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A Study to Test a Potential New Treatment for COPD Patients Suffering From the Common Cold or Influenza
Bu çalışma, soğuk algınlığı veya grip (influenza) geçiren kronik obstrüktif akciğer hastalığı (COPD) olan hastalarda solunum yoluyla verilen Interferon Beta-1A ilacını plaseboyla karşılaştırarak olası yeni bir tedaviyi test ediyor. Katılım için 40-85 yaş arası, en az 12 aydır KOAH tanısı bulunan ve düzenli olarak uzun etkili bronkodilatör kullanan hastalar uygundur. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
PART 1 - 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).
PART 2 - pre-treatment Inclusion Criteria:
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.
PART 1 - Exclusion Criteria:
1. Any condition, including findings in the medical history or in the pre-randomisation assessments that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct or evaluation.
2. Current treatment or treatment within the past 6 weeks with oral corticosteroids.
3. Oxygen saturation of ≤ 92%.
4. Patients who require any form of oxygen therapy or non-invasive ventilation.
5. The patient has received live/attenuated vaccines in the past six weeks prior to randomisation or inactivated/killed, subunit or conjugate vaccines in the past two weeks prior to randomisation.
6. Current or previous participation in another clinical trial where the patient has received a dose of an investigational medicinal product (IMP) containing small molecules within 12 weeks prior to entry into this study or containing biologicals within 12 months prior to entry into this study.
7. Active interstitial lung disease or past history of lung cancer not considered cured, significant bronchiectasis, cystic fibrosis, alpha-1 antitrypsin deficiency or a history of significant chronic asthma.
8. Patients who currently have, or have had within the past 3 months, any significant underlying medical condition(s) that could impact the interpretation of results (e.g. non respiratory infections, haematological disease, malignancy, renal disease, hepatic disease, coronary heart disease or other cardiovascular disease \[including arrhythmias\], endocrine or gastrointestinal disease).
9. History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation.
10. Significant history of depressive disorder or suicidal ideation. Specifically, individuals with current severe depression (i.e. a low mood, which pervades all aspects of life and an inability to experience pleasure in activities that formerly were enjoyed); individuals with a past history of depression that required hospitalisation or referral to psychiatric services in the past 5 years; individuals who currently feel suicidal or have attempted suicide in the past.
11. Patients who are currently receiving anti-epileptic therapy and/or have uncontrolled epilepsy.
12. History of drug or alcohol abuse within 12 months prior to enrolment.
13. Female who is breast-feeding, pregnant or intends to become pregnant.
14. Patients with clinically significant arrhythmias or implantation of permanent pacemaker or implanted cardiac defibrillator.
15. Patients with unstable ischaemic heart disease (including, but not limited to, unstable angina or myocardial infarction) or stroke within the preceding 6 months.
PART 2 - Pre-treatment Exclusion Criteria:
1. Any condition, including findings in the medical history or in the pre-study assessments, or any treatment, that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct or evaluation.
2. The patient currently has a moderate or severe exacerbation of COPD.
3. The patient had a moderate or severe exacerbation of COPD that resolved less than 2 weeks ago (with resolution defined as return to patient's baseline COPD symptoms or the Investigator does not expect any further improvement of patient's symptoms).
4. The patient stopped taking treatment (antibiotics and/or oral corticosteroids) for an exacerbation of COPD less than 2 weeks ago.
5. The patient currently has an upper or lower respiratory tract infection.
6. Oxygen saturation of ≤92% .
7. Patients who require long-term oxygen therapy.
8. Current or previous participation in another clinical trial where the patient has received a dose of an IMP containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study.
9. Active interstitial lung disease or past history of lung cancer not considered cured, significant bronchiectasis, cystic fibrosis, alpha-1 antitrypsin deficiency or a history of significant chronic asthma.
10. Patients who currently have, or have had within the past 3 months, any significant underlying medical condition(s) that could impact interpretation of results (e.g. non respiratory infections, haematological disease, malignancy, renal disease, hepatic disease, coronary heart disease or other cardiovascular disease \[including arrhythmias\], endocrine or gastrointestinal disease).
11. History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation.
12. Significant history of depressive disorder or suicidal ideation. Specifically, individuals with current severe depression (i.e. a low mood, which pervades all aspects of life and an inability to experience pleasure in activities that formerly were enjoyed); individuals with a past history of depression that required hospitalisation or referral to psychiatric services in the past 5 years; individuals who currently feel suicidal or have attempted suicide in the past 5 years.
13. Patients who are currently receiving anti-epileptic therapy and/or have uncontrolled epilepsy.
14. History of drug or alcohol abuse within 12 months prior to enrolment .
15. Female who is breast-feeding, lactating, pregnant or intends to become pregnant.
16. Patients with clinically significant arrhythmias or implantation of permanent pacemaker or implanted cardiac defibrillator.
17. Patients with unstable ischaemic heart disease (including, but not limited to, unstable angina or myocardial infarction) or stroke within the preceding 6 months.