EUCTR2007-006545-41-GB进行中（未招募）1 期
A PHASE IIB STUDY TO INVESTIGATE THE TREATMENT-SPARING EFFECTS OF AEROVANT™ (AER 001 INHALATION POWDER) IN ASTHMA PATIENTS NOT FULLY CONTROLLED ON CURRENT THERAPY - AEROVANT
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 536
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
- •In order to be eligible for the study each of the following criteria must be satisfied with a YES” answer:
- •1) Male or female patient, =18 years of age with a documented clinical history of
- •asthma, has been treated for asthma and, in the opinion of the Investigator, is not
- •fully controlled on current asthma therapy.
- •2) Patient satisfies, or has satisfied in the past, the GINA definition of moderate
- •persistent to severe persistent asthma.
- •3) Patient has been maintained on moderate-to-high doses of ICS and LABA in the
- •form of combination therapy or as individual agents (equivalent to fluticasone
- •=250 mcg bid and salmeterol = 50 mcg bid for = 4 weeks before Screening
- •[Visit 1]).
- •4) Patient has experienced an asthma exacerbation at least once in the past 2 years
- •(defined here as use of physician prescribed oral corticosteroids or asthma
- •requiring treatment increase approximately 4 times the baseline dose of inhaled
- •corticosteroids or hospitalization due to asthma).
- •5) Patient has a pre-bronchodilator FEV1 = 50% but = 95% of the predicted value at
- •both Screening (Visit 1) and Visit 2.
- •6) Patient demonstrates = 12% reversibility (and a = 200 mL difference) from prebronchodilator FEV1 within 15 to 30 minutes of receiving up to 4 puffs of a short-acting beta-agonist at Screening (Visit 1). Alternatively, the patient has = 10% reversibility from pre-bronchodilator FEV1 plus a documented reversibility of = 12% (and a = 200 mL difference) or documented methacholine or histamine sensitivity (PC20) < 8mg/mL within the previous 12 months.
- •7) Patient scores = 20 on The Asthma Control Test™ at Screening (Visit 1) and
- •8) Female patient of childbearing potential or male patient and his female partner are practicing adequate and effective forms of contraception and agree to continue for the duration of the study (see Section 4.7.2). If female and of child-bearing potential, must have a negative urine pregnancy test.
- •9) Patient has a pre-study medical history, physical examination, 12-Lead ECG, and
- •safety laboratory test results within normal reference ranges or clinically
- •acceptable to the Investigator.
- •10) Patient is a non-smoker for at least 6 months before Screening (Visit 1) and has a < 10 pack-year history of smoking.
- •11) Patient is medically stable for at least 8 weeks before Randomization (Visit 2),
- •and the Investigator does not consider study participation to place the patient at
- •increased risk of AEs (with the exception of possible asthma exacerbations).
- •12) Patient is able and willing to give written 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •In order to be eligible for this study, each of the following criteria must be satisfied with a NO” answer:
- •1) Patient has a current diagnosis of respiratory disorder other than asthma (e.g.,
- •chronic bronchitis, bronchiectasis, emphysema, chronic obstructive pulmonary
- •disease [COPD], etc).
- •2) Patient has received oral corticosteroid treatment within 8 weeks of
- •Randomization (Visit 2) or patient has been intubated for ventilation in the past 5
- •3) Patient has used any leukotriene antagonist within 1 week before Screening
- •(Visit 1) or anti-IgE medications within 4 weeks of Screening (Visit 1).
- •4) Female patient is pregnant, breastfeeding, or not using an adequate method of
- •contraception as defined in Section 4.7.2 (of the protocol).
- •5) Patient has a clinically relevant history of very severe asthma or other medical
- •history that would preclude steroid reduction or sufficient compliance with the
- •6) Patient uses concomitant medications, including herbal, over-the-counter, or
- •prescription medicines that, in the opinion of the Investigator, may affect the
- •outcome of study endpoints and/or well-being of the patient.
- •7) Patient has a history of alcohol or substance abuse within 2 years of Screening
- •(Visit 1).
- •8) Patient consumes more than 28 units (male) or 21 units (female) of alcohol a week
- •(unit = 1 glass of wine = 1measure of spirits = ½ pint or 8 fluid ounces of beer).
- •9) Patient cannot communicate reliably with the Investigator or is unlikely to
- •cooperate with the requirements of the study.
- •10) Patient has previously taken AEROVANT™ or another formulation of AER 001
- •(e.g., BAY 16-9996, pitrakinra).
- •11. Patient has participated in any clinical trial involving use of an investigational drug within 12 weeks of first dose of AEROVANT™/placebo.
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