A Study to Test a Potential New Treatment for COPD Patients Suffering From the Common Cold or Influenza

Inclusion Criteria

• •1. Male or female, between and including 40-75 years of age, at the time of the screening visit.
• •2. A confirmed physician diagnosis of COPD or a medical history consistent with a diagnosis of COPD for at least 12 months prior to the screening visit.
• •3. Post-bronchodilator FEV1 ≥40% of predicted and FEV1/FVC ratio \<0.7 (at screening).
• •4. FEV1 ≥30% of predicted (at Visit 2, pre-dose).
• •5. Should have stable COPD, having no symptoms of an exacerbation and/or respiratory tract infection currently and/or within the past 6 weeks of screening and/or randomisation.
• •6. Should be prescribed and taking regularly one or more long acting bronchodilators (e.g. long acting β2 agonist \[LABA\], long acting muscarinic antagonist \[LAMA\]) with or without an inhaled corticosteroid maintenance therapy for their COPD.
• •7. Patients who produce sputum most days.
• •8. Provide written informed consent.
• •9. The patient produced an adequate sputum sample at the screening visit.
• •10. Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception. Women should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose. In addition to the acceptable birth control method (except for the practice of total sexual abstinence), condom (in UK with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose to prevent pregnancy.
• •Women of childbearing potential must have a negative pregnancy test at screening and prior to randomisation.
• •Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply:
• •* Women \<50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the postmenopausal range. If the FSH result is not available at the time of randomization, the patient must have a negative pregnancy test and agree to use highly effective contraception methods until the FSH result is available.
• •* Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
• •11. Motivation (in the Investigator's opinion) to comply with protocol requirements and complete all study visits, including the ability to communicate well with the Investigator and be capable of understanding the nature of the research and its treatment (including its risks and potential benefits).
• •1. Male or female, between and including 40-85 years of age at the time of the consent visit.
• •2. A confirmed physician diagnosis of COPD or a medical history consistent with a diagnosis of COPD for at least 12 months prior to the consent visit.
• •3. Current or ex-smoker with ≥ 10 pack years of smoking history.
• •4. Post bronchodilator FEV1/FVC ratio \<0.7.
• •5. Post bronchodilator FEV1 ≥40% of the predicted value. Once the safety data for the first 16 patients have been reviewed and approved by the DSMC the criterion will be changed to a post bronchodilator of FEV1 ≥30% of the predicted value\*.
• •6. To have had 1 or more COPD exacerbations in the last 12 months requiring intervention with oral corticosteroids and/or antibiotics.
• •7. Patient reported evidence that a respiratory virus has made their COPD significantly worse in the past.
• •8. Should be prescribed and taking regularly one or more long acting bronchodilator (e.g. long acting β2 agonist \[LABA\], long acting muscarinic antagonist \[LAMA\]) with or without an inhaled corticosteroid maintenance therapy for their COPD.
• •9. Patients on self-management plans agree to consult a healthcare professional prior to taking oral corticosteroids or antibiotics for treatment of a COPD exacerbation.
• •10. Provide written informed consent.
• •11. Be the owner of a mobile phone, and be able to, and agree to, respond to the required SMS (text) messages for the trial.
• •12. Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception. Acceptable birth control methods are tubal occlusion, intrauterine device (provided coils are copper-banded), levonorgestrel intrauterine system (eg, Mirena™), medroxyprogesterone injections (eg, Depo- Provera™), etonogestrel implants (eg, Implanon™, Norplan™), normal and low dose combined oral pills, norelgestromin / ethinylestradiol transdermal system, intravaginal device (eg, ethinylestradiol and etonogestrel ), desogestrel (eg, Cerazette™), total sexual abstinence and vasectomised sexual partner. Women should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled IFN-β-1a/matching placebo. In addition to the acceptable birth control method (except for the practice of total sexual abstinence), condom (in UK with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-β-1a/matching placebo to prevent pregnancy.
• •Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply:
• •* Women \<50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and if FSH levels are in the postmenopausal range.
• •* Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
• •13. Motivation (in the Investigator's opinion) to comply with protocol requirements and complete all study visits, including the ability to communicate well with the Investigator and be capable of understanding the nature of the research and its treatment (including its risks and potential benefits).
• •* patients will continue to be recruited using the inclusion criterion FEV1 ≥40%, until the change to FEV1 ≥30% has been approved by the DSMC.