Chronic BronchitisNCT00454675
Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis
An observational study of Chronic Bronchitis and COPD, run by Westside Family Medical Center, P.C. at 1 site in United States.
Trial summary
To determine whether an average population of males and females who smoke 10 pack years or more of cigarettes in a primary care setting with chronic bronchitis has already developed significant changes on pulmonary function testing. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Bronchitis, COPD
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Aug 2008
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care
Who may be able to join
- Subjects must sign a written informed consent.
- Enrollment population would include males and females 40 years of age to 80 years of age.
- Current history or past history of smoking at least 10 pack years of cigarettes.
- Patients to satisfy the diagnosis of chronic bronchitis.
- Non-smokers will be allowed in the control group
Who cannot join
- Chronic infections such as TB or other infections of the lungs.
- Collagen diseases such as rheumatoid arthritis or lupus which affect the lungs.
- Any previous lung diseases such as pneumoconiosis.
- Previous accidents or surgery which would involve the lungs or the ribcage.
- Maintenance medications used for asthma or COPD such as long acting bronchodilators or inhaled corticosteroids.
- Asthma patients or other patients with allergies that may affect pulmonary function test will be excluded.
Show all 9Show fewer
- Any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment.
- Pregnant woman will not be allowed
- Current participation in a research study or within the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, 49009
About this study
To determine whether an average population of males and females who smoke 10 pack years or more of cigarettes in a primary care setting with chronic bronchitis has already developed significant changes on pulmonary function testing.
Read the detailed description
The incident of COPD is dramatically increasing while other chronic disease states are decreasing in the US population. Smoking cigarettes is the leading risk factor for COPD. Smokers with chronic bronchitis may show early or late changes of COPD on pulmonary function tests. It is imperative that we define this patient population to determine whether early intervention will alter pulmonary function over the years.
- Conditions
- Chronic Bronchitis, COPD
- Keywords
- Smokers, Chronic Bronchitis, Pulmonary Function Test Abnormalities, COPD
- Medical subject headings
- Bronchitis, Chronic, Pulmonary Disease, Chronic Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2007 (estimated)
- Study startMar 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic BronchitisStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Westside Family Medical Center, P.C.
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Gary E Ruoff, MD, Principal investigator, Westside Family Medical Center, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454675
- Sponsor's protocol ID
- COPD-2006-01
- Status last verified
- Jun 2008
- First submitted
- 30 Mar 2007
- Last updated
- 15 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT00454675
- Acronym / sponsor ID
- COPD-2006-01
- Conditions
- Chronic Bronchitis, COPD
- Keywords
- Smokers, Chronic Bronchitis, Pulmonary Function Test Abnormalities, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Westside Family Medical Center, P.C.University, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2007
- Study completion
- Aug 2008 (actual)
- First posted
- 2 Apr 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 determine whether an average population of males and females who smoke 10 pack years or more of cigarettes in a primary care setting with chronic bronchitis has already developed significant changes on pulmonary function testing.
Detailed description
The incident of COPD is dramatically increasing while other chronic disease states are decreasing in the US population. Smoking cigarettes is the leading risk factor for COPD. Smokers with chronic bronchitis may show early or late changes of COPD on pulmonary function tests. It is imperative that we define this patient population to determine whether early intervention will alter pulmonary function over the years.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care
Key inclusion criteria (5 listed)
- Subjects must sign a written informed consent.
- Enrollment population would include males and females 40 years of age to 80 years of age.
- Current history or past history of smoking at least 10 pack years of cigarettes.
- Patients to satisfy the diagnosis of chronic bronchitis.
- Non-smokers will be allowed in the control group
Key exclusion criteria (9 listed)
- Chronic infections such as TB or other infections of the lungs.
- Collagen diseases such as rheumatoid arthritis or lupus which affect the lungs.
- Any previous lung diseases such as pneumoconiosis.
- Previous accidents or surgery which would involve the lungs or the ribcage.
- Maintenance medications used for asthma or COPD such as long acting bronchodilators or inhaled corticosteroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 15 Aug 2008.
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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.
Gary E Ruoff, MD principal investigator
Westside Family Medical Center, P.C.
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 Chronic Bronchitis and COPD, run by Westside Family Medical Center, P.C. 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 5 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: finished, as of the sponsor's last update on 15 Aug 2008. 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.
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 15 Aug 2008.