Pulmonary Disease, Chronic ObstructivePhase 4TAExaCOPNCT00952861
Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Doxycycline in people with Pulmonary Disease, Chronic Obstructive, run by Odense University Hospital at 1 site in Denmark.
Trial summary
It is not clear whether antibiotic therapy is needed in patients with mild to moderate exacerbation of chronic obstructive lung disease. The aim of the study is to compare the effect of 1 day of treatment with 6 days of treatment in patients who are admitted to hospital and being clinical stable (as judged by their… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Doxycycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Dec 2010
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 50 years
- History of smoking
- History of COPD
- Antibiotics for 24 hours
- At least 2 of the following: dyspnoea, coughing with sputum, and sputum with purulence
- Informed consent
Who cannot join
- Pneumonia
- Antibiotics for more than 36 hours
- Antibiotics for other infection
- Prednisolone, more than 0.5 mg/kg body weight/24 hours for more than 3 days
- Malignancy
- Other pulmonary disease
Show all 12Show fewer
- Immune deficiency
- Not able to tolerate doxycycline
- Severe heart, liver or kidney disease
- Epilepsia
- Not stable 24 hours after hospital admission
- Need for assisted ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibiotic Treatment of Patients Admitted to Hospital With Acute Exacerbation of COPD. Effect of 1 Day of Antibiotic Therapy Compared to 6 Days of Therapy in Patients Who Are Stable After 24 Hours
It is not clear whether antibiotic therapy is needed in patients with mild to moderate exacerbation of chronic obstructive lung disease. The aim of the study is to compare the effect of 1 day of treatment with 6 days of treatment in patients who are admitted to hospital and being clinical stable (as judged by their physician) 24 hours after hospitalization
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Doxycycline, Placebo (matching)
- Keywords
- Chronic obstructive pulmonary disease, Infection, Antibiotics
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
200 mg QD in 5 days
Placebo (matching)Drug
Placebo QD i 5 days
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Active comparator | Doxycycline 200 mg QD in 5 days Receives: Drug: Doxycycline |
| Placebo | Placebo comparator | Matching placebo QD i 5 days Receives: Drug: Placebo (matching) |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walking distance
Measured: Day 14
Secondary outcomes (1)
Time to next episode of acute exacerbation
Measured: Days 14, 30, 90 and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010 (estimated)
- Study completionDec 2010 (estimated)
Why it stopped: Stopped due to poor recruitment
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 Odense University HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kolding Sygehus, Svendborg Hospital, Fredericia Hospital, Naestved Hospital, Hillerod Hospital, Denmark, Region Syddanmark, Danmarks Lungeforening, Danish National Research Foundation
- Investigators
- Court Pedersen, MD, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952861
- Sponsor's protocol ID
- OUH-INF-1
- Acronym
- TAExaCOP
- Status last verified
- Jun 2010
- First submitted
- 24 Jul 2009
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Treatment of Patients Admitted to Hospital With Acute Exacerbation of COPD. Effect of 1 Day of Antibiotic Therapy Compared to 6 Days of Therapy in Patients Who Are Stable After 24 Hours
- ClinicalTrials.gov ID
- NCT00952861
- Acronym / sponsor ID
- TAExaCOP / OUH-INF-1
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic obstructive pulmonary disease, Infection, Antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stopped due to poor recruitment
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Kolding Sygehus, Svendborg Hospital, Fredericia Hospital, Naestved Hospital, Hillerod Hospital, Denmark, Region Syddanmark, Danmarks Lungeforening, Danish National Research Foundation
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 6 Aug 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.
It is not clear whether antibiotic therapy is needed in patients with mild to moderate exacerbation of chronic obstructive lung disease. The aim of the study is to compare the effect of 1 day of treatment with 6 days of treatment in patients who are admitted to hospital and being clinical stable (as judged by their physician) 24 hours after hospitalization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Active comparator | Drug: DoxycyclineDoxycycline 200 mg QD in 5 days |
| Placebo | Placebo comparator | Drug: Placebo (matching)Matching placebo QD i 5 days |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 50 years
- History of smoking
- History of COPD
- Antibiotics for 24 hours
- At least 2 of the following: dyspnoea, coughing with sputum, and sputum with purulence
Key exclusion criteria (12 listed)
- Pneumonia
- Antibiotics for more than 36 hours
- Antibiotics for other infection
- Prednisolone, more than 0.5 mg/kg body weight/24 hours for more than 3 days
- Malignancy
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 |
|---|---|---|
| Doxycycline200 mg QD in 5 days | Drug | Doxycycline |
| Placebo (matching)Placebo QD i 5 days | Drug | Placebo |
Primary outcome
6 minutes walking distance
Time frame: Day 14
1 secondary outcome
Time to next episode of acute exacerbation
Time frame: Days 14, 30, 90 and 180
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
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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.
Court Pedersen, MD study chair
Odense University Hospital
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 Doxycycline in people with Pulmonary Disease, Chronic Obstructive, run by Odense University Hospital at 1 site in Denmark.
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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 11 Aug 2010. 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 Denmark. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
6 minutes walking distance (time frame: Day 14). 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 Aug 2010.