Chronic Obstructive Pulmonary DiseasePhase 3NCT00826163
Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 3 study testing Budesonide in people with Chronic Obstructive Pulmonary Disease, run by Mahidol University at 1 site in Thailand.
Trial summary
We hypothesize that ongoing and more severe airway inflammation in COPD may result from the impairment in activation of innate immune response Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2009to Dec 2009
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of COPD or asthma
- a ratio of prebronchodilator FEV1 to forced vital capacity (FVC) equal to or less than 0.70
- postbronchodilator FEV1 > or = 50% predicted
Who cannot join
- Exacerbation
- systemic corticosteroids
- DM, HIV and autoimmune disease
- immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innate Immune Responses in Chronic Obstructive Pulmonary Disease Patients
We hypothesize that ongoing and more severe airway inflammation in COPD may result from the impairment in activation of innate immune response
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Budesonide
- 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.
BudesonideDrug
Also called Rhinocort
Inhaled budesonide 400 mcg twice a day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| stable COPD | Active comparator | Postbronchodilator FEV1> or = 50% predicted Receives: Drug: Budesonide |
| Asthma | Sham comparator | Postbronchodilator FEV1 > or = 50% predicted Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum IL-8, IL-17
Measured: 2 WEEKS
Secondary outcomes (1)
The expression of NF-kappa B in sputum macrophages
Measured: 2 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2009
- Study completionDec 2009
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.
- More trials run by Mahidol UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Development Agency, Thailand
- Responsible party
- Principal investigator, Kittipong Maneechotesuwan, Mahidol University
- Investigators
- Kittipong Maneechotesuwan, MD, PhD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826163
- Sponsor's protocol ID
- BT-B-01-MG-14-5114
- Status last verified
- Sep 2013
- First submitted
- 16 Dec 2008
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innate Immune Responses in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT00826163
- Acronym / sponsor ID
- BT-B-01-MG-14-5114
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Development Agency, Thailand
- Study start
- Jan 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Jan 2009 (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.
We hypothesize that ongoing and more severe airway inflammation in COPD may result from the impairment in activation of innate immune response
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stable COPD | Active comparator | Drug: BudesonidePostbronchodilator FEV1> or = 50% predicted |
| Asthma | Sham comparator | Drug: BudesonidePostbronchodilator FEV1 > or = 50% predicted |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of COPD or asthma
- a ratio of prebronchodilator FEV1 to forced vital capacity (FVC) equal to or less than 0.70
- postbronchodilator FEV1 > or = 50% predicted
Key exclusion criteria (4 listed)
- Exacerbation
- systemic corticosteroids
- DM, HIV and autoimmune disease
- immunosuppressive therapy
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 |
|---|---|---|
| BudesonideAlso: RhinocortInhaled budesonide 400 mcg twice a day for 2 weeks | Drug | Asthma, stable COPD |
Primary outcome
Sputum IL-8, IL-17
Time frame: 2 WEEKS
1 secondary outcome
The expression of NF-kappa B in sputum macrophages
Time frame: 2 WEEKS
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 11 Sep 2013.
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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.
Kittipong Maneechotesuwan, MD, PhD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide in people with Chronic Obstructive Pulmonary Disease, run by Mahidol University at 1 site in Thailand.
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 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 11 Sep 2013. 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 Thailand. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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-8, IL-17 (time frame: 2 WEEKS). 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 11 Sep 2013.