EUCTR2016-000472-22-SK进行中（未招募）1 期
A multi-center, randomized, 12-week treatment, double blind study to assess the efficacy and safety of QMF149 (150/80 microgram) compared with MF Twisthaler® (200 microgram) in adult and adolescent patients with asthma - n/a
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
- 802
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
入选标准
- •- Patients with a documented diagnosis of asthma for a period of at least
- •3 months prior to Screening Visit
- •- Patients who have used low dose ICS , with or without controller (ie,
- •LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1
- •month prior to Screening Visit
- •-Adult patients who are symptomatic despite treatment with existing
- •Patients with ACQ-7 score = 1.5 at Visit 101 and at Visit 102
- •(inadequately
- •controlled).
- •- Adolescent patients : If taking only ICS (without LABA) and are
- •symptomatic at screening despite treatment with low doses of ICS.
- •These patients must have ACQ-7 score = 1.5 at Visit 101 and at Visit 102
- •. If taking ICS (low dose)/ LABA, and have ACQ-7 score =1 and <1.5 at
- •Visit 101: they must have ACQ-7 score=1.5 at Visit 102 ( prior to
- •randomization).
- •- Pre-bronchodilator FEV1= 60 % and < 90 % of the predicted normal
- •value for the patient after withholding bronchodilators at both Visits 101 and 102
- •- Patients who demonstrate an increase in FEV1 of 12% and = 200 mL
- •within 30 minutes after administration of 400 microgram
- •salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 665
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •- Patients who have smoked or inhaled tobacco products (including
- •electronic cigarettes) within the 6 month period prior to Visit 1, or who
- •have a smoking history of greater than or equal to 10 pack year.
- •- Patients who have had an asthma attack/exacerbation requiring
- •systemic steroids or hospitalization (> 24 hours) or emergency room
- •visit (= 24 hours) as follows:
- •For adults: within 6 weeks of Screening Visit. If patients experience an
- •asthma attack/exacerbation requiring systemic steroids or emergency
- •room visit between Visit 1 and Visit 102 they may be re-screened 6
- •weeks after recovery
- •from the exacerbation
- •For adolescents: Severe asthma attack/exacerbation requiring systemic
- •corticosteroid in the last 6 months or hospitalization (> 24 hours) due
- •to severe asthma attack/exacerbation requiring systemic corticosteroids
- •in the last 6 months or emergency room visit (=24 hours) due to severe
- •asthma attack/exacerbation requiring systemic corticosteroids within
- •the last 6 months..
- •- Patients who ever required intubation for a severe asthma
- •attack/exacerbation
- •- Patients with a clinical condition (eg. glaucoma, cataract and fragility
- •fractures) which may be worsened by ICS administration (according to
- •investigator's medical judgment )
- •- Patients who have had a respiratory tract infection or asthma
- •worsening within 4 weeks prior to Screening Visit or between Visit 1and
- •Visit 102. Patients may be re-screened 4 weeks after recovery from their
- •respiratory tract infection or
- •asthma worsening.
- •- Patients with any chronic conditions affecting the upper respiratory
- •tract (eg.chronic sinusitis) which in the opinion of the investigator may
- •interfere with the study.
- •- Patients with a history of chronic lung diseases other than asthma,
- •including (but not limited to) COPD, sarcoidosis, interstitial lung disease,
- •cystic fibrosis, clinically significant bronchiectasis and active
- •tuberculosis.
- •- Patients with Type I diabetes or uncontrolled Type II diabetes.
- •- Patients with narcolepsy and/or insomnia.
- •- Patients on Maintenance Immunotherapy (desensitization) for allergies
- •or less than 3 months prior to Visit 101 or patients on Maintenance
- •Immunotherapy for more than 3 months prior to Visit 101 but expected
- •to change throughout the course of the study.
- •- Patients with diagnosed rare hereditary problems of galactose
- •intolerance, the Lapp lactase deficiency or glucose-galactose
- •malabsorption or with known intolerance to lactose or milk products.
研究者
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