vs Symbicort pMDI: Estimated Geometric Mean Ratio: 1.01 (95% CI 0.97 to 1.05), ANCOVA

Population analysed: Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).

Primary outcome: Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose

Time frame: Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg. Geometric mean (Geometric Coefficient of Variation). Unit: Liters

Measure	Symbicort BA MDI n = 71	Symbicort pMDI n = 71	Budesonide n = 71
Baseline	2.09 (31.46)	1.97 (27.16)	2.12 (26.34)
Week 3	2.32 (32.79)	2.12 (28.29)	2.22 (31.21)
Week 7	2.40 (32.86)	2.11 (29.96)	2.25 (29.01)
Week 12	2.34 (30.84)	2.17 (31.29)	2.23 (30.15)
Average of treatment period	2.34 (30.15)	2.15 (29.15)	2.23 (29.36)

Symbicort BA MDI vs Symbicort pMDI: Estimated Geometric Mean Ratio: 1.03 (95% CI 0.99 to 1.08), ANCOVA

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Budesonide	0 of 71 (0%)	3 of 71 (4.2%)	Not reported
Symbicort BA MDI	0 of 71 (0%)	2 of 71 (2.8%)	Not reported
Symbicort pMDI	1 of 71 (1.4%)	7 of 71 (9.9%)	Not reported

Limitations and caveats (from the sponsor): No. of participants in the safety analysis set is (71 for all the group) as 1 patients from the Budesonide group has not taken any dose of the IP, so not included in the Safety population.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25596138Murphy KR, Dhand R, Trudo F, Uryniak T, Aggarwal A, Eckerwall G. Therapeutic equivalence of budesonide/formoterol delivered via breath-actuated inhaler vs pMDI. Respir Med. 2015 Feb;109(2):170-9. doi: 10.1016/j.rmed.2014.12.009. Epub 2015 Jan 3.

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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.

Goran Eckerwall, MD study director

AstraZeneca R&D, Mölndal

41 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Symbicort and Budesonide in people with Asthma, run by AstraZeneca at 41 sites in 4 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 5 inclusion and 5 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 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Bulgaria, Hungary, Russia. 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 11 Mar 2014). 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?

Forced Expiratory Volume in 1 Second (FEV1) - Post Dose (time frame: 60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg). The study lists 2 primary outcomes in all. 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 NCT01360021, 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 11 Mar 2014.