EUCTR2011-005108-14-PL进行中（未招募）不适用
A single- dose, open label, randomized, 3-way crossover, clinical pharmacology study of CHF 1535 100/6 pMDI (fixed combination of beclomethazone dipropionate 100 µg plus formoterol fumarate 6 µg) with or without spacer device versus the free combination of licensed beclomethasone pMDI and formoterol pMDI in asthmatic adolescent patients and one open arm for adult patients as control group treated with CHF 1535 100/6 pMDI.
适应症
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 and female adolescents, aged = 12 and < 18 years or male and female adults, aged = 18
- •and = 65 years.
- •2. Written informed consent obtained by the patient in case of adult patients and by parents/legal
- •representative and by the minor (according to local regulation).
- •3. A diagnosis of asthma as defined in the GINA guidelines (updated 2010) 6 months before the
- •screening visit.
- •4. Male/female adolescent and adult patients with asthma stable enough, according to GINA
- •guidelines (updated 2010) and based on the Investigator’s opinion, to allow a wash out period
- •from inhaled BDP of 2 days before study each single day study treatments and any ICS other
- •than BDP of 1 day before each single day study treatments.
- •5. Male/female adolescents and adults asthmatic patients already treated with ICS or ICS/longacting
- •inhaled ß2-agonists or using short-acting inhaled ß2-agonists as reliever to control
- •asthma symptoms.
- •6. Adolescents and adults with a forced expiratory volume in one second (FEV1) > 70% of
- •predicted values (% pred) after withholding short acting ß2-agonist treatment for a minimum of
- •6 h prior to screening or 24 hours in case of long acting ß2-agonist.
- •7. Non- or ex-smokers who smoked less than 5 pack-years (e.g. < 20 cigarettes per day for 5 years)
- •and stopped smoking for at least 1 year.
- •8. A cooperative attitude and ability to be trained about the proper use of pMDI with and without
- •a spacer device and compliant to study procedures.
- •9. Body mass index (BMI) =18.5 and = 32 kg/m2
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant or breast-feeding female patients. Sexually active female not using efficient
- •contraception throughout the entire study period (e.g. oestro-progestatives, condoms,
- •intrauterine devices). A urinary pregnancy test will be performed at screening and treatment
- •visits (mandatory in the adult population and at discretion of the investigator in the adolescent
- •population) in women of childbearing potential;
- •2. Having received an investigational drug within 2 months before the screening visit (Visit 1)
- •3. Diagnosis of COPD, in the adult patients, as defined by the current GOLD guidelines (updated
- •4. Known hypersensitivity to the active treatments.
- •5. Inability to perform the required breathing technique and blood sampling.
- •6. Hospitalization due to exacerbation of asthma within 1 month prior to screening visit.
- •7. Lower respiratory tract infection within 1 month prior to screening visit;
- •8. Obesity, i.e. > 97% weight percentile by local standards.
- •9. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic,
- •endocrine diseases, that may interfere with patient’s safety, compliance, or study evaluations,
- •according to the Investigator’s opinion;
- •10. History of drug addiction or excessive use of alcohol (weekly intake in excess of 28 units
- •alcohol; one unit being a glass of beer, wine or a measure of spirits), or excessive consumption
- •of xanthine containing substances (daily intake in excess of 5 cups of coffee, tea, cola, etc) or
- •psychological or other emotional problems likely to invalidate informed consent, or limit the
- •ability of the subject to comply with the protocol requirements;
- •11. Treatment with a xanthine derivative (e.g. theophylline) formulations in the 4 weeks prior to
- •screening visit;
- •12. Blood donation (450 mL or more) (for the adult population) or significant blood loss in the 12
- •weeks before the screening visit.
研究者
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