EUCTR2015-002046-31-PL进行中（未招募）1 期
A randomised, single blind, cross-over study to compare a fixed dose combination of fluticasone propionate / formoterol fumarate (fluticasone /formoterol breath actuated inhaler (BAI)) with a fixed dose combination of indacaterol maleate / glycopyrronium bromide (Ultibro® Breezhaler) in subjects with fixed airflow obstruction and elevated eosinophils.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female subjects aged = 40 years at Screening visit.
- •2. Adequate contraception:
- •- Female subjects of child bearing potential (less than 1 year post-menopausal) must have a negative urine pregnancy test prior to first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of birth control throughout the study such as sterilisation, implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence, where this is line with the preferred and usual lifestyle of the subject or vasectomised partner.
- •Note: Periodic abstinence (calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for duration of study, and withdrawal are not acceptable methods of contraception).
- •- Male subjects with a partner of child-bearing potential must be willing to use adequate and highly effective methods of birth control throughout the study (as defined above).
- •3. Diagnosis of fixed airflow obstruction with elevated eosinophils /ACOS as evidenced by:
- •- Chronic respiratory symptoms e.g. wheezing, dyspnoea, especially exertional dyspnoea) for at least 6 months prior to Screening.
- •- Smoking history of = 10 pack years (equivalent to, for example, 20 cigarettes/day for 10 years or 10 cigarettes/day for 20 years).
- •- Post-bronchodilator FEV1 / FVC ratio < 0.7 and post bronchodilator FEV1 >30 and <=60% predicted normal measured at visit 1 (GLI 2012).
- •- Evidence of eosinophilic inflammation demonstrated by eosinophils in induced sputum of =3% at Visit 1 (assessed at central laboratory) and Visit 3 (assessed at local laboratory).
- •4. Subjects symptomatic at Visit 1 (CAT =10) despite currently receiving treatment with either LAMA or LABA monotherapy or LAMA + LABA as a combination inhaler or separate inhalers.
- •5. Documented history of = 1 moderate or severe respiratory disease exacerbations (requiring treatment with systemic corticosteroids and/or antibiotics and/or hospitalisation) in the previous year.
- •6. Willing and able to replace current therapy for obstructive lung disease with study medication.
- •7. Able to demonstrate correct use of a BAI, Breezehaler and pMDI.
- •8. Willing and able to attend all study visits and complete study assessments.
- •9. Able to provide signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1. Respiratory disease exacerbation between 4 weeks prior to screening and Visit 3 (Randomisation).
- •2. Previous treatment with ICS.
- •3. Documented evidence of a1-antitrypsin deficiency.
- •4. Other active respiratory disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans.
- •5. Use of long-term oxygen therapy (LTOT) at least 12 hours daily or mechanical ventilation.
- •6. Chest X-ray or CT scans performed prior to screening which reveal evidence of clinically significant abnormalities reflective of active disease not believed to be due to COPD.
- •7. Evidence of uncontrolled cardiovascular disease.
- •8. Evidence of clinically significant renal, hepatic, gastrointestinal, or psychiatric disease.
- •9. Current malignancy or a previous history of cancer which has been in remission for < 5 years (basal cell or squamous cell carcinoma of the skin which has been resected is not excluded).
- •10. Clinically significant sleep apnoea requiring use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
- •11. Participation in the acute phase of a pulmonary rehabilitation programme within 4 weeks prior to screening or during the study.
- •12. Known or suspected history of drug or alcohol abuse in the last 2 years.
- •13. Requiring treatment with any of the prohibited concomitant medications.
- •14. Known or suspected hypersensitivity or contraindication to any of the study drugs or excipients.
- •15. Received an investigational drug within 30 days of the Screening.
- •16. Received a systemic corticosteroid within 30 days of the Screening visit.
研究者
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