EUCTR2015-000801-38-SK进行中（未招募）1 期
A two-arm, randomised, assessor-blind, parallel group study to evaluate the effect of fluticasone/formoterol breath actuated inhaler (BAI) and Relvar Ellipta DPI on ventilation heterogeneity in subjects with partially controlled or uncontrolled asthma. - KFL3502
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
- 90
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
- •Subjects to be included in the study are those who meet all of the following criteria:
- •Inclusion criteria (for subjects on Seretide Accuhaler 250/50 µg at screening):
- •1. Male and female subjects =18 years old.
- •2. Female subjects less than one year post-menopausal must have a negative urine
- •pregnancy test recorded at the screening visit prior to the first dose of study
- •medication, be non-lactating, and willing to use adequate and highly effective
- •methods of contraception throughout the study. A highly effective method of birth
- •control is defined as those which result in a low failure rate (i.e., less than
- •1% per year) when used consistently and correctly such as sterilisation,
- •implants, injectables, combined oral contraceptives, some IUDs (Intrauterine
- •Device, hormonal), true sexual abstinence, where this is in line with the
- •preferred and usual lifestyle of the participant, 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).
- •3. Documented clinical history of asthma for = 6 months prior to screening visit.
- •4. Using Seretide Accuhaler at a stable dose of 250/50 µg BID at screening for = 8
- •5. Uncontrolled asthma as defined by Asthma Control Questionnaire (ACQ-6) score =1.0.
- •6. R5-R20 = 0.08 kPa/L/s as measured on impulse oscillometry during the screening
- •7. Historical evidence (within past 24 months) of eosinophilic airways disease, evidenced by sputum eosinophil count = 3% and/or FeNO = 35 ppb or a blood eosinophil count =0.3 x 109/L at screening or in the past 12 months.
- •8. Good compliance with current asthma medication(s) in the Investigators opinion.
- •9. Willing and able to substitute pre-study prescribed inhaled asthma medication for
- •the entire duration of the study.
- •10. Willing and able to attend all study visits.
- •11. Written informed consent obtained.
- •Inclusion criteria (for subjects on equivalent /higher dose or other ICS-LABAs or higher dose of Seretide at screening):
- •1. Male and females subjects =18 years old.
- •2. Female subjects less than one year post-menopausal must have a negative urine
- •pregnancy test recorded at the screening visit prior to the first dose of study
- •medication, be non-lactating, and willing to use adequate and highly effective
- •methods of contraception throughout the study. A highly effective method of birth
- •control is defined as those which result in a low failure rate (i.e., less than
- •1% per year) when used consistently and correctly such as sterilisation,
- •implants, injectables, combined oral contraceptives, some IUDs (Intrauterine
- •Device, hormonal), true sexual abstinence where this is in line with the
- •preferred and usual lifestyle of the participant, 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).
- •3. Documented clinical history of asthma for = 6 months prior to screening visit.
- •4. R5-R20 = 0.07 kPa/L/s as measured on impulse oscillometry during the screening
- •5. Historical evidence (within past 24 months) of eosinophilic airways disease, evidenced by sputum eosinophil count = 3% and/or FeNO = 35 ppb or a blood eosinophil count =0.3 x 109/L at s
排除标准
- •Subjects to be excluded from the study are those who meet any of the following criteria:
- •1. Any severe chronic respiratory disease other than asthma.
- •2. Participant has a smoking history = 10 pack years” (i.e., at least 1 pack of 20
- •cigarettes /day for 10 years or 10 packs/day for 1 year, etc.).
- •3. Current smoking history within 12 months prior to the Screening Visit.
- •4. Near fatal or life-threatening (including intubation) asthma within the past year.
- •5. Known history of systemic (injectable or oral) corticosteroid medication within 1
- •month of Visit 1.
- •6. Evidence of a clinically unstable disease as determined by medical history or
- •physical examination that, in the investigator’s opinion, precludes entry into
- •the study. ‘Clinically unstable’ is defined as any disease that, in the opinion
- •of the Investigator, would put the participant at risk through study participation,
- •or which would affect the outcome of the study.
- •7. In the investigator’s opinion a clinically significant upper or lower respiratory
- •infection within 4 weeks prior to Visit 1.
- •8. Current evidence or known history of alcohol and/or substance abuse within 12
- •months prior to the Screening Visit.
- •9.Subject has taken ß-blocking agents, tricyclic antidepressants, monoamine oxidase
- •inhibitors, astemizole, quinidine type antiarrhythmics, or potent CYP 3A4
- •inhibitors such as ketoconazole within 1 week prior to Screening Visit.
- •10. Current use of bronchodilators / anti-inflammatory agents other than those
- •specified in the protocol.
- •11. Known or suspected sensitivity to study drug or excipients.
- •12. Participation in a clinical drug study within 30 days of the screening visit.
- •13. Current participation in a clinical study
- •Exclusion Criteria for subset of subjects undergoing OE-MRI
- •1. Contraindication for MRI scanning (as assessed by local MRI safety
- •questionnaire), which includes but is not limited to: presence of non-MRI
- •compatible artificial heart valves, hydrocephalus shunts, intracranial aneurysm
- •clips, joint replacements or metal implants, pacemakers or other cardiac rhythm
- •management devices, claustrophobia, history of metal in the eye, presence of
- •shrapnel from a war injury, callipers or braces, dentures, dental plates or
- •hearing aids that include metal and cannot be removed, history of epilepsy or
- •black-outs, ear implants, piercings that cannot be removed, intrauterine
- •contraceptive device or coil.
- •2. Inability to stay in the supine position for the duration of the scanning
- •3. Obesity (body weight >140 kg).
- •Randomisation Criteria required following Run-in
- •1. R5-R20 = 0.08 kPa/L/s
- •2. ACQ-6 score =1.0
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