Health Condition 1: J440- Chronic obstructive pulmonary disease with acute lower respiratory infection
Conditions
Interventions
Intervention1: Medication-free CIPLA Dry Powder Inhaler (DPI): For each subject, during the PIFR measurement through DPI analyzer, the technician should be advised to take 5-8 consecutive inspiratory
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects of any ethnic origin, aged 40 to 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 And Moderate - Post-bronchodilator FEV1 (within 15-30 minutes following intake of 400 mcg salbutamol) within the following range: 50% OR Severe - Post-bronchodilator FEV1 (within 15-30 minutes following intake of 400 mcg salbutamol) within the following range: 30% OR Very severe - Post-bronchodilator FEV1 (within 15-30 minutes following intake of 400 mcg salbutamol) within the following range: FEV1 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 7. The smokers or ex-smokers having history of >= 10 pack years prior to screening
Exclusion criteria
Exclusion criteria: 1 Requirement for oral/injectable steroid therapy due to unstable disease within the last 2 months prior to screening 2 Significant lung/airway diseases other than COPD 3 Subjects who are not considered eligible after evaluation by investigator as per Covid-19 diagnostic protocol at site 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 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 as assessed by investigator 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
Secondary
| Measure | Time frame |
|---|---|
| Pressure drop (kpa) generated through the respective DPIs Inhaled volume (L) generated through the respective DPIs Timepoint: Pressure drop (kpa) generated through the respective DPIs Inhaled volume (L) generated through the respective DPIs | — |
Primary
| Measure | Time frame |
|---|---|
| Peak inspiratory flow rate (L/min, PIFR) generated through the respective DPIs.Timepoint: Peak inspiratory flow rate (L/min, PIFR) generated through the respective DPIs once subject is randomized in the study | — |
Countries
India
Contacts
Public ContactDr Swapnil Jamdade
Cipla limited
Outcome results
None listed