The clinical trial to assess inspiratory flow profiles generated with medication-free CIPLA Dry Powder Inhaler and Seretide Accuhaler in healthy, moderate to severe asthma, moderate to severe chronic obstructive pulmonary disease patients.
- Conditions
- Health Condition 1: J40-J47- Chronic lower respiratory diseases
- Registration Number
- CTRI/2018/10/016022
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Healthy adult subjects: 1. Male and female healthy adult subjects of any ethnic origin, aged from 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 >= 0.75.4. Oxygen saturation >= 95 % .5. Subjects who have not taken any drugs within 2 days prior to screening.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.
Children with asthma
1. Male and female children of any ethnic origin, aged from 4 to <18 years .2. Ability and willingness to participate in the study.
3. Informed Consent, signed and dated by parents (or legal representatives) and documented assent by the child.4. Diagnosis of asthma based on physician diagnosis/PEFR reversibility/spirometry reversibility/Clinical history and symptoms of asthma for minimum of 6 months prior to screening.5. Treatment with any asthma medication (including inhaled corticosteroid) at a constant dosage during four (4) weeks prior to inclusion in study
6. Non-smoker
Adult patients with asthma
1. Male and female subjects of any ethnic origin, aged 18 years or more.2. Signed and dated written informed consent.3. Established diagnosis of asthma (according to GINA 2003 asthma severity based on lung physiology) for at least 6 months prior to Screening visit and who meet the following criteria:- Pre-bronchodilator FEV1 between 60 % and 80 % (not inclusive) of the predicted value for age, height and sex using the form ula of the European Coal and Steel Community (ECSC) using appropriate correction factors for race
OR - Pre-bronchodilator FEV1 of <= 60% of the predicted value for age, height and sex using the formula of the European Coal and Steel Community (ECSC) using appropriate correction factors for race AND - Historic evidence of reversibility performed as per ATS guideline of within 12 months before screening. If historic evidence not available, reversibility, defined as an increase in FEV1 of >= 12 % and >= 200 mL from baseline within 15-30 minutes following intake of 400 mcg salbutamol, administered from an Metered Dose Inhaler, as measured during Screening.4.Regular treatment with inhaled asthma medication at a constant dosage during the last four (4) weeks prior to Screening (Visit 1).5.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.
1. Acute exacerbation of bronchial asthma or COPD or hospitalization/emergency room visits due to asthma/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 asthma or COPD diagnosis for each of the subject groups.
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 asthma or 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 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
19. Subject unable to perform acceptable inhalation manoeuvers during the training on Cipla DPI device at screening visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak inspiratory flow rate (L/min, PIFR) generated through the respective DPIs. <br/ ><br>The inspiratory flow profiles will be recorded and stored as source data.Timepoint: visit 2
- Secondary Outcome Measures
Name Time Method Safety Assessment: <br/ ><br>ï?· Vital signs (oral body temperature, blood pressure, pulse and respiratory rate). <br/ ><br>ï?· Clinically significant findings from physical examination assessment. <br/ ><br>ï?· Incidence and occurrence of AEs.Timepoint: Visit 2