| CTRI Number |
CTRI/2013/04/003520 [Registered on: 01/04/2013] Trial Registered Retrospectively |
| Last Modified On: |
26/02/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to assess whether Inhalational Bronchodilator given prior to bronchoscopy reduces discomfort due to breathlessness and cough |
|
Scientific Title of Study
|
Effect of pre-bronchoscopy inhaled bronchodilator ( salbutamol ) on procedure related outcomes in patients with airway obstruction. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anant mohan |
| Designation |
Associate professor medicine |
| Affiliation |
AIIMS new delhi |
| Address |
Dr.Anant mohan
Associate professor of medicine
Department of medicine
3rd floor teaching block
AIIMS
New Delhi
DELHI
110049
India |
| Phone |
9868397244 |
| Fax |
|
| Email |
anantmohan@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indrajit G Momin |
| Designation |
Junior Resident-Medicine |
| Affiliation |
AIIMS, New Delhi |
| Address |
Junior resident
Department of Medicine
3rd floor teaching block
AIIMS
Dr. Indrajit G Momin
House no. 475 2nd Floor
Hardevpuri, Gautam Nagar
New Delhi
South
DELHI
110049
India |
| Phone |
9013860043 |
| Fax |
|
| Email |
indrajitgmomin@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Indrajit G Momin |
| Designation |
Junior Resident-Medicine |
| Affiliation |
AIIMS, New Delhi |
| Address |
Junior resident
Department of Medicine
3rd floor teaching block
AIIMS
Indrajit G Momin
House no. 475 2nd Floor
Hardevpuri, Gautam Nagar
New Delhi
West
DELHI
110049
India |
| Phone |
9013860043 |
| Fax |
|
| Email |
indrajitgmomin@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Anant Mohan
Associate Prof Medicine
Dept of Medicine
AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Medicine AIIMS |
| Address |
Department of medicine
3rd floor teaching block
AIIMS New Delhi
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Randeep Guleria |
Prof Of Medicine
Dept of Medicine
AIIMS, New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Indrajit G Momin |
Department of Medicine |
Department of Medicine
AIIMS
New Delhi
South
DELHI |
9013860043
indrajitgmomin@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee/ethics sub-committee,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with any respiratory disease leading to FEV1/FVC less than 70%, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MDI Placebo ( Metered dose inhaler without the drug-salbutamol ) |
Dose 4 puffs of placebo
Duration single dose prior to bronchoscopy
Frequency single dose prior to bronchoscopy
Mode inhalation by metered dose inhaler with a spacer |
| Intervention |
MDI Salbutamol ( metered dose inhaler containing drug-salbutamol ) |
Dose 400 micrograms( 4 Puffs)
Duration single dose prior to bronchoscopy
Frequency single dose of 4 puffs prior to bronchoscopy
Mode inhalation by metered dose inhaler with a spacer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
â—¦ All patients undergoing fibreoptic bronchoscopy and having evidence of airway obstruction as assessed by spirometry i.e FEV1/FVC < 70 %
â—¦ Patients who give consent for the study
|
|
| ExclusionCriteria |
| Details |
Those who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
ï½ To determine whether use of inhaled bronchodilator prior to bronchoscopy provides a protective effect in patients with underlying airway obstruction.
|
Pulmonary Function Test will be done within 2 hours post bronchoscopy.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate whether this intervention ( MDI salbutamol ) has any beneficial effect on procedure related outcomes. |
questionnaires will be filled by patient regarding symptoms before and after Bronchoscopy. |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
29/09/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/09/2011 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients undergoing Bronchoscopy in Dept of Medicine who have FEV1/FVC < 70 will be recruited into the study. The recruited patients will then be randomized into two groups- Salbutamol Group and Placebo Group with the help of a list of computer generated open list of numbers. A detailed history will then be taken and general and systemic examination done . Based on the Group allocated ( Salbutamol Group or Placebo Group )15 to 20 mins prior to Bronchoscopy the patients will either receive a dose of salbutamol or the identical placebo with a Metered dose inhaler and spacer.Post Bronchoscopy Pulmonary Function Test will be done within 2 hours. Patients will also be required to fill a questionnaire regarding symptoms such as dyspnoea, cough, sputum production, before and after the procedure to assess whether there is any worsening of symptoms. |