AsthmaPhase 3SpacerNCT00536913

Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma

A Phase 3 study testing Budesonide/formoterol pMDI 40/2.25ug + spacer and Budesonide/formoterol pMDI 40/2.25 ug in people with Asthma, run by AstraZeneca at 11 sites in 3 countries.

Completed

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

Official record

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Trial summary

The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years). Read more about this study

Who is it for?: Ages 6 to 11 years
Conditions the study is for: Asthma
What is being tested?: Budesonide/formoterol pMDI 40/2.25ug + spacer and Budesonide/formoterol pMDI 40/2.25 ug
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 11 sitesin 3 countries
Study dates: Sep 2007to Feb 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 6 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

children 6-11 years, diagnosed asthma treated
6 months, PEF
50% of predicted normal value pre-bronchodilator

Who cannot join

current systemic glucocorticosteroids usage
current respiratory infection
any significant disease or disorder as judged by investigator

Trial locations and contacts

11 sites in 3 countries.

Country

City, postcode or hospital

11 sites in 3 countries

Poland7 sites

Research Site
Bialystok
Research Site
Bydgoszcz
Research Site
Bytom
Research Site
Karpacz
Research Site
Krakow
Research Site
Lodz
Research Site
Warsaw

Other trials in Poland

Hungary3 sites

Research Site
Budapest
Research Site
Debrecen
Research Site
Kaposvár

Other trials in Hungary

Russia1 site

Research Site
Moscow

Other trials in Russia

About this study

Official title: A 4-week, Open-label, Randomized, Multi-centre, Parallel-group Study Evaluating the Safety and Efficacy of 4 Actuations Symbicort® (Budesonide/Formoterol) HFA pMDI 40/2.25 μg Twice Daily, With and Without Spacer, in Children (6-11 Years) With Asthma

The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years).

Conditions: Asthma
Being tested: Budesonide/formoterol pMDI 40/2.25ug + spacer, Budesonide/formoterol pMDI 40/2.25 ug
Keywords: Symbicort pMDI, spacer, children
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 pMDI 40/2.25ug + spacerDrug
Budesonide/formoterol pMDI 40/2.25 ugDrug

Study groups in NCT00536913
Study group	Role	What they receive
With Spacer	Experimental	Budesonide/formoterol pMDI 40/2.25ug + spacer Receives: Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer	Experimental	Budesonide/formoterol pMDI 40/2.25 ug Receives: Drug: Budesonide/formoterol pMDI 40/2.25 ug

What is being measured

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

Urinary Free Cortisol (UFC)
Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment
Measured: At baseline and 4 weeks

Secondary outcomes (8)

Forced Expiratory Volume in 1 Second (FEV1)
Changes in FEV1 from baseline to the mean value at 2 weeks to 4 weeks with the baseline value as a covariate.
Measured: At baseline, at 2 weeks and 4 weeks
Morning Peak Expiratory Flow (mPEF)
Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry were estimated using linear interpolation.
Measured: Daily during run-in and daily during treatment period of 6 weeks
Evening Peak Expiratory Flow (ePEF)
Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation. Missing data between the first and last entry were estimated using linear interpolation.
Measured: Daily during run-in and daily during treatment period of 6 weeks
Asthma Symptoms at Night
Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.
Measured: Daily during run-in and daily during treatment period of 6 weeks
Asthma Symptoms at Day
Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.
Measured: Daily during run-in and daily during treatment period of 6 weeks
Percentage of Nights With Awakenings Due to Asthma
Change in Percentage of nights with awakenings, average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.
Measured: Daily during run-in and daily during treatment period of 6 weeks
Use of Rescue Medication at Night
Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.
Measured: Daily during run-in and daily during treatment period of 6 weeks
Use of Rescue Medication at Day
Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.
Measured: Daily during run-in and daily during treatment period of 6 weeks

Timeline

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

Sep 2007Feb 2008

First posted28 Sep 2007 (estimated)
Study startSep 2007
Primary completionFeb 2008
Study completionFeb 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.
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: None (open label)
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00536913
Sponsor's protocol ID: D5897C00004
Acronym: Spacer
Status last verified: Apr 2012
First submitted: 26 Sep 2007
Last updated: 6 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

RecruitingPhase 1
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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
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RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
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RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4-week, Open-label, Randomized, Multi-centre, Parallel-group Study Evaluating the Safety and Efficacy of 4 Actuations Symbicort® (Budesonide/Formoterol) HFA pMDI 40/2.25 μg Twice Daily, With and Without Spacer, in Children (6-11 Years) With Asthma
ClinicalTrials.gov ID: NCT00536913
Acronym / sponsor ID: Spacer / D5897C00004
Conditions: Asthma
Keywords: Symbicort pMDI, spacer, children
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 28 Sep 2007 (estimated)
Results: Posted 27 Feb 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 the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
With Spacer	Experimental	Drug: Budesonide/formoterol pMDI 40/2.25ug + spacerBudesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer	Experimental	Drug: Budesonide/formoterol pMDI 40/2.25 ugBudesonide/formoterol pMDI 40/2.25 ug

Who may qualify

Ages: 6 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

children 6-11 years, diagnosed asthma treated
6 months, PEF
50% of predicted normal value pre-bronchodilator

Key exclusion criteria (3 listed)

current systemic glucocorticosteroids usage
current respiratory infection
any significant disease or disorder as judged by investigator

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 pMDI 40/2.25ug + spacer	Drug	With Spacer
Budesonide/formoterol pMDI 40/2.25 ug	Drug	Without Spacer

Primary outcome

Urinary Free Cortisol (UFC)
Time frame: At baseline and 4 weeks
Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment

8 secondary outcomes

Forced Expiratory Volume in 1 Second (FEV1)
Time frame: At baseline, at 2 weeks and 4 weeks
Morning Peak Expiratory Flow (mPEF)
Time frame: Daily during run-in and daily during treatment period of 6 weeks
Evening Peak Expiratory Flow (ePEF)
Time frame: Daily during run-in and daily during treatment period of 6 weeks
Asthma Symptoms at Night
Time frame: Daily during run-in and daily during treatment period of 6 weeks
Asthma Symptoms at Day
Time frame: Daily during run-in and daily during treatment period of 6 weeks
Percentage of Nights With Awakenings Due to Asthma
Time frame: Daily during run-in and daily during treatment period of 6 weeks
Use of Rescue Medication at Night
Time frame: Daily during run-in and daily during treatment period of 6 weeks
Use of Rescue Medication at Day
Time frame: Daily during run-in and daily during treatment period of 6 weeks

Results and safety

Results posted to the registry on 27 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
With Spacer	55	55
Without Spacer	52	52

Primary outcome: Urinary Free Cortisol (UFC)

Time frame: At baseline and 4 weeks. Geometric mean (Full Range). Unit: Ratio

Measure	With Spacer n = 54	Without Spacer n = 51
Value	0.86 (0.20 to 2.4)	1.03 (0.12 to 5.4)

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
With Spacer	0 of 55 (0%)	0 of 55 (0%)	Not reported
Without Spacer	0 of 52 (0%)	0 of 52 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Tomas Anderson, MD PhD study director

AstraZeneca

Piotr Kuna, MD PhD principal investigator

Uniwersytecki Spital

11 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Budesonide/formoterol pMDI 40/2.25ug + spacer and Budesonide/formoterol pMDI 40/2.25 ug in people with Asthma, run by AstraZeneca at 11 sites in 3 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 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 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Poland, 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 27 Feb 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?

Urinary Free Cortisol (UFC) (time frame: At baseline and 4 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 NCT00536913.

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 6 Apr 2012.