CTRI/2021/09/036492
Completed
未知
A randomized, open-label, three-way crossover study tovalidate the SpirofyTM device (Cipla, pneumotach sensorbased spirometer) by comparing two SpirofyTM deviceswith the reference Vitalograph Alpha Touch standardspirometer (pneumotach sensor-based conventionalspirometer) in healthy, asthmatic and COPD subjects
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecifiedHealth Condition 2: J459- Other and unspecified asthma
- Sponsor
- Cipla Limited
- Enrollment
- 90
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects meeting the below mentioned criteria will be enrolled in the study:
- •1\. Healthy subjects or stable asthma patients or stable COPD patients
- •2\. Age ââ?°Â¥18 years
- •3\. Medical history / medical records showing evidence of diagnosed asthma or COPD for
- •these patients.
- •4\. No history of exacerbations of any disease since last 4 weeks
- •5\. No active or chronic respiratory complaints, normal clinical examination and normal
- •spirometry for healthy individuals.
- •6\. No history of upper or lower respiratory tract infection since last 4 weeks
- •7\. Subjects able to perform spirometry in accordance to 2019 ATS/ERS criteria with a
Exclusion Criteria
- •1\. Significant lung/airway diseases other than the asthma or COPD diagnosis for each of
- •the subject groups
- •2\. Any contraindications for spirometry as per ATS/ERS 2019 Guidelines as mentioned in
- •section 4\.4 of the protocol.
- •3\. Any significant deformity of the thorax or vertebral column that may cause persistent
- •airflow limitation or altered lung volumes
- •4\. Uncontrolled or unstable asthma / COPD status in the subjects
- •5\. Severe concomitant disease which may have an adverse impact on the spirometric
- •performance such as any unstable health conditions viz cardiovascular, pulmonary,
- •abdominal, neurological or any endocrine disorders
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
An investigator initiated study to study how well does a newly developed spirometer by Cipla Ltd. work as compared to the spirometer already available in the market.CTRI/2019/08/020738Chest Research Foundation
Completed
Phase 1
A clinical trial to determine relative bioavailability of single oral administration of two different formulations (capsule vs. tablet) of GRC 4039 and to study the food effect when tablets are administered in fasted and fed state in healthy male and female volunteers.CTRI/2009/091/000428Glenmark Pharmaceuticals SA, Chemin de la Combeta 5, 2300 La Chaux-de-Fonds, Switzerland
Completed
Not Applicable
A randomized, open-label, three-way crossover clinical trial to compare safety and pharmacokinetic characteristics after single administration of Carol-F Tab, Advil Liqui-Gels and Brufen Tab 200 mg in healthy male volunteersDiseases of the nervous systemKCT0002017Dong-A University Hospital36
Completed
Phase 1
A study to investigate the safety, tolerability and concentration in the blood of nicotine compared between different types of nicotine replacement therapies (NRTs)Smoking cessation and nicotine replacement therapies (NRT)Not ApplicableISRCTN17715270Ventus Medical Limited24
Completed
Not Applicable
An open*label, randomized, 3*period crossover study to determine the relative bioavailability of ASN120290 from a film*coated tablet given under fasted and fed conditions as compared to a capsule given under fasted conditions in healthy subjectsNL-OMON48189Asceneuron SA15