Stable AsthmaPhase 2NCT00658255

Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler

A Phase 2 study testing budesonide/formoterol and formoterol in people with Stable Asthma, run by AstraZeneca.

Completed

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

Trial summary

The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stable Asthma
What is being tested?: budesonide/formoterol and formoterol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 175 participants
Where: No sites listed yet
Study dates: Oct 2002to May 2003
Phase: Phase 2
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

At least 18 years of age
Diagnosis of asthma and baseline lung function tests as determined by the protocol
Required and received treatment with inhaled corticosteroids within timeframe and doses specified in the protocol

Who cannot join

Severe asthma
Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

About this study

Official title: A Randomized, Multicenter, Open-label, Active-controlled, Single-dose, 5-period, Incomplete Block, Cross-over Study to Evaluate the Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort pMDI or Oxis Turbuhaler to Adults With Stable Asthma

The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.

Conditions: Stable Asthma
Being tested: budesonide/formoterol, formoterol
Keywords: stable asthma, adults, formoterol, Symbicort, Oxis Turbuhaler, bronchodilation

What participants receive

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

budesonide/formoterolDrug
Also called Symbicort
formoterolDrug
Also called Oxis Turbuhaler

Study groups in NCT00658255
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: budesonide/formoterol
2	Active comparator	Not described Receives: Drug: formoterol

What is being measured

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

Average FEV1 during 12 hours
Measured: Once a week for 5 weeks during treatment period

Secondary outcomes (2)

Urine levels of formoterol in 2 different formulations
Measured: Once a week (12 hour urine collection) for 5 weeks during treatment period
Safety profiles of formoterol in 2 different formulations
Measured: Once a week for 5 weeks during treatment period

Timeline

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

Oct 2002May 2003

First posted14 Apr 2008 (estimated)
Study startOct 2002
Study completionMay 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stable 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 175 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00658255
Sponsor's protocol ID: SD-039-0729
Other IDs: D5896C00729
Status last verified: Jan 2011
First submitted: 1 Apr 2008
Last updated: 24 Jan 2011
Results posted: No
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?

Official record

Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
Asthma
Recruiting
Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma
Mild Asthma
RecruitingPhase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Asthma
RecruitingObservational study
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
Asthma

All Stable Asthma trials

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 Randomized, Multicenter, Open-label, Active-controlled, Single-dose, 5-period, Incomplete Block, Cross-over Study to Evaluate the Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort pMDI or Oxis Turbuhaler to Adults With Stable Asthma
ClinicalTrials.gov ID: NCT00658255
Acronym / sponsor ID: SD-039-0729
Conditions: Stable Asthma
Keywords: stable asthma, adults, formoterol, Symbicort, Oxis Turbuhaler, bronchodilation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 175 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2002
Study completion: May 2003 (actual)
First posted: 14 Apr 2008 (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 compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.

Study design

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

Arm	Type	Receives
1	Experimental	Drug: budesonide/formoterol
2	Active comparator	Drug: formoterol

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

At least 18 years of age
Diagnosis of asthma and baseline lung function tests as determined by the protocol
Required and received treatment with inhaled corticosteroids within timeframe and doses specified in the protocol

Key exclusion criteria (2 listed)

Severe asthma
Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

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/formoterolAlso: Symbicort	Drug	1
formoterolAlso: Oxis Turbuhaler	Drug	2

Primary outcome

Average FEV1 during 12 hours
Time frame: Once a week for 5 weeks during treatment period

2 secondary outcomes

Urine levels of formoterol in 2 different formulations
Time frame: Once a week (12 hour urine collection) for 5 weeks during treatment period
Safety profiles of formoterol in 2 different formulations
Time frame: Once a week for 5 weeks during treatment period

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.

Related trials for Stable Asthma

Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
Asthma
Recruiting
Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma
Mild Asthma
RecruitingPhase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Asthma
RecruitingObservational study
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent 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.

Michael E Ruff, MD study director

Pharmaceutical Research & Consulting Inc

Catherine Bonuccelli study chair

AstraZeneca

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing budesonide/formoterol and formoterol in people with Stable Asthma, run by AstraZeneca.

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 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Average FEV1 during 12 hours (time frame: Once a week for 5 weeks during treatment period). 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 NCT00658255.

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.