Chronic Obstructive Pulmonary DiseasePhase 4NCT01329276
Assess Particle Deposition and Acute Effects of Symbicort® Forte Turbohaler®) in COPD Patients.
A Phase 4 study testing Symbicort® forte Turbohaler® in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Computational Fluid Dynamics (CFD) is a new functional imaging method. Since CFD is very sensitive to detect small changes, it might be worthwhile to study the acute effect of formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper airway dimensions in severe COPD patients (GOLD III). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Symbicort® forte Turbohaler®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2010to Jan 2011
- Phase
- Phase 4
- 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
- Patients with documented COPD based on the following criteria:
- Smoking history of at least 10 pack-years and decreased Tiffeneau index (FEV1/(F)VC < 0.70).
- Patients should present severe COPD with an FEV1 between 50 and 30% of predicted (GOLD 3).
- Male or female patients aged ≥ 40 years.
- Patients should be treated according to GOLD guidelines before study start.
- Patients with, in the opinion of the investigator, a co-operative attitude and ability to be trained to correctly use the TurbohalerR.
- Maintained on stable respiratory medications for 6 weeks prior to visit 1.
- Written informed consent obtained.
Who cannot join
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
- Inability to carry out pulmonary function testing.
- A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
- Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study
- A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
- Cancer or any other chronic disease with poor prognosis and/or affecting patient status.
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- A history of thoracotomy with pulmonary resection.
- Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients.
- History of alcohol or drug abuse.
- Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
- Patients who received any investigational new drug within the last 4 weeks prior to the screening visit.
- Patients treated with any non-permitted concomitant medication (see 7.2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Two Way Cross-over Study to Assess the Particle Deposition and Acute Effects of Formoterol and Budesonide Combination Therapy (Symbicort® Forte Turbohaler®) on the Upper Airway Dimensions in COPD Patients.
Computational Fluid Dynamics (CFD) is a new functional imaging method. Since CFD is very sensitive to detect small changes, it might be worthwhile to study the acute effect of formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper airway dimensions in severe COPD patients (GOLD III). The increased sensitivity of this technique makes it possible to detect changes in airway caliber in early stages. The regional distribution of resistance and the change in this parameter will provide more insight into the mode of action of the product.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Symbicort® forte Turbohaler®
- Keywords
- COPD, Symbicort, Turbohaler, Computational Fluid Dynamics, Functional Imaging, Budesonide, Formoterol
- 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.
Symbicort® forte Turbohaler®Drug
320 µg budesonide / 9 µg formoterol fumarate dihydrate
| Study group | Role | What they receive |
|---|---|---|
| Symbicort® forte Turbohaler® | Other | Not described Receives: Drug: Symbicort® forte Turbohaler® |
| Placebo (lactose) | Placebo comparator | Not described Receives: Drug: Symbicort® forte Turbohaler® |
What is being measured
The primary outcome is the main question the study is designed to answer.
total airway resistance
To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume.
total airway volume
To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume.
Secondary outcomes (1)
effect of formoterol and budesonide combination therapy on lung function
The secondary objective of this study is to assess the effect of formoterol and budesonide combination therapy on lung function (spirometry, body plethysmography and resistance).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startJun 2010
- Primary completionNov 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Wilfried A De Backer, MD PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329276
- Sponsor's protocol ID
- PML_DOC_0905_/_ISSSYMB0020
- Other IDs
- 2009-016502-16, 2009
- Status last verified
- Mar 2011
- First submitted
- 30 Mar 2011
- Last updated
- 5 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Two Way Cross-over Study to Assess the Particle Deposition and Acute Effects of Formoterol and Budesonide Combination Therapy (Symbicort® Forte Turbohaler®) on the Upper Airway Dimensions in COPD Patients.
- ClinicalTrials.gov ID
- NCT01329276
- Acronym / sponsor ID
- PML_DOC_0905_/_ISSSYMB0020
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Symbicort, Turbohaler, Computational Fluid Dynamics, Functional Imaging, Budesonide, Formoterol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jun 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 5 Apr 2011 (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.
Computational Fluid Dynamics (CFD) is a new functional imaging method. Since CFD is very sensitive to detect small changes, it might be worthwhile to study the acute effect of formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper airway dimensions in severe COPD patients (GOLD III). The increased sensitivity of this technique makes it possible to detect changes in airway caliber in early stages. The regional distribution of resistance and the change in this parameter will provide more insight into the mode of action of the product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbicort® forte Turbohaler® | Other | Drug: Symbicort® forte Turbohaler® |
| Placebo (lactose) | Placebo comparator | Drug: Symbicort® forte Turbohaler® |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with documented COPD based on the following criteria:
- Smoking history of at least 10 pack-years and decreased Tiffeneau index (FEV1/(F)VC < 0.70).
- Patients should present severe COPD with an FEV1 between 50 and 30% of predicted (GOLD 3).
- Male or female patients aged ≥ 40 years.
- Patients should be treated according to GOLD guidelines before study start.
Key exclusion criteria (12 listed)
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
- Inability to carry out pulmonary function testing.
- A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
- Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study
- A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
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 |
|---|---|---|
| Symbicort® forte Turbohaler®320 µg budesonide / 9 µg formoterol fumarate dihydrate | Drug | Placebo (lactose), Symbicort® forte Turbohaler® |
Primary outcome
total airway resistance
To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume.
total airway volume
To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume.
1 secondary outcome
effect of formoterol and budesonide combination therapy on lung function
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 5 Apr 2011.
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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.
Wilfried A De Backer, MD PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Symbicort® forte Turbohaler® in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Antwerp at 1 site in Belgium.
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 8 inclusion and 12 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 5 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
total airway resistance. 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?
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 5 Apr 2011.