COPD Method EvaluationEarly Phase 1NCT01257048
Evaluation of an Oxygen Enhanced Magnetic Resonance Imaging Method on Patients With Chronic Obstructive Pulmonary Disease During 8 Weeks Treatment With Either Symbicort Turbuhaler or Oxis Turbuhaler
A Early Phase 1 study testing Formoterol Turbuhaler and Budesonide/Formoterol Turbuhaler in people with COPD Method Evaluation and Chronic Obstructive Pulmonary Disease Method Evaluation, run by AstraZeneca at 2 sites in 2 countries.
Trial summary
The main purpose of this study is to evaluate the sensitivity of a new oxygen enhanced magnetic resonance imaging (OE-MRI) method in detecting changes in the lungs of patients with moderate to severe chronic obstructive pulmonary disease (COPD) following treatment with either Oxis Turbuhaler or Symbicort Turbuhaler. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Method Evaluation, Chronic Obstructive Pulmonary Disease Method Evaluation
- What is being tested?
- Formoterol Turbuhaler and Budesonide/Formoterol Turbuhaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2011to Jun 2012
- Phase
- Early Phase 1
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 40 years
- Male and female
- Clinical diagnosis of moderate to severe COPD according GOLD guidelines
- Current or ex smoker with a smoking history equivalent to at least 20 cigarettes smoked per day for 10 years
- A Modified Medical Research Council (MMRC) dyspnoea scale score of ≥2.
- FEV1/FVC < 0.7 (post-bronchodilator)
Show all 9Show fewer
- FEV1 > 40 % PN and < 70 % PN (post-bronchodilator)
- Clinical Study Protocol Local Amendment affects UK:
- FEV1 > 30 % PN and < 80 % PN (post-bronchodilator)
Who cannot join
- Current diagnosis of asthma according to GINA guidelines
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures as judged by the investigator
- Significant upper or lower respiratory tract infection not fully recovered in the 4 weeks prior to visit 1
- Participation in or scheduled for an intensive COPD rehabilitation program
- Claustrophobia, pacemaker, clips within the brain, previous brain or heart surgery, history of metal in the eye or other MRI contraindication such as obesity or inability to stay in the supine position for 60 minutes
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Open, Randomised, Parallel Group Multi-centre, Methodology Study, Evaluating the Sensitivity of Oxygen-Enhanced Magnetic Resonance Imaging (OE-MRI) in Detecting and Comparing Response to 8 Weeks Treatment With Budesonide/Formoterol Turbuhaler® (320/9 µg Bid) and Formoterol Turbuhaler® (9 µg Bid) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The main purpose of this study is to evaluate the sensitivity of a new oxygen enhanced magnetic resonance imaging (OE-MRI) method in detecting changes in the lungs of patients with moderate to severe chronic obstructive pulmonary disease (COPD) following treatment with either Oxis Turbuhaler or Symbicort Turbuhaler.
- Being tested
- Formoterol Turbuhaler, Budesonide/Formoterol Turbuhaler
- Keywords
- Oxygen enhanced magnetic resonance imaging, chronic obstructive pulmonary disease, method evaluation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formoterol TurbuhalerDrug
9 microgram on visit 5 single dose
Budesonide/Formoterol TurbuhalerDrug
320/9 microgram twice daily during 8 weeks
Formoterol TurbuhalerDrug
9 microgram twice daily during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Single Dose evaluation placebo (V5) Receives: Drug: Formoterol Turbuhaler |
| 2 | Active comparator | Single Dose evaluation formoterol (V5) Receives: Drug: Budesonide/Formoterol Turbuhaler; Drug: Formoterol Turbuhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen enhanced MRI V4
Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters
Measured: Visit 4
Oxygen enhanced MRI V5
Oxygen enhanced MRI parameters
Measured: Visit 5
Oxygen enhanced MRI V7
Oxygen enhanced MRI parameters
Measured: Visit 7
Secondary outcomes (6)
Transferability of OE-MRI technique
Transferability of OE-MRI technique to a second centre
Measured: 10 months
OE-MRI variables
Relationship with OE-MRI variables and change in lung function
Measured: patients will fill in a patient diary at home between visit 2 and 7
Impulse oscillometry parameters V2
Impulse oscillometry parameters
Measured: Visit 2
Impulse oscillometry parameters V4
Impulse oscillometry parameters
Measured: Visit 4
Impulse oscillometry parameters V5
Impulse oscillometry parameters
Measured: Visit 5
Impulse oscillometry parameters V7
Impulse oscillometry parameters
Measured: Visit 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Method EvaluationStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257048
- Sponsor's protocol ID
- D6256M00046
- Other IDs
- 2010-023751
- Status last verified
- Aug 2012
- First submitted
- 3 Dec 2010
- Last updated
- 3 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomised, Parallel Group Multi-centre, Methodology Study, Evaluating the Sensitivity of Oxygen-Enhanced Magnetic Resonance Imaging (OE-MRI) in Detecting and Comparing Response to 8 Weeks Treatment With Budesonide/Formoterol Turbuhaler® (320/9 µg Bid) and Formoterol Turbuhaler® (9 µg Bid) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01257048
- Acronym / sponsor ID
- D6256M00046
- Keywords
- Oxygen enhanced magnetic resonance imaging, chronic obstructive pulmonary disease, method evaluation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Dec 2010 (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 main purpose of this study is to evaluate the sensitivity of a new oxygen enhanced magnetic resonance imaging (OE-MRI) method in detecting changes in the lungs of patients with moderate to severe chronic obstructive pulmonary disease (COPD) following treatment with either Oxis Turbuhaler or Symbicort Turbuhaler.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Formoterol TurbuhalerSingle Dose evaluation placebo (V5) |
| 2 | Active comparator | Drug: Budesonide/Formoterol Turbuhaler, Drug: Formoterol TurbuhalerSingle Dose evaluation formoterol (V5) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age greater than or equal to 40 years
- Male and female
- Clinical diagnosis of moderate to severe COPD according GOLD guidelines
- Current or ex smoker with a smoking history equivalent to at least 20 cigarettes smoked per day for 10 years
- A Modified Medical Research Council (MMRC) dyspnoea scale score of ≥2.
Key exclusion criteria (5 listed)
- Current diagnosis of asthma according to GINA guidelines
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures as judged by the investigator
- Significant upper or lower respiratory tract infection not fully recovered in the 4 weeks prior to visit 1
- Participation in or scheduled for an intensive COPD rehabilitation program
- Claustrophobia, pacemaker, clips within the brain, previous brain or heart surgery, history of metal in the eye or other MRI contraindication such as obesity or inability to stay in the supine position for 60 minutes
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 |
|---|---|---|
| Formoterol Turbuhaler9 microgram on visit 5 single dose | Drug | 1 |
| Budesonide/Formoterol Turbuhaler320/9 microgram twice daily during 8 weeks | Drug | 2 |
| Formoterol Turbuhaler9 microgram twice daily during 8 weeks | Drug | 2 |
Primary outcome
Oxygen enhanced MRI V4
Time frame: Visit 4
Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters
Oxygen enhanced MRI V5
Time frame: Visit 5
Oxygen enhanced MRI parameters
Oxygen enhanced MRI V7
Time frame: Visit 7
Oxygen enhanced MRI parameters
6 secondary outcomes
Transferability of OE-MRI technique
Time frame: 10 months
OE-MRI variables
Time frame: patients will fill in a patient diary at home between visit 2 and 7
Impulse oscillometry parameters V2
Time frame: Visit 2
Impulse oscillometry parameters V4
Time frame: Visit 4
Impulse oscillometry parameters V5
Time frame: Visit 5
Impulse oscillometry parameters V7
Time frame: Visit 7
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 3 Sep 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Formoterol Turbuhaler and Budesonide/Formoterol Turbuhaler in people with COPD Method Evaluation and Chronic Obstructive Pulmonary Disease Method Evaluation, run by AstraZeneca at 2 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 9 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 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden, United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Oxygen enhanced MRI V4 (time frame: Visit 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2012.