| CTRI Number |
CTRI/2023/08/056631 [Registered on: 18/08/2023] Trial Registered Prospectively |
| Last Modified On: |
15/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of different inhalers in patients of chronic obstructive pulmonary disease |
|
Scientific Title of Study
|
Evaluation of effectiveness of different inhalers in patients of chronic obstructive pulmonary disease |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vibhu Pandey |
| Designation |
Junior Resident |
| Affiliation |
JNMCH, AMU, ALIGARH |
| Address |
Department of Pharmacology, JNMC, AMU, Aligarh
Medical Road, Aligarh Muslim University, aligarh, U.P.-202001
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9156517567 |
| Fax |
|
| Email |
drvibhupandey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jameel Ahmad |
| Designation |
Assistant Professor |
| Affiliation |
JNMCH, AMU, ALIGARH |
| Address |
Department of Pharmacology, JNMC, AMU, Aligarh
Medical Road, Aligarh Muslim University, aligarh, U.P.-202001
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7599529550 |
| Fax |
|
| Email |
ahmad.drjameel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vibhu Pandey |
| Designation |
Junior Resident |
| Affiliation |
JNMCH, AMU, ALIGARH |
| Address |
Department of Pharmacology, JNMC, AMU, Aligarh
Medical Road, Aligarh Muslim University, aligarh, U.P.-202001
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9156517567 |
| Fax |
|
| Email |
drvibhupandey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh, U.P.-202001 |
|
|
Primary Sponsor
|
| Name |
JNMCH, AMU, Aligarh |
| Address |
Medical road, amu, aligarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vibhu Pandey |
Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh |
Outpatient department (OPD),Department of Tuberculosis and Chest Diseases
Aligarh
UTTAR PRADESH |
9156517567
drvibhupandey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J44||Other chronic obstructive pulmonary disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of COPD as per GOLD GUIDELINES, patients having age more than 18 years |
|
| ExclusionCriteria |
| Details |
Complicated cases of COPD, patients with respiratory failure, patients with clinically significant lung disease other than COPD, Patients on systemic corticosteroid therapy, history of MI and Heart failure, pregnant and lactating mothers, psychiatric patients, immunocompromised patients, HIV HBsAg,Anti-HCV positive, unable to take drugs using above techniques |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| measurement of FEV1/FVC ratio |
baseline, 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in number of rescue medication , use and compliance to different inhaler devices |
three months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic Obstructive Pulmonary Disease is characterised by persistent airflow limitation and respiratory symptoms that are due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. COPD is the fourth leading cause of death and it affects more than 10 million persons in the United States. The prevalance of COPD in India is reported to be 7.4%. Inhaled therapy is the mainstay of COPD treatment, and direct delivery of medication to the lung allows for optimal efficacy and safety. Deposition of inhaled drugs is sensitive to the brething pattern of patients which also depends on disease severity. These characteristics impact the patient’s ability to properly use specific inhaler devices and therefore affect adherence to therapy, therapeutic outcomes and quality of life. Worsening symptoms or increased frequency of exacerbations may not always indicate disease progression but may indicate the improper use of an inhaler device. Improper handling of the inhaler device may cause decreased pulmonary aerosol drug deposition and low therapeutic effects. The more efficient, user friendly delivery devices may increase clinical effectiveness and patient compliance. Therefore, formulation improvements and new device technologies have been developed through an improved understanding of the mechanisms of aerosolization and lung deposition. New emerging device technologies on minimising patient errors, expanding the range of inhaled drugs, improving delivery efficiency, increasing dose consistency and dosage levels, thus, simplifying device operation. pMDI, DPI, BA-MDI will be used for the comparison. In comparison with a pMDI, BAIs have demonstrated consistent lung deposition not only in patients with good hand-mouth coordination but also in patients with poor hand-mouth coordination while using a pMDI. However the studies conducted on novel BAI are limited particularly in our country India. The present study is designed to evaluate the clinical effectiveness of different inhaler devices in the delivery of inhaled corticosteroids and beta 2 agonists for patients with COPD. It will include the effectiveness of device handling, ease of use, errors, and participant perception regarding BA-MDI, pMDI and DPI in patients with COPD. The present study is prospective, open labelled and observational. It will be conducted on patients of chronic obstructive lung disease attending the IPD or OPD of Tuberculosis and Chest Diseases, J.N.Medical College & Hospital, A.M.U., Aligarh. The final diagnosis of COPD will be made based on the Global Initiative fro Lung Disease (GOLD) 2022 severity classification. The patients of COPD of age more than 18 years will be included. Written Informed consent will be taken from all enrolled patients. Only those patients who are fulfilling the inclusion and exclusion criteria will be grouped and analysed at the end of study. Follow up of the patients will be done at two weeks interval till three months. The patients will be assessed on the paarmeters : PFT, SGRQs, Device handling and Ease of use questionnaire responses, etc. |