PER-024-16已完成未知
A MULTICENTER, RANDOMIZED, 52-WEEK, DOUBLE-BLIND, PARALLELGROUP, ACTIVE CONTROLLED STUDY TO COMPARE THE EFFICACY AND SAFETY OF QVM149 WITH QMF149 IN PATIENTS WITH ASTHMA
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 26 人开始时间: 2016年9月15日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 26
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
- 性别
- All
入选标准
- •1. Male and female adult patient ≥ 18 years old and ≤ 75 years.
- •2. Written informed consent must be obtained before any studyrelated
- •assessment is performed.
- •3. Patients with a diagnosis of asthma, (GINA 2015 ≥ step 4) for a
- •period of at least 1 year prior to Visit 1 (Screening).
- •4. Patients who have used ICS/LABA combinations (Appendix
- •10) for asthma for at least 1 year and at stable medium or high
- •doses of ICS/LABA for at least 1 month prior to Visit 1. 5. Patients must be symptomatic at screening despite treatment
- •with mid or high stable doses of ICS/LABA. Patients with
- •ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (randomization
- •visit) (GINA 2015 step≥ 4).
- •6. Patients with documented history of at least one asthma
- •exacerbation which required medical care from a physician, ER
- •visit (or local equivalent structure) or hospitalization in the 12
- •months prior to Visit 1 and required systemic corticosteroid
- •Previous asthma exacerbation in this context is based on
- •patient´s recall of unplanned need for medical care at any
- •primary care physician, pulmonologist, emergency room and/or
- •hospital due to an aggravation of asthma symptoms requiring
- •treatment with systemic corticosteroids due to asthma
- •exacerbation. Every effort should be made by the site to
- •obtain/have appropriate source documentation for these
- •previous asthma exacerbations.
- •7. Pre-bronchodilator FEV1 of < 80 % of the predicted normal
- •value for the patient after withholding bronchodilators (Table 5-
- •2) at both visits 101 and 102.
- • Withholding period of bronchodilators prior to spirometry:
- •SABA for ≥ 6 hrs.
- •LABA (or fixed dose combination of ICS/LABA) for ≥ 24 hrs
- •(48 hrs for indacaterol fixed dose combination (FDC)), SAMA
- •for ≥ 8 hrs, xanthines ≥ 7 days.
- • Re-testing is allowed once only. Re-assessment of
- •percentage predicted FEV1 should be done in an ad-hoc
- •visit to be scheduled on a date that would provide sufficient
- •time to receive confirmation from the spirometry data
- •central reviewer of the validity of the assessment before
- •randomization.
- •Spacer devices are not permitted during reversibility testing.
排除标准
- • Patients who have had an asthma attack/exacerbation requiring
- •systemic steroids or hospitalization or emergency room visit
- •within 6 weeks of Visit 1 (Screening).
- • Patients who have ever required intubation for a severe asthma
- •attack/exacerbation
- • Patients who have a clinical condition which is likely to be
- •worsened by ICS administration (e.g. glaucoma, cataract and
- •fragility fractures) who are according to investigator´s medical
- •judgment at risk participating in the study)
- • Patients treated with a LAMA for asthma within 12 months
- •prior Visit 1 (Screening).
- • Patients with narrow-angle glaucoma, symptomatic benign
- •prostatic hyperplasia (BPH) or bladder-neck obstruction or
- •severe renal impairment or urinary retention. BPH patients who
- •are stable on treatment can be considered).
- • Patients who have had a respiratory tract infection or asthma
- •worsening according to the definition in Section 6.4.4 within 4
- •weeks prior to Visit 1 (Screening) or between Visit 1 and Visit
- •102. Patients may be re-screened 4 weeks after recovery from
- •their respiratory tract infection or asthma worsening
- • 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 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
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