EUCTR2015-000395-97-Outside-EU/EEA进行中（未招募）不适用
A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and P. aeruginosa (AIR-CF4)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 157
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
- •1. Patients = 6 years of age.
- •2. Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
- •a. Sweat chloride = 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT);
- •b. Two well-characterized mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene; or
- •c. Abnormal nasal potential difference.
- •3. PA present in expectorated sputum or throat swab culture at Visit 1 OR documented PA in 2 expectorated sputum or throat swab cultures within the 12 months prior to Visit 1. (One of the previous PA positive cultures must be no more than 3 months prior to Visit 1.)
- •4. FEV1 > 75% predicted at Visit 1.
- •5. Patient must exhibit two or more of the following chronic and/or intermittent CF symptoms, for a minimum of 28 days prior to randomization and with no worsening of symptoms within 7 days prior to randomization:
- •a. Chest congestion
- •b. Daily cough
- •c. Productive cough
- •d. Wheezing
- •e. Trouble breathing
- •f. Nocturnal wakening due to coughing
- •6. Patients (and parent/guardian as required) must be able to provide written informed consent/assent prior to any study related procedures.
- •7. Females of childbearing potential must have a negative urine pregnancy test at Visit 1.
- •8. Ability to perform reproducible pulmonary function tests.
- •9. In the opinion of the Investigator, the patient does not require immediate antipseudomonal antibiotic intervention to treat an impending exacerbation, and the patient’s condition is stable enough to enroll in the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 89
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 68
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Administration of any investigational drug or device within 28 days prior to Visit 1 or within 6 half-lives of the investigational drug (whichever is longer).
- •2. Administration of any IV, oral, or inhaled antipseudomonal antibiotic within 28 days prior to Visit 1.
- •3. Known local or systemic hypersensitivity to monobactam antibiotics.
- •4. Inability to tolerate short-acting bronchodilator use at least three times daily.
- •5. Changes in or initiation of chronic azithromycin treatment within 28 days prior to Visit 1.
- •6. Changes in or initiation of chronic hypertonic saline treatment within 28 days prior to Visit 1.
- •7. Changes in or initiation of dornase alpha within 28 days prior to Visit 1.
- •8. Changes in antimicrobial, bronchodilator (BD), or corticosteroid medications within 7 days prior to Visit 1.
- •9. Changes in physiotherapy technique or schedule within 7 days prior to Visit 1.
- •10. History of lung transplantation.
- •11. History of participation (enrollment) in any prior clinical trials with AZLI.
- •12. A chest radiograph at Visit 1 (or within the previous 180 days of Visit 1), with abnormalities indicating a significant acute finding (e.g., lobar infiltrate and atelectasis, pneumothorax, or pleural effusion). A chest radiograph obtained and interpreted between Visits 1 and 2 is also acceptable for determining eligibility.
- •13. Positive urine pregnancy test at Visit 1; all women of childbearing potential will be tested.
- •14. Females of childbearing potential who are lactating or are not (in the opinion of the investigator) practicing an acceptable method of birth control; female patients who utilize hormonal contraceptives as their birth control method must have used the same method
- •for at least 3 months before study dosing.
- •15. Patient is being assessed at Visit 1 by the investigator for an acute change in respiratory symptoms.
- •16. Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment, or compliance with the protocol.
研究者
相似试验
进行中（未招募）
不适用
A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2 g per day of strontium ranelate versus alendronate 70 mg per week in women with postmenopausal osteoporosis on bone geometry and bone strength measured by peripheral-Quantitative Computed Tomography (p-QCT). - NDMedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausalpostmenopausal osteoporosisEUCTR2007-001509-11-ITINSTITUT DE RECHERCHES INTERNATIONALES SERVIER80
进行中（未招募）
不适用
A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2 g per day of strontium ranelate versus alendronate 70 mg per week in women with postmenopausal osteoporosis on bone geometry and bone strength measured by peripheral-Quantitative Computed Tomography (p-QCT).EUCTR2007-001509-11-SEInstitut de Recherches Internationales Servier148
进行中（未招募）
不适用
A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2 g per day of strontium ranelate versus alendronate 70 mg per week in women with postmenopausal osteoporosis on bone geometry and bone strength measured by peripheral-Quantitative Computed Tomography (p-QCT). - STRATECPost-menopausal osteoporosisMedDRA version: 9.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalEUCTR2007-001509-11-GRInstitut de Recherches Internationales Servier80
进行中（未招募）
不适用
A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2 g per day of strontium ranelate versus alendronate 70 mg per week in women with postmenopausal osteoporosis on bone geometry and bone strength measured by peripheral-Quantitative Computed Tomography (p-QCT). - STRATECEUCTR2007-001509-11-DEInstitut de Recherches Internationales Servier80
进行中（未招募）
不适用
A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2g per day of strontium ranelate versus alendronate 70mg per week in women with postmenopausal osteoporosis on bone microarchitecture measured by high resolution peripheral-Quantitative Computed Tomography (p-QCT).EUCTR2006-002732-22-DEInstitut de Recherches Internationales Servier72