ISRCTN65297911已完成3 期
A double-blind Phase III evaluation of doxofylline, theophylline, and placebo in patients with chronic reversible asthma
Roberts Pharmaceutical Corporation0 个研究点目标入组 200 人开始时间: 2018年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
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. Males and nonpregnant females. Women of childbearing potential had to use acceptable methods of birth control and have a negative prestudy serum ß-hCG pregnancy test. Acceptable methods of birth control were limited to vaginal or intrauterine contraceptive devices or agents and natural (postmenopausal) or surgical sterility. Abstention, oral contraceptives, and use of contraceptive by the woman’s partner were not acceptable methods of birth control
- •2. Age: adults, 16 years of age or older
- •3. Health status: nonsmokers for at least 6 months before entering the study, in good physical condition with a more than 1-year history of chronic, extrinsic reversible hyperreactive airway disease (asthma)
- •4. Willing to undergo the procedures required in the protocol
- •5. Willing to undergo a chest x-ray if required by the Principal Investigator
- •6. On screening, subjects must have had a baseline FEV1 value within 50% to 80% of the predicted FEV1 value for their age and height, when immediate-release theophylline or sustained-release theophylline had been withheld for at least 24 hours. Subjects were further required to have abstained from use of any sympathomimetic, including beta-agonist inhalers, for at least 8 hours before the screening pulmonary function tests (PFTs)
- •7. On screening, subjects had to show at least a 15% increase in FEV1 30 minutes after administration of a standard dose (2 puffs, 180 µg) of albuterol
- •8. Subjects must have demonstrated, by verbal history, a period of at least 1 month of acceptable clinical control of their asthma in the preceding 3 years using oral theophylline, alone or in combination with a beta-agonist inhaler
- •9. Subjects had to weight at least 48 kg (105 lb)
排除标准
- •1. Clinically significant deviation from normal in physical examination, laboratory parameters, ECG, or chest x-ray, as evaluated by the Principal Investigator, that would have precluded the subject’s participation in the study
- •2. Clinically significant coexisting disease, including:
- •2.1. Clinically significant cardiovascular disease, including a history of congestive heart failure
- •2.2. Angina pectoris within 1 year
- •2.3. History of myocardial infarction within 1 year
- •2.4. Convulsive disorder
- •2.5. Clinically significant gastrointestinal disease, including active peptic ulcers within the preceding 5 years
- •2.6. Renal disease
- •2.7. Hepatic disease
- •2.8. Hematologic disease
- •2.9. Insulin-dependent diabetes mellitus
- •2.10. Nonreversible chronic pulmonary disease
- •2.11. Known infection with human immunodeficiency virus
- •2.12. Chronic obstructive pulmonary disease
- •3. Presence of any acute illness
- •4. Sensitivity to theophylline or theophylline-like agents
- •5. A resting heart rate of less than 50 bpm or greater than 100 bpm and/or an arterial blood pressure of less than 100/60 mmHg or greater than 140/90 mmHg when sitting
- •6. History of alcohol, narcotic, barbiturate, marijuana, or polydrug abuse
- •7. Participation in other investigational drug studies within 30 days before the start of this study
- •8. Subjects who were unlikely to be compliant with the protocol requirements
- •9. Oral contraceptive use was not allowed because of the propensity for these drugs to decrease theophylline clearance. If a woman became pregnant during the study, she was to be withdrawn from the study
- •10. Nursing mothers
- •11. Subjects using aerosol steroids were required to discontinue their use at least 1 month before the study and to refrain from using them throughout the entire study. Subjects using oral steroids to control bronchoconstriction were excluded from participation. Subjects using cromolyn sodium or oral steroids were required to discontinue their use at least 1 month before the study and to refrain from using them throughout the entire study, with the exception of acute steroid burst treatment
- •12. Due to their effects on theophylline clearance, none of the following could be taken during the study: allopurinol, ciprofloxacin, erythromycin, troleandomycin, lithium carbonate, phenytoin, rifampin, or cimetidine
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