EUCTR2012-002199-15-GBActive, not recruitingPhase 1
A Phase III double-blind, randomised, placebo controlled trial of long term therapy on Exacerbation Rate in patients with stable COPD using Doxycycline - Effects of Long Term Antibiotic Therapy on Exacerbation Rate in Stable COPD Patients
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Imperial College London
- Enrollment
- 222
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Patients eligible for enrolment in the study must meet all the following criteria:
- •Informed Consent: Patients must give their signed and dated written informed consent to participate
- •Confirmed COPD diagnosis (Post bronchodilator spirometry spirometry: FEV1/FVC<0.70 with at least a 10 pack year history of smoking )
- •Severity of disease: Only patients with a measured FEV1<80% of predicted normal values as determined at screening will be enrolled. Three spirometry readings will be taken to assess FEV1 and FVC. The highest reading of FEV1 and the highest reading of FVC will be used to calculate the FEV1/FVC ratio, and for comparison with the predicted normal value
- •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 who self-manage exacerbations must be willing to report these exacerbations and attend relevant exacerbation visits.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 172
Exclusion Criteria
- •Patients with known active TB or other clinically significant chronic respiratory disease (e.g. chronic asthma, bronchiectasis, pulmonary fibrosis) in the judgment of the study doctor.
- •Hepatic or renal impairment as defined as LFTs > 5XULN, and creatinine > 5 x ULN.
- •Patients with known hypersensitivity to 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.
- •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.
- •Females of childbearing potential must be willing to use an effective method of contraception from the time consent is signed until (6 weeks) after treatment discontinuation. These include:
- •Complete abstinence from screening to final visit
- •Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for the subject
- •Implants of levonorgestral inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion
- •Injectable progestogen administered for at least 1 month prior to study medication administration
- •Oral contraception (combined or progestogen only) administrated for at least one monthly cycle prior to study medication administration.
- •Double barrier methods: condoms or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/get/film/cream/suppository)
- •An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year
- •Estrogenic vaginal ring
- •Percutaneous contraceptive patches.
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to receiving trial treatment.
- •NOTE: Subjects are considered not of childbearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- •Females must not be breastfeeding.
Investigators
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