CTRI/2020/09/027623已完成未知
A randomized, open-label, two-way crossover study to compare inhalation flow profiles generated with medication-free generic tiotropium bromide inhalation device of Cipla Ltd. India and SPIRIVA HANDIHALER device of Boehringer Ingelheim Pharmaceuticals, Inc., USA in healthy adult subjects and adult subjects with moderate, severe and very severe chronic obstructive pulmonary disease.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 104
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
- •1. Male and female healthy adult subjects of any ethnic origin, aged 18 to 55 years (inclusive).
- •2. Subjects willing to provide signed and dated written informed consent voluntarily.
- •3. Subjects having ability to read and understand.
- •4. Based on investigatorâ??s decision, subjects who can inhale as deep and fast as they can through an In-checkTM dial.
- •Forced vital capacity (FVC) >80%, Peak Expiratory Flow Rate (PEFR) >80%, Forced expiratory volume in one second (FEV1) >80% of that predicted by the ECSC formulae (confirmed by spirometry test), a FVC >80% and a FEV1/FVC ratio >= 0.75.
- •Note: For calculation of predicted values, other equations used in Caucasians can be used interchangeably with ECSC formula
- •6. Oxygen saturation >= 95%
- •7. No history of chronic airway disease, no current evidence of upper or lower respiratory tract infection.
- •8. Female subjects of childbearing potential must use an adequate method of contraception (e.g., hormonal birth control, intrauterine device, barrier method plus a spermicidal agent) during the study.
- •Subjects who are non-smokers or those who are ex-smokers and have less than a 10 pack-year history of smoking and have not consumed tobacco or tobacco containing products for at least 12 months prior to screening and who agree to abstain from the same during the study.
- •Adult subjects with COPD
- •1. Male and female subjects of any ethnic origin, aged 40 to <= 80 years
- •2. Subjects willing to provide signed and dated written informed consent voluntarily.
- •3. Subjects on stable symptoms of COPD since a month based on investigatorâ??s decision.
- •4. Based on investigatorâ??s decision, subjects who can inhale as deep and fast as they can through an In-checkTM dial.
- •Established diagnosis of COPD according to: The Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 for at least 3 months prior to Screening and who meet the following criteria:
- •- Post-bronchodilator FEV1/ Forced vital capacity (FVC) ratio of <70 %
- •- Post-bronchodilator FEV1 (within 15-30 minutes following intake of 400 mcg salbutamol) within the following range: 50% <= FEV1 < 80% of the predicted value for age, height and sex using the formula of the ECSC using appropriate correction factors for race
- •- Post-bronchodilator FEV1 (within 15-30 minutes following intake of 400 mcg salbutamol) within the following range: 30% <= FEV1 < 50% of the predicted value for age, height and sex using the formula of the ECSC using appropriate correction factors for race
- •Very severe
- •- Post-bronchodilator FEV1 (within 15-30 minutes following intake of 400 mcg salbutamol) within the following range: FEV1 < 30% of the predicted value for age, height and sex using the formula of the ECSC using appropriate correction factors for race.
- •6. Female subjects of childbearing potential must use an adequate method of contraception (e.g., hormonal birth control, intrauterine device, barrier method plus a spermicidal agent) during the entire study
- •VERSION 1.0, 02/01/2020 CONFIDENTIAL Page 30 of 64
- •7. The smokers or ex-smokers having history of >= 10 pack years prior to screening
排除标准
- •Subjects meeting any of the following exclusion criteria must not be enrolled into the study:
- •1. Acute exacerbation of COPD or hospitalization/emergency room visits due to COPD exacerbation within the last 2 months prior to study participation.
- •2. Requirement for oral/injectable steroid therapy due to unstable disease within the last 2 months prior to screening.
- •3. Significant lung/airway diseases other than the COPD diagnosis.
- •4. Surgery of the respiratory tract/lung or significant deformity (e.g., lung, conducting airways, thorax or vertebral column deformities) that may cause persistent airflow limitation or altered lung volumes.
- •5. Salbutamol intolerance or contraindication to salbutamol (for adult subjects with COPD).
- •6. Significant acute respiratory infections within the last 4 weeks or chronic viral, bacterial or fungal airway infections.
- •7. Other chronic or clinically relevant acute infections.
- •8 Neurological diseases affecting the neuro-muscular function or performance of respiratory muscles, e.g., such as Myasthenia Gravis or Amyotrophic Lateral Sclerosis.
- •9. Any major chronic illness including but not limited to a diagnosis of non-skin cancer, cystic fibrosis, bronchiectasis, α-1 anti-trypsin deficiency, myelomeningocele, sickle cell anemia, endocrine disease, congenital heart disease, unstable arrhythmia, congestive heart failure, stroke, severe hypertension, uncontrolled insulin-dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, significant neurodevelopmental delay or behavioral disorders (excluding mild attention deficit hyperactivity disorder.
- •10. History of diaphragm dysfunctions, diaphragm hernia or surgery.
- •11. Drug or alcohol abuse which would interfere with the subjectâ??s compliance.
- •12. Employee of study site, or spouse/partner or relative of an investigator or study staff.
- •13. Anticipated non-availability for study visits/procedures.
- •14. Surgery that can be considered as a planned intervention (e.g., cataract surgery) within the entire study period.
- •Obvious mental or physical incapacity to follow study procedures and investigator instructions adequately or to correctly practice inhalation and to use devices for inhalation.
- •16. Pregnant or nursing women.
- •17. Severe concomitant disease which may have an impact on the study participation.
- •Subjects with any history of premature birth less than 33 weeks gestation or significant level of respiratory care including mechanical ventilation required as neonate affecting the respiratory tract or chronic lung diseases, which in the opinion of the investigator or designated study personnel at site may interfere with the study evaluation or optimal participation in the study.
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