Health Condition 1: J440- Chronic obstructive pulmonary disease with acute lower respiratory infection
Conditions
Interventions
Intervention1: Generic Tiotropium Bromide Inhalation Device of Cipla Ltd.: Dose as minimum of 3 to maximum of 8 consecutive inhalation
manoeuvres.
Mode of administration as Oral inhalation. For each s
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 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 criteria: - Post-bronchodilator FEV1/ Forced vital capacity (FVC) ratio of And Moderate - Post-bronchodilator FEV1 (within 15-30 minutes following intake of 400 mcg salbutamol) within the following range: 50% age, height and sex using the formula of the ECSC using appropriate correction factors for race Severe - Post-bronchodilator FEV1 (within 15-30 minutes following intake of 400 mcg salbutamol) within the following range: 30% 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 height and sex using the formula of the ECSC using appropriate correction factors for race. 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the peak inspiratory flow rate (PIFR) derived from inspiratory flow profiles generated by healthy adult subjects and adult subjects with moderate to very severe COPD through medication-free Generic Tiotropium Bromide Inhalation Device of Cipla and SPIRIVA® HandiHaler® device of Boehringer IngelheimTimepoint: Screening (Visit 1), Visit 2 (plus 5 days) and Visit 3 (plus 5 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare total inspiratory volume derived from flow profiles generated through these two medication free inhalers To assess correct use of the two inhalers through device handling assessment checklist To monitor the safety of subjectsTimepoint: Screening (Visit 1), Visit 2 (plus 5 days) and Visit 3 (plus 5 days) | — |
Countries
India
Contacts
Public ContactDr Bill Brashier
Cipla Ltd
Outcome results
None listed