CTRI/2019/12/022280已完成未知
A randomized, open-label, two-way crossover study to compare inspiratory flowprofiles generated with medication-free Generic Tiotropium Bromide Inhalation Device of Cipla Ltd. andSPIRIVA® HandiHaler® device of Boehringer Ingelheim in healthy adult subjects and adult subjects with moderate tovery 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
- •Healthy adult subjects
- •1. Male and female healthy adult subjects of any ethnic origin, aged 18 to 55 years (inclusive).
- •2. Signed and dated written informed consent.
- •3. Forced vital capacity (FVC) >80%, Peak Expiratory Flow Rate (PEFR) >80%, Forced
- •expiratory volume in one second (FEV1) >80% of that predicted by the European Coal and
- •Steel Community (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
- •4. Oxygen saturation >= 95%
- •5. No history of chronic airway disease, no current evidence of upper or lower respiratory
- •tract infection.
- •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 study.
- •7. 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 patients with COPD
- •1. Male and female subjects of any ethnic origin, aged 40 to <= 80 years
- •2. Signed and dated written informed consent
- •3. 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 6 months prior to Screening and who meet the following
- •- 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
- •- 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
- •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
- •Note: For calculation of predicted values, other equations used in Caucasians can be
- •used interchangeably with ECSC formula
- •4. 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
- •5. The smokers or ex-smokers having history of >= 10 pack years [pack years is equal to (average
- •number of cigarettes per day/20) x years of smoking] prior to Screening
排除标准
- •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.
- •15. 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.
- •18. Patients 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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