CTRI/2008/091/000302已完成3 期
Efficacy and safety evaluation of a dry powder inhaler containing Salmeterol 25 mcg /Fluticasone Propionate 250 mcg in subjects with asthma: A randomized, open label, comparative, active controlled, parallel groups, and multi-centric study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 113
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
入选标准
- •Men and women age 18-60 years inclusive.
- •Women of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or log acting injected contraceptives] for atleast 2 months prior to study entry. Or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject), with a negative urine pregnancy test.
- •BMI within 18.5 â?? 30.0 kg/m2 inclusive.
- •Received pharmacotherapy for asthma for the preceding 6 months: either inhaled corticosteroids for the last 3 months preceding screening or inhaled long-acting β2 agonists for at least 1 week prior to screening, or on combination of both the drugs with a washout of 2 weeks prior to taking study medication.
- •Reversible bronchial obstruction (Bronchial obstruction is defined as reversible when inhalation of 200 mcg (two actuations of 100 mcg) of salbutamol from a MDI causes the FEV1 value to increase by at least 12% or 200 ml within 15 minutes)
- •Screening visit FEV1 is 40- 80% of the predicted normal value
- •Withholding the following medication for the specified time prior to screening and for the duration of the study:
- •Oral corticosteroids•1 month
- •Parenteral corticosteroids•1 month
- •Inhaled anticholinergics•24 hours
- •Inhaled cromolyn or nedocromil sodium•1 month
- •Oral short-acting β2 agonists•12 hours
- •Oral long-acting β2 agonists•24 hours
- •Inhaled long-acting β2 agonists•24 hours
- •Anti-histamines like Cetirizine, Terfenadine, Fexofenadine,
- •Hydroxyzine, Ebastine, Azatadine•72 hours
- •Oral and Parenteral Macrolide antibiotics•30 days
- •Subject Inclusion Criteria at Visit 2
- •o8.1 For subjects who were using inhaled corticosteroids at screening; not more than 12 puffs per day of salbutamol for more than 3 days of their last 7 days during 2-week run-in.
- •oFor subjects who were using inhaled long-acting β2 agonists at screening; not more than 6 puffs per day of salbutamol for more than 3 days of their last 7 days during 2-week run-in.
- •oSubjects who awakened due to asthma; not more than 3 days of last 7 nights during 2-week run-in.
- •oFEV1 is within +15% of the screening visit value and within 40- 80% of the predicted normal at Visit 2 (randomization).
排除标准
- •*History or presence of significant:
- •Allergy or Significant history of hypersensitivity or idiosyncratic reactions to fluticasone and salmeterol or any related compounds etc.; Severe exacerbation of asthma that required hospitalization in last 2 months; Occupational asthma; Change of asthma medication during the preceding 4 weeks; Associated COPD; Active respiratory tract infection; Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year; Clinically significant illness within 4 weeks before the start of the study; Clinically significant abnormal ECG or chest x-ray; Inability to use DPI device correctly.*Current smokers or subjects with a ≥ 10 pack year history.*Participation in another clinical trial within the preceding 90 days of study starts.*Currently taking β-blockers, oral decongestants, benzodiazepines, digitalis, phenothiazines, antidepressants, MAO inhibitors.*Use of medications like ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin that significantly interact with cortcosteroids metabolism within 6 weeks of enrollment.
研究者
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