Pulmonary Disease, Chronic ObstructivePhase 4NCT00184977
COPD on Primary Care Treatment (COOPT)
A Phase 4 study testing N-acetylcysteine and fluticasone propionate in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Obstructive, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
The aim of this family practice based study is to determine the long-term treatment effects of two drugs that are presumed to modify the course and progression of chronic obstructive pulmonary disease (COPD), oral N-acetylcysteine and inhaled corticosteroids. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Bronchitis, Chronic
- What is being tested?
- N-acetylcysteine and fluticasone propionate
- How many people
- 270 participants
- Where
- 2 sitesNetherlands
- Study dates
- Dec 1998to Jan 2003
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 30 and 75 years
- being a smoker or ex-smoker
- post-bronchodilator FEV1/FVC ratio is <88% of the predicted value in case of men or <89% of the predicted value in case of women
- post-bronchodilator FEV1>=40% and <90% of the predicted value
- subjects have a GP diagnosis of COPD or had increased cough, sputum and/or dyspnea on most days for 3 or more months a year, for at least the last 2 years
- able to provide a written informed consent
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- expected to be able to comply with the study protocol
- able to communicate with the study personnel and to understand and read instructions
- females of childbearing potential should use an acceptable method for birth control
Who cannot join
- a known history of intolerance or allergy for N-acetylcysteine or fluticason
- use of long-term oxygen therapy or expected to be in need of oxygen therapy within the next 3 years
- registered asthma, allergic rhinitis, and/or allergic eczema as an active problem in the GPs records within the last 12 months
- alpha1-antitrypsin deficiency
- cystic fibrosis
- active infection due to Mycobacterium tuberculosis
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- status post-lobectomy
- clinically proven gastric or duodenal ulcer in the previous six months
- non-compensated severe chronic congestive heart failure
- life expectancy reduction (e.g. malignancies)
- evidence of illicit drug use or abuse of alcohol intake
- expected not to be compliant in taking medications in general
- being pregnant or giving breastfeeding
- not complying with the inclusion criteria
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Department of Family Medicine, University of Maastricht
Maastricht, 6200 MD
Department of Family Medicine, Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
Official title: A Double-blind Placebo-controlled Trial Comparing the Efficacy and Cost-effectiveness of Inhaled Fluticason Propionate Versus Oral N-acetylcysteine in the Treatment of Patients With COPD in General Practice
The aim of this family practice based study is to determine the long-term treatment effects of two drugs that are presumed to modify the course and progression of chronic obstructive pulmonary disease (COPD), oral N-acetylcysteine and inhaled corticosteroids.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a disorder characterised by symptoms and abnormal tests of expiratory flow that do not change markedly over periods of several months observation. COPD includes chronic bronchitis and emphysema. It is not fully clear which medication is the most efficacious in the long-term treatment of COPD. In contrast to asthma, the efficacy and therefore the precise role of inhaled corticosteroids is less clear in the treatment of patients with COPD. The same applies to another (much less investigated) possibility in the treatment of COPD, the anti-oxidant agent N-acetylcysteine. N-acetylcysteine is used as a mucolytic agent in a variety of clinical conditions, such as acute and chronic bronchitis and cystic fibrosis. The aim of this study, which is performed in family practices, is to determine the 3-year treatment effects and cost-effectiveness of oral N-acetylcysteine versus an inhaled corticosteroid (fluticason propionate) in modifying the course and progression of COPD.
Comparisons: N-acetylcysteine (oral, 600 mg o.d.) and fluticason propionate (dry powder inhalation, 500 mcg b.i.d.) are compared with placebo
- Being tested
- N-acetylcysteine, fluticasone propionate
- Keywords
- Pulmonary Disease, Chronic Obstructive, Randomized Controlled Trial, Family Practice, Respiratory Function Tests, Health Status
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
fluticasone propionateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
exacerbations of COPD, condition-specific quality of life
Secondary outcomes (1)
lung function decline, respiratory symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 1998
- Study completionJan 2003
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.
- More trials run by Radboud University Medical CenterThe 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 270 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Health Care Insurance Board, GlaxoSmithKline, Zambon SpA, The Netherlands Asthma Foundation
- Investigators
- Tjard RJ Schermer, MSc, PhD, Principal investigator, Radboud University Nijmegen Medical Centre, Department of Family MedicineChris van Weel, MD, PhD, Study director, Radboud University Nijmegen Medical Centre, Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184977
- Sponsor's protocol ID
- 98-46140
- Other IDs
- 95093 FLU9802 NAC-NL-11
- Status last verified
- Aug 2006
- First submitted
- 12 Sep 2005
- Last updated
- 12 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Placebo-controlled Trial Comparing the Efficacy and Cost-effectiveness of Inhaled Fluticason Propionate Versus Oral N-acetylcysteine in the Treatment of Patients With COPD in General Practice
- ClinicalTrials.gov ID
- NCT00184977
- Acronym / sponsor ID
- 98-46140
- Keywords
- Pulmonary Disease, Chronic Obstructive, Randomized Controlled Trial, Family Practice, Respiratory Function Tests, Health Status
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Health Care Insurance Board, GlaxoSmithKline, Zambon SpA, The Netherlands Asthma Foundation
- Study start
- Dec 1998
- Study completion
- Jan 2003
- First posted
- 16 Sep 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 aim of this family practice based study is to determine the long-term treatment effects of two drugs that are presumed to modify the course and progression of chronic obstructive pulmonary disease (COPD), oral N-acetylcysteine and inhaled corticosteroids.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a disorder characterised by symptoms and abnormal tests of expiratory flow that do not change markedly over periods of several months observation. COPD includes chronic bronchitis and emphysema. It is not fully clear which medication is the most efficacious in the long-term treatment of COPD. In contrast to asthma, the efficacy and therefore the precise role of inhaled corticosteroids is less clear in the treatment of patients with COPD. The same applies to another (much less investigated) possibility in the treatment of COPD, the anti-oxidant agent N-acetylcysteine. N-acetylcysteine is used as a mucolytic agent in a variety of clinical conditions, such as acute and chronic bronchitis and cystic fibrosis. The aim of this study, which is performed in family practices, is to determine the 3-year treatment effects and cost-effectiveness of oral N-acetylcysteine versus an inhaled corticosteroid (fluticason propionate) in modifying the course and progression of COPD.
Comparisons: N-acetylcysteine (oral, 600 mg o.d.) and fluticason propionate (dry powder inhalation, 500 mcg b.i.d.) are compared with placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age between 30 and 75 years
- being a smoker or ex-smoker
- post-bronchodilator FEV1/FVC ratio is <88% of the predicted value in case of men or <89% of the predicted value in case of women
- post-bronchodilator FEV1>=40% and <90% of the predicted value
- subjects have a GP diagnosis of COPD or had increased cough, sputum and/or dyspnea on most days for 3 or more months a year, for at least the last 2 years
Key exclusion criteria (14 listed)
- a known history of intolerance or allergy for N-acetylcysteine or fluticason
- use of long-term oxygen therapy or expected to be in need of oxygen therapy within the next 3 years
- registered asthma, allergic rhinitis, and/or allergic eczema as an active problem in the GPs records within the last 12 months
- alpha1-antitrypsin deficiency
- cystic fibrosis
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 |
|---|---|---|
| N-acetylcysteine | Drug | – |
| fluticasone propionate | Drug | – |
Primary outcome
exacerbations of COPD, condition-specific quality of life
1 secondary outcome
lung function decline, respiratory symptoms
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 12 Mar 2010.
- Department of General Practice/Family Medicine, Radboud University Nijmegen Medical CentreLink provided by the sponsor.
- Netherlands Asthma FoundationLink provided by the sponsor.
- GlaxoSmithKline (study sponsor)Link provided by the sponsor.
- Zambon Group Spa (Study Sponsor)Link provided by the sponsor.
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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.
Tjard RJ Schermer, MSc, PhD principal investigator
Radboud University Nijmegen Medical Centre, Department of Family Medicine
Chris van Weel, MD, PhD study director
Radboud University Nijmegen Medical Centre, Department of Family Medicine
2 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 N-acetylcysteine and fluticasone propionate in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Obstructive, run by Radboud University Medical Center at 2 sites in Netherlands.
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 9 inclusion and 14 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 12 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
exacerbations of COPD, condition-specific quality of life. 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 12 Mar 2010.