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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 device”, 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.

 
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