Chronic Obstructive Pulmonary DiseasePhase 4NCT00405236
Effect of Tiotropium on Inflammation and Exacerbations in COPD
A Phase 4 study testing tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Royal Free and University College Medical School at 1 site in United Kingdom.
Trial summary
Patients with COPD experience exacerbations that are a major cause of morbidity. Exacerbations are associated with increased airway and systemic inflammation and those experiencing frequent exacerbations demonstrate increased inflammation in the stable state. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- tiotropium
- How many people
- 220 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2002to Jan 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of COPD,
- FEV1 < 80% predicted,
- minimum 10 pack year smoking history
Who cannot join
- asthma,
- atopic disease,
- eosinophilia,
- history of malignancy,
- history of clinically significant pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Changes in Inflammatory Markers in Induced Sputum Following Treatment With Tiotropium Inhalation Capsules 18mcg Once Daily in Patients With Chronic Obstructive Pulmonary Disease
Patients with COPD experience exacerbations that are a major cause of morbidity. Exacerbations are associated with increased airway and systemic inflammation and those experiencing frequent exacerbations demonstrate increased inflammation in the stable state. Tiotropium has been shown to reduce exacerbation frequency and it might be postulated that this is due to a reduction in inflammation. The study will compare airway inflammation and exacerbation frequency in patients with COPD on tiotropium or placebo.
Read the detailed description
Patients with COPD will be randomised to tiotropium or placebo in addition to their usual medication. They will be followed prospectively over 1 year and provide sputum for quantification of IL-6 and IL-8 at baseline and at 3 monthly intervals.Serum IL-6 will also be quantified at baseline and over the year. Changes in inflammatory markers will be assessed by analysis of area under the curve of log transformed data. Exacerbation frequency will be calculated from patient diary cards using a previously validated symptom-based exacerbation definition.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- tiotropium
- Keywords
- inflammation, exacerbations
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tiotropiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
sputum IL-6
Secondary outcomes (7)
sputum IL-8
sputum MPO
serum IL-6
serum CRP
exacerbation frequency
FEV1
FVC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2006 (estimated)
- Study startOct 2002
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Royal Free and University College Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Investigators
- Jadwiga A Wedzicha, MD, Principal investigator, Academic Unit of Respiratory Medicine, Royal Free and University College Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405236
- Sponsor's protocol ID
- 205.270
- Status last verified
- Nov 2006
- First submitted
- 27 Nov 2006
- Last updated
- 29 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Changes in Inflammatory Markers in Induced Sputum Following Treatment With Tiotropium Inhalation Capsules 18mcg Once Daily in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00405236
- Acronym / sponsor ID
- 205.270
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- inflammation, exacerbations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- Royal Free and University College Medical SchoolUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Oct 2002
- Study completion
- Jan 2005
- First posted
- 29 Nov 2006 (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.
Patients with COPD experience exacerbations that are a major cause of morbidity. Exacerbations are associated with increased airway and systemic inflammation and those experiencing frequent exacerbations demonstrate increased inflammation in the stable state. Tiotropium has been shown to reduce exacerbation frequency and it might be postulated that this is due to a reduction in inflammation. The study will compare airway inflammation and exacerbation frequency in patients with COPD on tiotropium or placebo.
Detailed description
Patients with COPD will be randomised to tiotropium or placebo in addition to their usual medication. They will be followed prospectively over 1 year and provide sputum for quantification of IL-6 and IL-8 at baseline and at 3 monthly intervals.Serum IL-6 will also be quantified at baseline and over the year. Changes in inflammatory markers will be assessed by analysis of area under the curve of log transformed data. Exacerbation frequency will be calculated from patient diary cards using a previously validated symptom-based exacerbation definition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of COPD,
- FEV1 < 80% predicted,
- minimum 10 pack year smoking history
Key exclusion criteria (5 listed)
- asthma,
- atopic disease,
- eosinophilia,
- history of malignancy,
- history of clinically significant pulmonary disease
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 |
|---|---|---|
| tiotropium | Drug | – |
Primary outcome
sputum IL-6
7 secondary outcomes
sputum IL-8
sputum MPO
serum IL-6
serum CRP
exacerbation frequency
FEV1
FVC
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 29 Nov 2006.
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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.
Jadwiga A Wedzicha, MD principal investigator
Academic Unit of Respiratory Medicine, Royal Free and University College Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Royal Free and University College Medical School at 1 site in United Kingdom.
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 3 inclusion and 5 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 29 Nov 2006. 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 Kingdom. 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?
sputum IL-6. 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 Nov 2006.