EUCTR2012-003395-40-DE进行中（未招募）不适用
Double-blind, masked, randomized, three period crossover study to evaluate the changes in exhaled nitric oxide (eNO) following treatment with fluticasone propionate MDI Aerosol in patients with chronic mild to moderate persistent asthma.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Male or female subjects must be 18 to 65 years (inclusive) of age at screening visit.
- •2. BMI between 18 and 35.
- •3. Willingness to give written informed consent and ability to adhere to dose and visit schedules.
- •4. Fractional exhaled nitric oxide (FeNO) = 45 ppb at screening visit.
- •5. Forced expiratory volume in one second (FEV1) = 60% predicted (NHANES III) at screening and baseline visits.
- •6. No tobacco within 6 months and does not have history of smoking > 10 pack years.
- •7. = 6 months of chronic, persistent asthma (NAEPP 3). To document asthma diagnosis, historical reversibility defined as an increase in absolute forced expiratory volume (in liters) in 1 second (FEV1) of = 12 % and = 200 mL must have been performed within 12 months prior to screening visit. For subjects without historical reversibility, one of the following methods can be used at the screening visit or at any time before the baseline visit (for definition see below):
- •7a. Demonstration of an increase in absolute FEV1 of at least 12 % and a volume increase of at least 200 mL within 15-40 minutes after administration of 4 inhalations of salbutamol (total dose 360 to 400 mcg) or of nebulized short-acting beta-agonist (SABA) (2.5 mg), if confirmed as standard office practice, OR
- •7b. Demonstration of a peak expiratory flow (PEF) variability of more than 20 % expressed as a percentage of the mean highest and lowest morning pre-bronchodilator PEF over at least 1 week, OR
- •7c. Demonstration of a diurnal variation PEF of more than 20 % based on the difference between the pre-bronchodilator (before taking salbutamol) morning value and the post-bronchodilator value (after taking salbutamol) from the evening before, expressed as a percentage of the mean daily PEF value on any day during the open-label Run-in Period.
- •8. Clinical laboratory tests (complete blood count, blood chemistries, and urinalysis) conducted at the screening visit must be within normal limits or clinically acceptable to the investigator.
- •9. An electrocardiogram (ECG) performed at the screening visit or within 30 days prior to screening visit must be clinically acceptable to the investigator and have a QTc interval < 450 milliseconds (msec).
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Use of systemic glucocorticosteroids within 3 months before screening visit.
- •2. Upper or lower respiratory tract infection within 6 weeks before screening visit.
- •3. Decrease in absolute forced expiratory volume in one second (FEV1) > 20 % between screening visit and baseline visits.
- •4. Requirement for > 8 inhalations per day of short-acting beta-agonist (SABA) metered dose inhaler, or 2 or more nebulized treatments of 2.5 mg SABA, on any 2 consecutive days between the screening visit and baseline visits.
- •5. A clinical asthma exacerbation defined as a clinical deterioration of asthma that results in emergency treatment, hospitalization for asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids but allowing SABA), as per investigator, between screening visit and baseline visits.
- •6.Clinically significant concomitant disease which may have an impact on the study participation.
- •7. Hyper-sensibility against fluticasone or study drug components.
- •8. Patients who have had treatment with live attenuated vaccinations within 14 days prior to screening visit (inactivated influenza vaccination is acceptable, provided that it is not administered within 7 days prior to screening visit).
- •9. The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) within 6 weeks prior to screening.
- •10. The use of nitric oxide synthase inhibitors, leukotriene-axis modifiers (zileuton, zafirlukast, montelukast), nitric oxide donor drugs (nicorandil, furoxan) and L-arginine.
- •11. Other respiratory diseases (e.g. chronic obstructive pulmonary disease (COPD), cystic fibrosis, alpha-1-antitrypsin deficiency, sarcoidosis, bronchiectasis, allergic alveolitis, tuberculosis, etc.).
- •12. Other fungal, bacterial, viral or parasitic infections or ocular herpes simplex or chickenpox.
- •13. Drug or alcohol abuse which would interfere with the subject’s compliance.
- •14. For female subjects only: Has a positive urine pregnancy test at screening visit, is lactating, or is not practicing a medically acceptable form of contraception or abstinence. If abstinent, the subject must agree to use a double-barrier-method if she becomes sexually active during the study, If surgically sterilized (including hysterectomy) or postmenopausal, no contraceptive method is necessary.
- •15. Has participated in another study with an investigational drug within 1 month prior to screening visit. Observational studies are allowed if permission has been obtained from the sponsor.
- •16. Employee at study site, or spouse/partner or relative of the investigator or sub-investigator.
研究者
相似试验
Unknown
不适用
Clinical study of turmeric extract formulations on 18 healthy human subjects.CTRI/2017/03/008069Arjuna Natural Extracts Ltd
已完成
不适用
A double-blind, randomized, controlled, 3-way crossover, pilot study to evaluate the duration of effects on simulated car driving and cognitive performance after a single dose of JNJ-42847922, zolpidem and placebo in healthy subjects10040991InsomniaDepressionNL-OMON42615Janssen-Cilag36
进行中（未招募）
不适用
A double-blinded, randomised, three-period crossover euglycaemic clamp trial investigating the pharmacokinetics, glucodynamics and safety of BC222 human insulin, human insulin (Huminsulin® Normal) and insulin lispro (Humalog®) in subjects with type 1 diabetesDiabetes mellitus type 1MedDRA version: 17.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2014-001432-11-DEAdocia
已完成
1 期
A clinical trial to compare the pharmacokinetic and pharmacodynamic profile of two preparations of pegfilgrastimACTRN12612000920897Dr. Reddy’s Laboratories (DRL)36
进行中（未招募）
1 期
A randomised, double-blind, double dummy, 3 way cross-over study evaluating the effects of Seretide 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg alone and Seretide 50/500mcg alone) in the treatment of subjects with COPDCOPDEUCTR2005-004434-40-GBGlaxoSmithKline Research and Development Ltd