Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT02305940
Effects of Long Term Antibiotic Therapy on Exacerbation Rate in Stable COPD Patients
A Phase 3 study testing Doxycycline in people with Chronic Obstructive Pulmonary Disease (COPD), run by Imperial College London at 3 sites in United Kingdom.
Trial summary
This study investigates if long term use of the antibiotic doxycycline can reduce exacerbations in COPD patients. Half of the patients will receive doxycycline which the other half will receive a placebo. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jul 2014to 12 Jul 2017
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent given
- Confirmed COPD diagnosis
- Severity of disease: Patients with a measured FEV1<80% of predicted normal values.
- At least one treated exacerbation (Patient recalls an episode of symptomatic worsening which was treated and was consistent with a COPD exacerbation) in the previous year.
- Age: ≥ 45 years of age at screening.
- Able to complete questionnaires for health status and symptoms and considered able to comply with the dosing regimen.
- Patients willing to report exacerbations and attend for study visits.
Who cannot join
- Patients with a known diagnosis of active TB or other chronic respiratory disease in the judgement of the study doctor.
- Hepatic or renal impairment as defined as LFTs > 5XULN, and eGFR<30 ml/min/1.73m2.
- Patients with known hypersensitivity to Tetracyclines, the IMP and/or Placebo including their excipients.
- Patients taking ongoing antibiotic therapy for COPD or other conditions.
- Patients with uncontrolled clinically significant hypertension
- Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding.
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- Patients with uncontrolled clinically relevant bradycardia, cardiac arrhythmias or cardiac insufficiency.
- Clinically relevant abnormal electrolyes (sodium or potassium), renal function (urea and creatinine) or liver function (ALT, AST, ALP) that could interfere with the objectives of the trial or safety of the volunteer.
- Patient taking clinically significant contraindicated medication, as per the SmPC for Doxycycline.
- Use of another experimental investigational medicinal product within 3 months of study enrolment. If the IMP used was as part of the NIHR WP2 study then entry to WP3 after a 6 week washout period is permissible.
- Patients with any other condition precluding enrolment in the trial, according to the assessment of the study doctor. This will be documented at screening
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Aintree University Hospital NHS Foundation Trust
Liverpool, L9 7AL
St Georges University Hospitals NHS Foundation Trust
London, SW17 0RE
Royal Brompton and Harefield Hospital NHS Foundation Trust
London, SW36NP
About this study
Official title: A Phase III Double-blind, Randomised, Placebo Controlled Trial of Long Term Therapy on Exacerbation Rate in Patients With Stable COPD Using Doxycycline
This study investigates if long term use of the antibiotic doxycycline can reduce exacerbations in COPD patients. Half of the patients will receive doxycycline which the other half will receive a placebo.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a common disease which can place a considerable burden on people who suffer from it. COPD exacerbations (periods when symptoms flare up) are a major cause of hospital admission in the UK. Bacterial infections play an important role in the development of COPD and so one possible treatment for COPD is with antibiotics. However, there is little information available about the use of long term antibiotics in the treatment of this disease.
Therefore, the purpose of this study is to investigate if long term use of the antibiotic Doxycycline can reduce exacerbations and improve the outlook for these patients.
- Being tested
- Doxycycline, 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.
DoxycyclineDrug
An oral dose of 100 mg of Doxycycline once daily, for a total duration of 52 weeks.
PlaceboDrug
An oral dose of one capsule of placebo once daily, for a total duration of 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Active comparator | Doxycycline: oral dose of 100 mg once daily, for a total duration of 52 weeks. Receives: Drug: Doxycycline |
| Placebo | Placebo comparator | Placebo: an oral dose of one capsule once daily, for a total duration of 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of exacerbations (per person/year) recorded from date of drug issue until date of end of treatment visit.
Measured: 12 months
Secondary outcomes (10)
Lung function (spirometry) (FEV1, FVC, FEV1/FVC ratio, FEV1 as % Predicted).
Measured: 12 months of treatment
Total and individual component (symptoms, activity, impact) SGRQ scores will be used to measure health status.
Measured: 12 months of treatment
Respiratory health status across groups as measured from total number of symptoms in a day and prevalence of individual symptoms recorded on daily diary cards.
Measured: 12 months of treatment
Airway bacteria numbers taken from a sputum sample, provided by a subset of patients, at months 3, 6, 9, 12 after drug issue.
Measured: 12 months of treatment
Changes in C-reactive protein (CRP) levels from baseline.
Measured: 12 months of treatment
Hospital admissions. This data will be collected from Hospital Episode Statistics (HES).
Measured: 12 months of treatment
Time to 1st exacerbation measured by diary cards in both therapy and placebo groups.
Measured: 12 months of treatment
Rate of exacerbations treated with steroids and antibiotics.
Measured: 12 months of treatment
Adherence as measured using pill counts.
Measured: 12 months of treatment
Antibiotic resistance measured in the subset of patients (able to produce sputum) from sputum based on standard NHS procedures (not resistant, intermediate, severe, resistant).
Measured: 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startJul 2014
- Primary completion12 Jul 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wisia Wedzicha, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305940
- Sponsor's protocol ID
- 14IC2030
- Status last verified
- Apr 2017
- First submitted
- 20 Nov 2014
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Allinson JP, Vlies BH, Brill SE, Law M, Burnside G, Finney LJ, Alves-Moreira L, Donaldson GC, Calverley PMA, Walker PP, Wedzicha JA. A Double-Blind, Randomized, Placebo-controlled Trial of Long-Term Doxycycline Therapy on Exacerbation Rate in Patients with Stable Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2023 Sep 1;208(5):549-558. doi: 10.1164/rccm.202212-2287OC.
PubMed 37450935
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Double-blind, Randomised, Placebo Controlled Trial of Long Term Therapy on Exacerbation Rate in Patients With Stable COPD Using Doxycycline
- ClinicalTrials.gov ID
- NCT02305940
- Acronym / sponsor ID
- 14IC2030
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 3 Dec 2014 (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.
This study investigates if long term use of the antibiotic doxycycline can reduce exacerbations in COPD patients. Half of the patients will receive doxycycline which the other half will receive a placebo.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a common disease which can place a considerable burden on people who suffer from it. COPD exacerbations (periods when symptoms flare up) are a major cause of hospital admission in the UK. Bacterial infections play an important role in the development of COPD and so one possible treatment for COPD is with antibiotics. However, there is little information available about the use of long term antibiotics in the treatment of this disease.
Therefore, the purpose of this study is to investigate if long term use of the antibiotic Doxycycline can reduce exacerbations and improve the outlook for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Active comparator | Drug: DoxycyclineDoxycycline: oral dose of 100 mg once daily, for a total duration of 52 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: an oral dose of one capsule once daily, for a total duration of 52 weeks. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent given
- Confirmed COPD diagnosis
- Severity of disease: Patients with a measured FEV1<80% of predicted normal values.
- At least one treated exacerbation (Patient recalls an episode of symptomatic worsening which was treated and was consistent with a COPD exacerbation) in the previous year.
- Age: ≥ 45 years of age at screening.
Key exclusion criteria (11 listed)
- Patients with a known diagnosis of active TB or other chronic respiratory disease in the judgement of the study doctor.
- Hepatic or renal impairment as defined as LFTs > 5XULN, and eGFR<30 ml/min/1.73m2.
- Patients with known hypersensitivity to Tetracyclines, the IMP and/or Placebo including their excipients.
- Patients taking ongoing antibiotic therapy for COPD or other conditions.
- Patients with uncontrolled clinically significant hypertension
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 |
|---|---|---|
| DoxycyclineAn oral dose of 100 mg of Doxycycline once daily, for a total duration of 52 weeks. | Drug | Doxycycline |
| PlaceboAn oral dose of one capsule of placebo once daily, for a total duration of 52 weeks | Drug | Placebo |
Primary outcome
Rate of exacerbations (per person/year) recorded from date of drug issue until date of end of treatment visit.
Time frame: 12 months
10 secondary outcomes
Lung function (spirometry) (FEV1, FVC, FEV1/FVC ratio, FEV1 as % Predicted).
Time frame: 12 months of treatment
Total and individual component (symptoms, activity, impact) SGRQ scores will be used to measure health status.
Time frame: 12 months of treatment
Respiratory health status across groups as measured from total number of symptoms in a day and prevalence of individual symptoms recorded on daily diary cards.
Time frame: 12 months of treatment
Airway bacteria numbers taken from a sputum sample, provided by a subset of patients, at months 3, 6, 9, 12 after drug issue.
Time frame: 12 months of treatment
Changes in C-reactive protein (CRP) levels from baseline.
Time frame: 12 months of treatment
Hospital admissions. This data will be collected from Hospital Episode Statistics (HES).
Time frame: 12 months of treatment
Time to 1st exacerbation measured by diary cards in both therapy and placebo groups.
Time frame: 12 months of treatment
Rate of exacerbations treated with steroids and antibiotics.
Time frame: 12 months of treatment
Adherence as measured using pill counts.
Time frame: 12 months of treatment
Antibiotic resistance measured in the subset of patients (able to produce sputum) from sputum based on standard NHS procedures (not resistant, intermediate, severe, resistant).
Time frame: 12 months of treatment
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 26 Jul 2017.
- Derived from this study: PubMed 37450935Allinson JP, Vlies BH, Brill SE, Law M, Burnside G, Finney LJ, Alves-Moreira L, Donaldson GC, Calverley PMA, Walker PP, Wedzicha JA. A Double-Blind, Randomized, Placebo-controlled Trial of Long-Term Doxycycline Therapy on Exacerbation Rate in Patients with Stable Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2023 Sep 1;208(5):549-558. doi: 10.1164/rccm.202212-2287OC.
- Individual participant dataSharing planned: No
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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.
Wisia Wedzicha, MD principal investigator
Imperial College London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxycycline in people with Chronic Obstructive Pulmonary Disease (COPD), run by Imperial College London at 3 sites 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 7 inclusion and 11 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 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Rate of exacerbations (per person/year) recorded from date of drug issue until date of end of treatment visit. (time frame: 12 months). 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 NCT02305940, 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 26 Jul 2017.