EUCTR2016-000472-22-DE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 therapy.
- •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 15 o 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
- •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 as determined by the investigator 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
- •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.
- •Patients who use a long acting muscarinic antagonist (LAMA) within 3 months prior to Visit 1
研究者
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