Chronic Obstructive Pulmonary Disease (COPD)NCT00233051
Evaluating Genes in Sputum to Measure Drug Response in COPD
A study testing Salmeterol or Salmeterol/Fluticasone in people with Chronic Obstructive Pulmonary Disease (COPD) and Emphysema, run by National Jewish Health at 1 site in United States.
Trial summary
The purpose of this research study is to determine whether analysis of genes in sputum is a useful noninvasive technique for measuring response to drugs in patients with COPD. We propose to use polymerase chain reaction to evaluate gene expression in induced sputum from adult current smokers with moderate COPD, adult… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Emphysema, Chronic Bronchitis
- What is being tested?
- Salmeterol or Salmeterol/Fluticasone
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jun 2006
- Phase
- Interventional
- 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
- Twenty adult subjects ≥ 40 years of age and ≥ 10 pack/year cigarette history will be evaluated.
- Subjects will be recruited such that one-half are current smokers and one-half are former smokers.
- All subjects will have COPD (FEV1/FVC < 70% and FEV1 => 40% predicted).
- Airway hyperresponsiveness and diffusion capacity for carbon monoxide will also be performed to more precisely characterize the physiologic phenotype in these subjects.
Who cannot join
- Subjects will be excluded if they have used inhaled or systemic corticosteroid or antibiotic use within 6 weeks or if they are currently treated with theophylline.
- A 6 weeks run off after an upper respiratory infection will be required for qualifying subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Jewish Medical and Research Center
Denver, Colorado, 80206
About this study
Official title: Expression of Inflammatory Mediators in Induced Sputum: A Potential Biomarker of Drug Response in COPD
The purpose of this research study is to determine whether analysis of genes in sputum is a useful noninvasive technique for measuring response to drugs in patients with COPD.
We propose to use polymerase chain reaction to evaluate gene expression in induced sputum from adult current smokers with moderate COPD, adult former smokers with moderate COPD. This study is designed to determine whether changes in expression of previously-identified inflammatory markers in induced sputum can be detected in response to drug therapy in COPD and to evaluate potential differences in the expression of these markers in adult smokers with and without COPD. Pre- and post-treatment serum will be obtained to facilitate proteomic analysis of therapeutic response as well. Changes in sputum gene expression in response to treatment will be the primary outcome variable in this study. Secondary outcomes will include changes in lung function, as well as changes in induced sputum inflammation. These endpoints will be evaluated before and directly after 6 weeks of randomly-assigned treatment with either salmeterol xinafoate or fluticasone propionate/50mcg salmeterol xinafoate combination DPI bid. Endpoints will be re-evaluated following a 4 week wash-out period.
- Being tested
- Salmeterol or Salmeterol/Fluticasone
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Emphysema, Chronic Bronchitis, Inhaled Steroid, Salmeterol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmeterol or Salmeterol/FluticasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Induced Sputum Gene Expression
Secondary outcomes (1)
Lung Function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startApr 2003
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- E Rand Sutherland, MD, MPH, Principal investigator, National Jewish Medical and Research Center Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233051
- Sponsor's protocol ID
- HS-1728
- Status last verified
- Mar 2017
- First submitted
- 3 Oct 2005
- Last updated
- 29 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Inflammatory Mediators in Induced Sputum: A Potential Biomarker of Drug Response in COPD
- ClinicalTrials.gov ID
- NCT00233051
- Acronym / sponsor ID
- HS-1728
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Emphysema, Chronic Bronchitis, Inhaled Steroid, Salmeterol
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 5 Oct 2005 (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 research study is to determine whether analysis of genes in sputum is a useful noninvasive technique for measuring response to drugs in patients with COPD.
We propose to use polymerase chain reaction to evaluate gene expression in induced sputum from adult current smokers with moderate COPD, adult former smokers with moderate COPD. This study is designed to determine whether changes in expression of previously-identified inflammatory markers in induced sputum can be detected in response to drug therapy in COPD and to evaluate potential differences in the expression of these markers in adult smokers with and without COPD. Pre- and post-treatment serum will be obtained to facilitate proteomic analysis of therapeutic response as well. Changes in sputum gene expression in response to treatment will be the primary outcome variable in this study. Secondary outcomes will include changes in lung function, as well as changes in induced sputum inflammation. These endpoints will be evaluated before and directly after 6 weeks of randomly-assigned treatment with either salmeterol xinafoate or fluticasone propionate/50mcg salmeterol xinafoate combination DPI bid. Endpoints will be re-evaluated following a 4 week wash-out period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Twenty adult subjects ≥ 40 years of age and ≥ 10 pack/year cigarette history will be evaluated.
- Subjects will be recruited such that one-half are current smokers and one-half are former smokers.
- All subjects will have COPD (FEV1/FVC < 70% and FEV1 => 40% predicted).
- Airway hyperresponsiveness and diffusion capacity for carbon monoxide will also be performed to more precisely characterize the physiologic phenotype in these subjects.
Key exclusion criteria (2 listed)
- Subjects will be excluded if they have used inhaled or systemic corticosteroid or antibiotic use within 6 weeks or if they are currently treated with theophylline.
- A 6 weeks run off after an upper respiratory infection will be required for qualifying subjects.
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 |
|---|---|---|
| Salmeterol or Salmeterol/Fluticasone | Drug | – |
Primary outcome
Induced Sputum Gene Expression
1 secondary outcome
Lung Function
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
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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.
E Rand Sutherland, MD, MPH principal investigator
National Jewish Medical and Research Center Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salmeterol or Salmeterol/Fluticasone in people with Chronic Obstructive Pulmonary Disease (COPD) and Emphysema, run by National Jewish Health 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 4 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: stopped early, as of the sponsor's last update on 29 Mar 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Induced Sputum Gene Expression. 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 29 Mar 2017.