COPDNCT00568347
Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange
An observational study of COPD, run by Arthur F Gelb MD at 1 site in United States.
Trial summary
To evaluate the role of inhaled corticosteroids to suppress nitric oxide gas exchange in stable patients with moderate-to-severe COPD who are current non-smokers and not on oral corticosteroids. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- fluticasone 100mcg/ salmeterol 50mcg, fluticasone 250/salmeterol 50 and salmeterol
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Oct 2013
- Phase
- Observational
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD
Who may be able to join
- Clinical diagnosis of copd
- Current non-smoker
- Not on oral corticosteroids
- Must be able to use Advair discus or salmeterol discus
Who cannot join
- Pregnancy
- Current smoker
- On corticosteroids
- Clinically unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Varying Doses of Inhaled Corticosteroids on Suppression of Total Exhaled, Bronchial, and Alveolar Nitric Oxide as Markers of Endogenous Inflammation in Patients With Moderate-to-severe COPD
To evaluate the role of inhaled corticosteroids to suppress nitric oxide gas exchange in stable patients with moderate-to-severe COPD who are current non-smokers and not on oral corticosteroids.
Read the detailed description
Stable, non-smoking COPD patients not on oral corticosteroids will be randomized in single blinded study to evaluate nitric oxide gas exchange at baseline, and subsequent effects of fluticasone 100mcg/salmeterol 50mcg bid, and fluticasone 250mcg/salmeterol 50mcg bid. Primary end points will include measurements of nitric oxide at varying expiratory flow rates to calculate bronchial, and small airway/alveolar nitric oxide. Secondary end points will evaluate lung function. Exhaled nitric oxide production presumably reflects endogenous inflammation. Normal healthy, non-smoking controls will be used for comparison, with exhaled nitric oxide measured before and after 3 weeks of low dose inhlaed corticosteroids.
- Conditions
- COPD
- Being tested
- fluticasone 100mcg/ salmeterol 50mcg, fluticasone 250/salmeterol 50, salmeterol, salmeterol and fluticasone propionate
- Keywords
- chronic airflow obstruction
- 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.
fluticasone 100mcg/ salmeterol 50mcgDrug
Also called Advair 100/50
inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months
fluticasone 250/salmeterol 50Drug
Also called Advair 250/50
inhaled fluticasone 250/salmeterol 50 X 3 months to evaluate effect on lung function and exhaled nitric oxide
salmeterolDrug
Also called Serevent 50mcg
salmeterol 50 mcg by dry powder inhaler disk bid to evaluated effect on lung function and exhaled nitric oxide
SalmeterolDrug
Also called serevent 50 mcg disk
salmeterol 50mcg bid X 3months
salmeterol and fluticasone propionateDrug
Also called Advair 250/50
salmeterol 50mcg/fluticasone 250mcg by DPI bid
| Study group | Role | What they receive |
|---|---|---|
| long acting bronchodilator | salmeterol 50mcg bid by DPI, no fluticasone in patients with COPD/emphysema to evaluate effect on bronchodilation and exhaled nitric oxide Receives: Drug: Salmeterol | |
| bronchodilator/ inhaled corticosteroid | fluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide Receives: Drug: fluticasone 250/salmeterol 50; Drug: salmeterol and fluticasone propionate | |
| C | Fluticasone 100mcg/salmeterol 50mcg Receives: Drug: fluticasone 100mcg/ salmeterol 50mcg; Drug: salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
total exhaled, bronchial, and small airway/alveolar nitric oxide
Measured: 3 months
Secondary outcomes (1)
lung function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startJan 2006
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthur F Gelb MD
- Responsible party
- Sponsor-investigator, Arthur F Gelb MD, Gelb, Arthur F., M.D.
- Investigators
- Arthur F Gelb, MD, Principal investigator, Arthur F Gelb Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568347
- Sponsor's protocol ID
- 20061697A
- Status last verified
- Mar 2015
- First submitted
- 4 Dec 2007
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gelb AF, Flynn Taylor C, Shinar C. Nitric Oxide gas exchange in COPD. Am J Respir Crit Care Med 2007; 174: A630.
Gelb AF, George SC, Camacho F, Fraser C, Flynn Taylor C, Shakkottai S. Increased nitric oxide concentrations in the small airway of older normal subjects. Chest. 2011 Feb;139(2):368-375. doi: 10.1378/chest.10-1157. Epub 2010 Aug 12.
PubMed 20705799Gelb AF, Flynn Taylor C, Krishnan A, Fraser C, Shinar CM, Schein MJ, Osann K. Central and peripheral airway sites of nitric oxide gas exchange in COPD. Chest. 2010 Mar;137(3):575-84. doi: 10.1378/chest.09-1522. Epub 2009 Oct 9.
PubMed 19820080
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Varying Doses of Inhaled Corticosteroids on Suppression of Total Exhaled, Bronchial, and Alveolar Nitric Oxide as Markers of Endogenous Inflammation in Patients With Moderate-to-severe COPD
- ClinicalTrials.gov ID
- NCT00568347
- Acronym / sponsor ID
- 20061697A
- Conditions
- COPD
- Keywords
- chronic airflow obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Arthur F Gelb MD
- Study start
- Jan 2006
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Dec 2007 (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.
To evaluate the role of inhaled corticosteroids to suppress nitric oxide gas exchange in stable patients with moderate-to-severe COPD who are current non-smokers and not on oral corticosteroids.
Detailed description
Stable, non-smoking COPD patients not on oral corticosteroids will be randomized in single blinded study to evaluate nitric oxide gas exchange at baseline, and subsequent effects of fluticasone 100mcg/salmeterol 50mcg bid, and fluticasone 250mcg/salmeterol 50mcg bid. Primary end points will include measurements of nitric oxide at varying expiratory flow rates to calculate bronchial, and small airway/alveolar nitric oxide. Secondary end points will evaluate lung function. Exhaled nitric oxide production presumably reflects endogenous inflammation. Normal healthy, non-smoking controls will be used for comparison, with exhaled nitric oxide measured before and after 3 weeks of low dose inhlaed corticosteroids.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| long acting bronchodilator | – | Drug: Salmeterolsalmeterol 50mcg bid by DPI, no fluticasone in patients with COPD/emphysema to evaluate effect on bronchodilation and exhaled nitric oxide |
| bronchodilator/ inhaled corticosteroid | – | Drug: fluticasone 250/salmeterol 50, Drug: salmeterol and fluticasone propionatefluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide |
| C | – | Drug: fluticasone 100mcg/ salmeterol 50mcg, Drug: salmeterolFluticasone 100mcg/salmeterol 50mcg |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD
Key inclusion criteria (4 listed)
- Clinical diagnosis of copd
- Current non-smoker
- Not on oral corticosteroids
- Must be able to use Advair discus or salmeterol discus
Key exclusion criteria (4 listed)
- Pregnancy
- Current smoker
- On corticosteroids
- Clinically unstable
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 |
|---|---|---|
| fluticasone 100mcg/ salmeterol 50mcgAlso: Advair 100/50inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months | Drug | C |
| fluticasone 250/salmeterol 50Also: Advair 250/50inhaled fluticasone 250/salmeterol 50 X 3 months to evaluate effect on lung function and exhaled nitric oxide | Drug | bronchodilator/ inhaled corticosteroid |
| salmeterolAlso: Serevent 50mcgsalmeterol 50 mcg by dry powder inhaler disk bid to evaluated effect on lung function and exhaled nitric oxide | Drug | C |
| SalmeterolAlso: serevent 50 mcg disksalmeterol 50mcg bid X 3months | Drug | long acting bronchodilator |
| salmeterol and fluticasone propionateAlso: Advair 250/50salmeterol 50mcg/fluticasone 250mcg by DPI bid | Drug | bronchodilator/ inhaled corticosteroid |
Primary outcome
total exhaled, bronchial, and small airway/alveolar nitric oxide
Time frame: 3 months
1 secondary outcome
lung function
Time frame: 3 months
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 17 Mar 2015.
- Results publicationGelb AF, Flynn Taylor C, Shinar C. Nitric Oxide gas exchange in COPD. Am J Respir Crit Care Med 2007; 174: A630.
- Derived from this study: PubMed 20705799Gelb AF, George SC, Camacho F, Fraser C, Flynn Taylor C, Shakkottai S. Increased nitric oxide concentrations in the small airway of older normal subjects. Chest. 2011 Feb;139(2):368-375. doi: 10.1378/chest.10-1157. Epub 2010 Aug 12.
- Derived from this study: PubMed 19820080Gelb AF, Flynn Taylor C, Krishnan A, Fraser C, Shinar CM, Schein MJ, Osann K. Central and peripheral airway sites of nitric oxide gas exchange in COPD. Chest. 2010 Mar;137(3):575-84. doi: 10.1378/chest.09-1522. Epub 2009 Oct 9.
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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.
Arthur F Gelb, MD principal investigator
Arthur F Gelb Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Arthur F Gelb MD 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 4 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 17 Mar 2015. 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 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 exhaled, bronchial, and small airway/alveolar nitric oxide (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00568347, which also lists 3 linked publications.
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 17 Mar 2015.