COPDPhase 4NCT00995475
A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Fluticasone propionate in people with COPD, run by University of Dundee.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers are now an established treatment for COPD. Inhaled steroids can have a number of bad effects including suppression of the adrenal glands because of absorption. A previous study in patients with COPD. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- COPD
- What is being tested?
- Fluticasone propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Nov 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current or ex-smokers
- Aged over 50years
- FEV1/FVC ratio <0.7
- FEV1<80% predicted
- Improvement in FEV1 following short acting beta-agonist not greater than 15% and 200ml.
Who cannot join
- Diagnosis of asthma, bronchiectasis or ABPA
- Inability to perform study procedures or give informed consent
- Known sensitivity to trial medications
About this study
Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers are now an established treatment for COPD. Inhaled steroids can have a number of bad effects including suppression of the adrenal glands because of absorption. A previous study in patients with COPD.
C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation. Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP have also been found in patients with COPD. In some studies, steroid inhalers have reduced CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown whether this reflects a reduction in lung inflammation or an effect of systemically absorbed corticosteroid.
It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.
- Conditions
- COPD
- Being tested
- Fluticasone propionate, Placebo
- 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 propionateDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Inhaled corticosteroid, Then placebo | Experimental | FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. After a washout period of 2 weeks, they then received FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. Receives: Drug: Fluticasone propionate; Drug: Placebo |
| Placebo control, Then inhaled corticosteroid | Placebo comparator | FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. After a washout period of 2 weeks, they then received FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. Receives: Drug: Fluticasone propionate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP
C-reactive protein
Measured: 4 weeks
Secondary outcomes (2)
Alveolar Nitric Oxide
Measured: 4 weeks
OUCC
Overnight urinary cortisol creatinine ratio
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startOct 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995475
- Sponsor's protocol ID
- MEN001
- Status last verified
- Apr 2019
- First submitted
- 14 Oct 2009
- Last updated
- 19 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Williamson PA, Menzies D, Clearie KL, Vaidyanathan S, Lipworth BJ. Dose-response for inhaled fluticasone on airway and systemic inflammation in COPD. Eur Respir J. 2011 Jan;37(1):206-9. doi: 10.1183/09031936.00062210. No abstract available.
PubMed 21205715
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00995475
- Acronym / sponsor ID
- MEN001
- Conditions
- COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 15 Oct 2009 (estimated)
- Results
- Posted 9 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers are now an established treatment for COPD. Inhaled steroids can have a number of bad effects including suppression of the adrenal glands because of absorption. A previous study in patients with COPD.
C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation. Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP have also been found in patients with COPD. In some studies, steroid inhalers have reduced CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown whether this reflects a reduction in lung inflammation or an effect of systemically absorbed corticosteroid.
It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled corticosteroid, Then placebo | Experimental | Drug: Fluticasone propionate, Drug: PlaceboFP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. After a washout period of 2 weeks, they then received FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. |
| Placebo control, Then inhaled corticosteroid | Placebo comparator | Drug: Fluticasone propionate, Drug: PlaceboFP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. After a washout period of 2 weeks, they then received FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current or ex-smokers
- Aged over 50years
- FEV1/FVC ratio <0.7
- FEV1<80% predicted
- Improvement in FEV1 following short acting beta-agonist not greater than 15% and 200ml.
Key exclusion criteria (3 listed)
- Diagnosis of asthma, bronchiectasis or ABPA
- Inability to perform study procedures or give informed consent
- Known sensitivity to trial medications
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 propionate | Drug | Inhaled corticosteroid, Then placebo, Placebo control, Then inhaled corticosteroid |
| Placebo | Drug | Inhaled corticosteroid, Then placebo, Placebo control, Then inhaled corticosteroid |
Primary outcome
CRP
Time frame: 4 weeks
C-reactive protein
2 secondary outcomes
Alveolar Nitric Oxide
Time frame: 4 weeks
OUCC
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21205715Williamson PA, Menzies D, Clearie KL, Vaidyanathan S, Lipworth BJ. Dose-response for inhaled fluticasone on airway and systemic inflammation in COPD. Eur Respir J. 2011 Jan;37(1):206-9. doi: 10.1183/09031936.00062210. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone propionate in people with COPD, run by University of Dundee.
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 3 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 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CRP (time frame: 4 weeks). 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 NCT00995475, which also lists 1 linked publication.
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 May 2023.