The clinical trial to assess inspiratory flow profiles generated with medication-free Generic Tiotropium Bromide Inhalation Device and SPIRIVA® HandiHaler® device in healthy adult subjects and chronic obstructive pulmonary disease patients
- Conditions
- Health Condition 1: J440- Chronic obstructive pulmonary disease with acute lower respiratory infection
- Registration Number
- CTRI/2019/12/022280
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 104
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
criteria:
- Post-bronchodilator FEV1/ Forced vital capacity (FVC) ratio of < 70 %
And
Moderate
- 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
Severe
- 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.
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the peak inspiratory flow rate (PIFR) derived from <br/ ><br>inspiratory flow profiles generated by healthy adult subjects and adult <br/ ><br>subjects with moderate to very severe COPD through medication-free Generic Tiotropium Bromide Inhalation Device of Cipla and <br/ ><br>SPIRIVA® HandiHaler® device of Boehringer IngelheimTimepoint: Screening (Visit 1), Visit 2 (plus 5 days) and Visit 3 (plus 5 days)
- Secondary Outcome Measures
Name Time Method To compare total inspiratory volume derived from flow profiles generated through these two medication free inhalers <br/ ><br>To assess correct use of the two inhalers through device handling assessment checklist <br/ ><br>To monitor the safety of subjectsTimepoint: Screening (Visit 1), Visit 2 (plus 5 days) and Visit 3 (plus 5 days)