Pulmonary Disease, Chronic ObstructivePhase 4SACOPDNCT01253473
Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Budesonide, budesonide/formoterol and Ipratropium/albuterol in people with Pulmonary Disease, Chronic Obstructive, run by National Jewish Health at 7 sites in United States.
Trial summary
The main objective of the study is to see if using anti-inflammatory to patients with airway disease chronic obstructive pulmonary disease (COPD) phenotype will be more effective than using these treatments in patients with loss of lung tissue. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Budesonide, budesonide/formoterol and Ipratropium/albuterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2012to Jan 2016
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD GOLD Stage 2 and 3 (post-bronchodilator FEV1 35-80% predicted and FEV1/FVC <0.7 at the time of enrollment in COPDGene) by spirometry.
- Less than 15% of the lung <-950 Hounsfield Units on COPDGene high-resolution inspiratoryChest CT scan (i.e. no evidence of significant emphysema)
- Greater than 10% gas trapping on COPDGene expiratory CT scan (i.e. evidence of small airway disease).
- No history of recent use (within the pat 8 weeks) of an inhaled or systemic corticosteroid.
- Body weight <100 kg (low dose CT scans in subject with increased boyd weight can not be reliably analyzed).
Who cannot join
- Exacerbation of COPD or other respiratory illness requiring antibiotics within the past 8 weeks.
- Previous adverse reaction to inhaled steroids, long-acting beta agonists, or long-acting anticholinergic medications.
- Symptomatic, untreated benign prostate hypertrophy.
- Allergy to peanuts.
- Glaucoma
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Alabama Birmingham Medical Center
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
National Jewish Health
Denver, Colorado, 80206
University of Iowa
Iowa City, Iowa, 52242
Temple University Medical Center
Philadelphia, Pennsylvania, 19140
Harbor UCLA Medical Center
Torrance, California, 90502
Reliant Medical Group
Worcester, Massachusetts, 01608
About this study
Official title: COPDGene Ancillary Proposal: Symbicort Intervention in "Airway Predominant
The main objective of the study is to see if using anti-inflammatory to patients with airway disease chronic obstructive pulmonary disease (COPD) phenotype will be more effective than using these treatments in patients with loss of lung tissue. Symbicort plus ipratropium/albuterol will be used for 12 weeks in an open-label study in subjects with airway predominant COPD.
Read the detailed description
Subjects from the COPDGene study who have airway-predominant COPD on chest CT scan will be enrolled; a total of 40 subjects is planned.
Subjects will all have background ipratropium-albuterol administered four times daily. Subjects will be randomized to receive budesonide (180 ug twice daily) or formoterol-budesonide (160/4.5 ug twice daily) for 12 weeks.
The main objective is to explore novel outcomes: blood biomarkers and chest CT scan. Outcomes include lung function, walk distance, respiratory disease-specific health status, and expiratory chest CT scan gas trapping as an exploratory outcome.
The primary outcome measure will be FEV1 pre-bronchodilator 12 hours after the last dose of study medication at the end of 12 weeks of treatment. FEV1 will be measured in the morning 6 hours after the last dose of ipratropium/albuterol and 12 hours after the last dose of budesonide and budesonide/formoterol
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Budesonide, budesonide/formoterol, Ipratropium/albuterol
- Keywords
- COPD
- 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
Also called Pulmicort Flexhaler®
Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed
budesonide/formoterolDrug
Also called Symbicort®
Inhaled budesonide/formoterol (160/4.5 mcg Symbicort®) 2 puffs twice daily plus inhaled ipratropium/albuterol (Combivent®) 1 puff four times daily
Ipratropium/albuterolDrug
Also called Combivent®
Inhaled ipratropium/albuterol combination 2 puffs four times daily
| Study group | Role | What they receive |
|---|---|---|
| ipratropium/albuterol | Active comparator | 1 puff 4 times daily Receives: Drug: Ipratropium/albuterol |
| Budesonide | Experimental | budesonide 180 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily Receives: Drug: Budesonide; Drug: Ipratropium/albuterol |
| budesonide/formoterol | Experimental | budesonide/formoterol 160/4.5 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily Receives: Drug: budesonide/formoterol; Drug: Ipratropium/albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in 1 second (FEV1) pre-bronchodilator
FEV1 will be measured in the morning 6 hours after the last dose of ipratropium/albuterol and 12 hours after the last dose budesonide and budesonide/formoterol
Measured: 12 weeks
Secondary outcomes (9)
Health Status
Administer St. George's Respiratory Questionnaire at randomization and 12 weeks.
Measured: 12 weeks
Dyspnea
Evaluated by the Modified Medical Research Council Dyspnea Scale at randomization and week 12.
Measured: 12 weeks
Six minute walk distance
Evaluate six minute walk distance at randomization and 12 weeks
Measured: 12 weeks
Forced vital capacity (FVC) pre-bronchodilator
Measured: 12 weeks
Post-bronchodilator FEV1
Measured: 12 weeks
Patient-reported exacerbations
Measured: 12 weeks
Patient reported adverse events
Measured: 12 weeks
Post-bronchodilator FVC
Measured: 12 weeks
CT scan gas trapping
Measured: Before and 12 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startApr 2012
- Primary completionSep 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- James D Crapo, MD, Principal investigator, National Jewish HealthEdwin K Silverman, MD, PhD, Principal investigator, Brigham and Women's HospitalBarry J Make, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253473
- Sponsor's protocol ID
- SYMB0012
- Acronym
- SACOPD
- Status last verified
- Jan 2021
- First submitted
- 16 Nov 2010
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPDGene Ancillary Proposal: Symbicort Intervention in "Airway Predominant
- ClinicalTrials.gov ID
- NCT01253473
- Acronym / sponsor ID
- SACOPD / SYMB0012
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Apr 2012 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 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 objective of the study is to see if using anti-inflammatory to patients with airway disease chronic obstructive pulmonary disease (COPD) phenotype will be more effective than using these treatments in patients with loss of lung tissue. Symbicort plus ipratropium/albuterol will be used for 12 weeks in an open-label study in subjects with airway predominant COPD.
Detailed description
Subjects from the COPDGene study who have airway-predominant COPD on chest CT scan will be enrolled; a total of 40 subjects is planned.
Subjects will all have background ipratropium-albuterol administered four times daily. Subjects will be randomized to receive budesonide (180 ug twice daily) or formoterol-budesonide (160/4.5 ug twice daily) for 12 weeks.
The main objective is to explore novel outcomes: blood biomarkers and chest CT scan. Outcomes include lung function, walk distance, respiratory disease-specific health status, and expiratory chest CT scan gas trapping as an exploratory outcome.
The primary outcome measure will be FEV1 pre-bronchodilator 12 hours after the last dose of study medication at the end of 12 weeks of treatment. FEV1 will be measured in the morning 6 hours after the last dose of ipratropium/albuterol and 12 hours after the last dose of budesonide and budesonide/formoterol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ipratropium/albuterol | Active comparator | Drug: Ipratropium/albuterol1 puff 4 times daily |
| Budesonide | Experimental | Drug: Budesonide, Drug: Ipratropium/albuterolbudesonide 180 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily |
| budesonide/formoterol | Experimental | Drug: budesonide/formoterol, Drug: Ipratropium/albuterolbudesonide/formoterol 160/4.5 ug 2 puffs 4 times daily + ipratropium/albuterol 1 puffs four times daily |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD GOLD Stage 2 and 3 (post-bronchodilator FEV1 35-80% predicted and FEV1/FVC <0.7 at the time of enrollment in COPDGene) by spirometry.
- Less than 15% of the lung <-950 Hounsfield Units on COPDGene high-resolution inspiratoryChest CT scan (i.e. no evidence of significant emphysema)
- Greater than 10% gas trapping on COPDGene expiratory CT scan (i.e. evidence of small airway disease).
- No history of recent use (within the pat 8 weeks) of an inhaled or systemic corticosteroid.
- Body weight <100 kg (low dose CT scans in subject with increased boyd weight can not be reliably analyzed).
Key exclusion criteria (5 listed)
- Exacerbation of COPD or other respiratory illness requiring antibiotics within the past 8 weeks.
- Previous adverse reaction to inhaled steroids, long-acting beta agonists, or long-acting anticholinergic medications.
- Symptomatic, untreated benign prostate hypertrophy.
- Allergy to peanuts.
- Glaucoma
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 |
|---|---|---|
| BudesonideAlso: Pulmicort Flexhaler®Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed | Drug | Budesonide |
| budesonide/formoterolAlso: Symbicort®Inhaled budesonide/formoterol (160/4.5 mcg Symbicort®) 2 puffs twice daily plus inhaled ipratropium/albuterol (Combivent®) 1 puff four times daily | Drug | budesonide/formoterol |
| Ipratropium/albuterolAlso: Combivent®Inhaled ipratropium/albuterol combination 2 puffs four times daily | Drug | Budesonide, budesonide/formoterol, ipratropium/albuterol |
Primary outcome
Forced expiratory volume in 1 second (FEV1) pre-bronchodilator
Time frame: 12 weeks
FEV1 will be measured in the morning 6 hours after the last dose of ipratropium/albuterol and 12 hours after the last dose budesonide and budesonide/formoterol
9 secondary outcomes
Health Status
Time frame: 12 weeks
Dyspnea
Time frame: 12 weeks
Six minute walk distance
Time frame: 12 weeks
Forced vital capacity (FVC) pre-bronchodilator
Time frame: 12 weeks
Post-bronchodilator FEV1
Time frame: 12 weeks
Patient-reported exacerbations
Time frame: 12 weeks
Patient reported adverse events
Time frame: 12 weeks
Post-bronchodilator FVC
Time frame: 12 weeks
CT scan gas trapping
Time frame: Before and 12 weeks after randomization
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 19 Jan 2021.
- Individual participant dataSharing planned: No
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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.
James D Crapo, MD principal investigator
National Jewish Health
Edwin K Silverman, MD, PhD principal investigator
Brigham and Women's Hospital
Barry J Make, MD principal investigator
National Jewish Health
7 sites 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, budesonide/formoterol and Ipratropium/albuterol in people with Pulmonary Disease, Chronic Obstructive, run by National Jewish Health at 7 sites 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 5 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 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. 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?
Forced expiratory volume in 1 second (FEV1) pre-bronchodilator (time frame: 12 weeks). 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 19 Jan 2021.