| CTRI Number |
CTRI/2018/05/014079 [Registered on: 23/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of the benefits and harm of indacaterol acetate and glycopyronium bromide with salmetrol and fluticasone in bronchial asthma patients. |
|
Scientific Title of Study
|
To assess and compare the efficacy and safety of indacaterol acetate and glycopyrronium bromide with salmetrol and fluticasone in patients of bronchial asthma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Md Hanzalah |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Pharmacology, J.N. Medical College
Aligarh Muslim University, Aligarh
Aligarh UTTAR PRADESH 202002 India |
| Phone |
9997012530 |
| Fax |
|
| Email |
drhanzalah2008@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Mohammad Nasiruddin |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Pharmacology, J.N. Medical College
Aligarh Muslim University, Aligarh
Aligarh UTTAR PRADESH 202002 India |
| Phone |
|
| Fax |
|
| Email |
naseer_bettiah@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Md Hanzalah |
| Designation |
Junior Resident |
| Affiliation |
J.N. Medical College, Aligarh Muslim University |
| Address |
Department of Pharmacology, J.N. Medical College
Aligarh Muslim University, Aligarh
Aligarh UTTAR PRADESH 202002 India |
| Phone |
|
| Fax |
|
| Email |
drhanzalah2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, UP-202002, INDIA |
|
|
Primary Sponsor
|
| Name |
Aligarh Muslim University |
| Address |
AMU, Aligarh-202002, India |
| 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 |
| Dr Md Hanzalah |
J. N. Medical College |
Aligarh Muslim University, Aligarh Aligarh UTTAR PRADESH |
9997012530
drhanzalah2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Faculty of Medicine, AMU, Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Bronchial asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 |
Indacatrol (150µg)+ Glycopyrronium (50µg) once a day for one month |
| Comparator Agent |
Group 2 |
Salmetrol (50µg) + Fluticasone (500µg) twice a day for one month |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients of stable asthma diagnosed clinically and spirometrically with complaints of chest tightness and coughing particularly at night or in the early morning.
2.All patients with documented diagnosis of asthma for a period of at least 1 year as per GINA guideline.
|
|
| ExclusionCriteria |
| Details |
1. Patients who had an asthma attack/exacerbation requiring systemic steroid/hospitalization.
2. Patients whoever had required intubation for severe asthma.
3. Patient’s clinical condition worsened by ICS administration.
4. Patients with a history of chronic lung disease other than asthma i.e. COPD, Sarcoidosis ,ILD
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spirometry |
0, 3rd, 7th, 14th & 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Renal function test, Hemogram,Liver function test |
0 & 28th day |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
19/05/2017 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
BRONCHIAL
ASTHMA:
Bronchial Asthma
is a chronic inflammatory disorder of the airway in which many cells and
cellular elements play a significant role in its causation.1The
chronic inflammation causes an increase in chest tightness and coughing
particularly at night or in early morning.2
These episodes are usually associated with widespread but variable airflow
obstruction that is often reversible either spontaneously or with treatment.
Inhaled β2-agonists
are the most effective bronchodilatorsfor the prevention and relief of
bronchoconstriction associated with asthma, and therefore have an important
role in managing asthma symptoms.8Long-acting β2-agonists ,such as salmeterol [3,9] and formoterol9, have 12-h durations of action, and their recommended use is in combination
with inhaled corticosteroids (ICS) in patients with moderate or severe
persistent asthma.9
Selective β2-agonists
were developed to minimize mediated chronotropic effects that were associated
with the non-selective agents such as isoprenaline. β2-receptors are
also present in myocardial tissue, and the occurrence of tachycardia and
palpitations has been associated with the use of older generation of selective
β2-agonists, especially at higher doses.Other dose-limiting β2-mediated
side effects include skeletal muscle tremor, hyperglycaemia and hypokalaemia.9Thus, an important property
of newer β2-agonists, is to provide effective bronchodilation at a
dose that is not associated with these side effects and to have a wide safety.
INDACATEROL
Indacaterol is a novel medicine given once-a-day
in a dosage form of dry powder inhaler, “twisthaler deviceâ€, and fast-acting β2-agonist
for the treatment of asthma and chronic obstructive pulmonary disease (COPD).7Preclinical
data suggests that, for a given degree of bronchodilator activity, indacaterol
has a greater cardiovascular safety margin than formoterol or salmeterol.10Indacaterol
maleate/acetate delivered by twisthaler in a dose of 150µg has been studied in
healthy volunteers,adult patients with COPD and asthma and found safe and well
tolerated.10
GLYCOPYRRONIUM
Glycopyrronium is anticholinergic drug.4It is a long-acting
bronchodilator and works by relaxing the airways in the lungs over about 24
hours, to make breathing easier. Glycopyrronium does not bring immediate relief; therefore it is not effective for sudden breathlessness .Glycopyrronium
is for inhalation only and must be used with Breezhaler. Common side effects of
glycopyrronium include dry mouth, insomnia, stomach cramps diarrhoea, vomiting,
nose and throat irritation and muscle or bone or joint pain. Glycopyrronium is a maintenance treatment
for people with controlled COPD (mild, moderate or severe).12 The effects from one inhaled dose of glycopyrronium 50 microgram (capsule)
should last for 24hours.Glycopyrronium are avoided: if there is allergic manifestation to the patient .Then other
anticholinergic drug; for example, a reliever such as ipratropium can be used. |