CTRI/2023/05/052755已完成4 期
Phase IV, 12-week, single arm, open label study evaluating the safety and efficacy of fixed dose triple combination FF/UMEC/VI administered once daily in the morning via a dry powder inhaler in participants with chronic obstructive pulmonary disease in India.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- GSK
- 入组人数
- 229
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participants eligible for enrolment in the study must meet all of the following criteria:
- •1. Informed Consent: A signed and dated written informed consent prior to study
- •participation.
- •2. Type of participant: Outpatient.
- •3. Age: Participants 40 years of age or older at Screening (Visit 1).
- •4. Gender: Male or female participants.
- •Female participants:
- •A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •Not a woman of childbearing potential (WOCBP)
- •A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and until the safety follow-up contact after the last dose of study intervention.
- •5. COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004].
- •6. Smoking History: Current or former cigarette smokers with a history of cigarette smoking of more than or equal to 10 pack-years at Screening (Visit 1) (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those
- •who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or
- •cigar use cannot be used to calculate pack-year history.
- •7. Patient with history of =2 moderate exacerbations or one severe (hospitalized)
- •exacerbation in the previous 12 months, and with a score of =10 on the CAT eligible
- •for the study treatment in the opinion of the investigator and documented post
- •salbutamol FEV1/FVC ratio of <0.70
- •8. Existing COPD maintenance treatment: Participant must be receiving daily long acting maintenance treatment for their COPD for at least 3 months prior to Screening.
- •To be eligible for the study treatment phase, participants must be compliant with their
- •existing COPD maintenance therapy (in the opinion of the investigator) for the preceding two weeks prior to screening.
- •Note: Participants receiving only short-acting COPD medications are not eligible.
- •9. A negative test for active COVID-19 at Visit 1. The test should be done using a molecular (PCR or antigen test) approved by the country regulatory authorities.
排除标准
- •Participants meeting any of the following criteria must not be enrolled in the study:
- •1. Pregnancy: Women who are pregnant or lactating or are planning on becoming
- •pregnant during the study.
- •2. Asthma: Participants with a current diagnosis of asthma. (Participants with a prior
- •history of asthma are eligible if they have a current diagnosis of COPD).
- •3. Reversibility: Documented (medical records) evidence of reversibility.
- •Reversibility is defined as an increase in FEV1 of = 12% and =200mL following
- •administration of salbutamol. Participants defined as non-reversible will have a post-salbutamol increase in FEV1 of <200mL or a =200mL increase that is <12% from pre-salbutamol baseline.
- •4. a1-antitrypsin deficiency: Participants with a1-antitrypsin deficiency as the underlying cause of COPD.
- •5. Other respiratory disorders: Participants with active tuberculosis, lung cancer, and
- •clinically significant (in the opinion of the investigator): bronchiectasis, sarcoidosis,
- •lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active
- •pulmonary diseases.
- •6. Lung resection: Participants with lung volume reduction surgery within the 12
- •months prior to Screening.
- •7. Risk Factors for Pneumonia: immune suppression (e.g. advanced HIV with high viral load and low CD4 count, Lupus on immuno suppressants that would increase risk of pneumonia) or other risk factors for pneumonia (e.g. neurological disorders
- •affecting control of the upper airway, such as Parkinson’s Disease, MyastheniaGravis).
- •Patients at potentially high risk for pneumonia (e.g. very low BMI, severely malnourished, or very low FEV1) will only be included at the discretion of the investigator.
- •8. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved
- •at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any participant that experiences pneumonia and/or moderate or severe COPD exacerbation during the
- •run-in period will be excluded.
- •9. Respiratory tract infection that has not resolved at least 7 days prior to Screening.
- •10. Participants with known COVID-19 positive contacts within the past 14 days should
- •be excluded for at least 14 days since the exposure and the subject remains symptom
- •Participants with symptoms suggestive of active COVID-19 infection e.g. fever,
- •cough (new or worsened), etc are also excluded
- •11. Abnormal Chest x-ray: Chest x-ray (posteroanterior and lateral) reveals evidence of
- •pneumonia or a clinically significant abnormality not believed to be due to the
- •presence of COPD, or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. significant cardiomegaly, pleural effusion or scarring). All participants will have a chest x-ray at Screening Visit 1 (or historical radiograph or CT scan obtained within 3 months prior to screening).
- •12. Other diseases/abnormalities: Participants with historical or current evidence of
- •clinically significant cardiovascular, neurological, psychiatric, renal, hepatic,
- •immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin,
- •sensory, endocrine (including uncontrolled diabetes or thyroid disease) or
- •haematological abnormal
研究者
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