Chronic Obstructive Lung DiseasePhase 4NCT01712854
Effects of Symbicort on the Ventilatory Kinematics
A Phase 4 study testing Budesonide and Symbicort in people with Chronic Obstructive Lung Disease, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to investigate how budesonide/formoterol fumarate dihydrate (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using Optoelectronic Plethysmography (OEP). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Lung Disease
- What is being tested?
- Budesonide and Symbicort
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2012
- Phase
- Phase 4
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe COPD by Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
- Approval by pulmonologist
- Informed consent
- Age 40 to 75
- Males and females
- All races
- Ex smoker or non smoker
- Prior therapy allowed
Who cannot join
- No active cardiac disease
- Alpha1 Antitrypsin Deficiency
- Active smoking
- Reactive Airways Disease
- Pulmonary Hypertension
- Comorbid conditions preventing exercise (arthritic, neurologic, vascular, or other conditions)
Show all 9Show fewer
- BMI>30
- Current enrollment in any other concurrent study at Columbia University Medical Center or sponsored by AstraZeneca at any other sites
- Participation in any pharmacologic studies in the last 6 months prior to enrollment in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Investigating the Effects of Symbicort on the Ventilatory Kinematics in Patients With Obstructive Disease With Optoelectronic Plethysmography
The purpose of this study is to investigate how budesonide/formoterol fumarate dihydrate (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using Optoelectronic Plethysmography (OEP). This study is unique as it will be the first randomized, doubleblind, crossover study with a placebo inhaler and budesonide/formoterol fumarate dihydrate as the intervention which will evaluate the effects on ventilatory mechanics through the use of OEP. The investigators plan to demonstrate that budesonide/formoterol fumarate dihydrate impacts dynamic hyperinflation which can be detected with OEP, and that budesonide/formoterol fumarate dihydrate may have an effect in the short term on exercise capacity during a constant load exercise test. The changes in ventilatory mechanics measured after budesonide/formoterol fumarate dihydrate by OEP will provide a unique evaluation of budesonide/formoterol fumarate dihydrate in a controlled setting also demonstrating the utility of OEP in evaluating of the effects of a medical treatment on hyperinflation in individuals with chronic obstructive lung disease (COPD).
- Primary Objective/Hypothesis: Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. The investigators hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.
- Primary Endpoint: Our primary endpoint is the change in dynamic hyperinflation, specifically end expiratory volumes, dynamic lung volumes and diaphragmatic paradoxical breathing as measured by OEP.
- Secondary Objective: Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.
- Secondary endpoint: Exercise time, change in Borg scale at rest vs. Borg scale at steady state vs. Borg at end exercise.
Read the detailed description
This study will be a prospective, randomized, double blind, crossover interventional design. The crossover allows for equality in number of subjects assigned to each treatment and for subjects to be their own controls. Baseline spirometry will be taken prior to exercise test. Subjects will be prepared for OEP. All exercise will take place on an electromagnetically braked cycle ergometer. Throughout the protocol heart rate, blood pressure, O2 saturation, ventilation, and metabolic data will be recorded. A modified exercise induced asthma protocol will be used. Unlike prior studies, ventilatory kinematics (with isolated diaphragmatic function) will be monitored throughout exercise using biomechanical motion analysis (OEP). This OEP analysis involves compartmentalization of the chest into three sections; 1) pulmonary rib cage, 2) diaphragmatic rib cage, and 3) abdomen to determine the contribution of each component to total lung volume. By measuring the percent contribution of compartment, we are able to better understand its impact on respiration. OEP will be able to quantify and assess the distortion effects of dynamic hyperinflation and obstruction.
Twenty moderate to severe COPD patients will be recruited. Subjects will refrain from their usual inhaled medications for 24 hours prior to the testing session. All subjects will be asked to verify that this is acceptable with their pulmonologist prior to participation. Subjects will also be asked to have their short acting bronchodilators and other regular medications available to be taken if symptoms should occur. During the initial screening, subjects will be familiarized with all procedures. Then baseline pulmonary function testing, and baseline resting OEP measurements will be performed. The subjects will then be randomized to receive either budesonide/formoterol fumarate dihydrate (Symbicort) or a placebo of budesonide only (Entocort EC). At that time, they will receive treatment with either placebo or budesonide/formoterol fumarate dihydrate and after 45 minutes, they will repeat spirometry and OEP and submaximal exercise testing with OEP. After one week, subjects will be tested again and switched to the opposite treatment (i.e. if on budesonide/formoterol fumarate dihydrate initially then switch to placebo and vice versa). The one week washout period between tests will include a resumption of the usual medications. The subjects will refrain from their inhaled medications for 24 hours before the second testing session, but use all of their other usual medications.
- Conditions
- Chronic Obstructive Lung Disease
- Being tested
- Budesonide, Symbicort
- Keywords
- COPD, Chronic Obstructive Lung Disease, Long acting beta agonist
- 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.
BudesonideDrug
budesonide 80 mcg
SymbicortDrug
A combination of budesonide and long acting beta agonist: Budesonide 80 mcg and formoterol fumarate dihydrate inhaler 4.5 mcg
| Study group | Role | What they receive |
|---|---|---|
| Symbicort | Experimental | A combination of budesonide + long acting beta agonist (Symbicort): Budesonide 80 mcg and formoterol fumarate dihydrate inhaler 4.5 mcg Receives: Drug: Symbicort |
| Budesonide only | Placebo comparator | Budesonide 80 mcg (Entocort EC) only Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Dynamic Hyperinflation Measured by End Expiratory Volumes Recorded by Optoelectronic Plethysmography (OEP).
Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.
Measured: 2 hours
Secondary outcomes (1)
Exercise Time in Steady State Exercise
Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Closed by study sponsor; PI left the institution; responsible party changed to Columbia
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 Chronic Obstructive Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Matthew Bartels, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712854
- Sponsor's protocol ID
- AAAI1932
- Status last verified
- Jul 2016
- First submitted
- 21 Oct 2012
- Last updated
- 2 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Symbicort on the Ventilatory Kinematics in Patients With Obstructive Disease With Optoelectronic Plethysmography
- ClinicalTrials.gov ID
- NCT01712854
- Acronym / sponsor ID
- AAAI1932
- Conditions
- Chronic Obstructive Lung Disease
- Keywords
- COPD, Chronic Obstructive Lung Disease, Long acting beta agonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed by study sponsor; PI left the institution; responsible party changed to Columbia
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 24 Oct 2012 (estimated)
- Results
- Posted 22 Apr 2016
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 investigate how budesonide/formoterol fumarate dihydrate (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using Optoelectronic Plethysmography (OEP). This study is unique as it will be the first randomized, doubleblind, crossover study with a placebo inhaler and budesonide/formoterol fumarate dihydrate as the intervention which will evaluate the effects on ventilatory mechanics through the use of OEP. The investigators plan to demonstrate that budesonide/formoterol fumarate dihydrate impacts dynamic hyperinflation which can be detected with OEP, and that budesonide/formoterol fumarate dihydrate may have an effect in the short term on exercise capacity during a constant load exercise test. The changes in ventilatory mechanics measured after budesonide/formoterol fumarate dihydrate by OEP will provide a unique evaluation of budesonide/formoterol fumarate dihydrate in a controlled setting also demonstrating the utility of OEP in evaluating of the effects of a medical treatment on hyperinflation in individuals with chronic obstructive lung disease (COPD).
- Primary Objective/Hypothesis: Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. The investigators hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.
- Primary Endpoint: Our primary endpoint is the change in dynamic hyperinflation, specifically end expiratory volumes, dynamic lung volumes and diaphragmatic paradoxical breathing as measured by OEP.
- Secondary Objective: Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.
- Secondary endpoint: Exercise time, change in Borg scale at rest vs. Borg scale at steady state vs. Borg at end exercise.
Detailed description
This study will be a prospective, randomized, double blind, crossover interventional design. The crossover allows for equality in number of subjects assigned to each treatment and for subjects to be their own controls. Baseline spirometry will be taken prior to exercise test. Subjects will be prepared for OEP. All exercise will take place on an electromagnetically braked cycle ergometer. Throughout the protocol heart rate, blood pressure, O2 saturation, ventilation, and metabolic data will be recorded. A modified exercise induced asthma protocol will be used. Unlike prior studies, ventilatory kinematics (with isolated diaphragmatic function) will be monitored throughout exercise using biomechanical motion analysis (OEP). This OEP analysis involves compartmentalization of the chest into three sections; 1) pulmonary rib cage, 2) diaphragmatic rib cage, and 3) abdomen to determine the contribution of each component to total lung volume. By measuring the percent contribution of compartment, we are able to better understand its impact on respiration. OEP will be able to quantify and assess the distortion effects of dynamic hyperinflation and obstruction.
Twenty moderate to severe COPD patients will be recruited. Subjects will refrain from their usual inhaled medications for 24 hours prior to the testing session. All subjects will be asked to verify that this is acceptable with their pulmonologist prior to participation. Subjects will also be asked to have their short acting bronchodilators and other regular medications available to be taken if symptoms should occur. During the initial screening, subjects will be familiarized with all procedures. Then baseline pulmonary function testing, and baseline resting OEP measurements will be performed. The subjects will then be randomized to receive either budesonide/formoterol fumarate dihydrate (Symbicort) or a placebo of budesonide only (Entocort EC). At that time, they will receive treatment with either placebo or budesonide/formoterol fumarate dihydrate and after 45 minutes, they will repeat spirometry and OEP and submaximal exercise testing with OEP. After one week, subjects will be tested again and switched to the opposite treatment (i.e. if on budesonide/formoterol fumarate dihydrate initially then switch to placebo and vice versa). The one week washout period between tests will include a resumption of the usual medications. The subjects will refrain from their inhaled medications for 24 hours before the second testing session, but use all of their other usual medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbicort | Experimental | Drug: SymbicortA combination of budesonide + long acting beta agonist (Symbicort): Budesonide 80 mcg and formoterol fumarate dihydrate inhaler 4.5 mcg |
| Budesonide only | Placebo comparator | Drug: BudesonideBudesonide 80 mcg (Entocort EC) only |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Moderate to severe COPD by Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
- Approval by pulmonologist
- Informed consent
- Age 40 to 75
- Males and females
Key exclusion criteria (9 listed)
- No active cardiac disease
- Alpha1 Antitrypsin Deficiency
- Active smoking
- Reactive Airways Disease
- Pulmonary Hypertension
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 |
|---|---|---|
| Budesonidebudesonide 80 mcg | Drug | Budesonide only |
| SymbicortA combination of budesonide and long acting beta agonist: Budesonide 80 mcg and formoterol fumarate dihydrate inhaler 4.5 mcg | Drug | Symbicort |
Primary outcome
The Change in Dynamic Hyperinflation Measured by End Expiratory Volumes Recorded by Optoelectronic Plethysmography (OEP).
Time frame: 2 hours
Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.
1 secondary outcome
Exercise Time in Steady State Exercise
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Matthew Bartels, MD, MPH principal investigator
Columbia University
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 Budesonide and Symbicort in people with Chronic Obstructive Lung Disease, run by Columbia University at 1 site in United States.
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 9 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: stopped early, as of the sponsor's last update on 2 Sep 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2016). 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?
The Change in Dynamic Hyperinflation Measured by End Expiratory Volumes Recorded by Optoelectronic Plethysmography (OEP). (time frame: 2 hours). 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 2 Sep 2016.