| CTRI Number |
CTRI/2025/09/094119 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study Testing whether the addition of inhaler therapy can Improve Breathing in Patients with Interstitial Lung Disease (ILD)" |
|
Scientific Title of Study
|
A prospective study to assess the efficacy of extra fine particle inhaled corticosteroid and LABA in small airway diseases associated with interstitial lung diseases |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saktheesh R |
| Designation |
Senior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 32, ‘B’ Block-Ground Floor, OPD Building, Department of Pulmonary Medicine, All India Institute of Medical Sciences, Basni, Industrial Area Phase II, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9655504686 |
| Fax |
|
| Email |
saktheeshr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveen Dutt |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 32, ‘B’ Block-Ground Floor, OPD Building, Department of Pulmonary Medicine, All India Institute of Medical Sciences, Basni, Industrial Area Phase II, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996863 |
| Fax |
|
| Email |
drnaveendutt@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen Dutt |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 32, ‘B’ Block-Ground Floor, OPD Building, Department of Pulmonary Medicine, All India Institute of Medical Sciences, Basni, Industrial Area Phase II.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996863 |
| Fax |
|
| Email |
drnaveendutt@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Basni, Industrial Area Phase II, Jodhpur, Rajasthan, India Pincode-342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences, Basni, Industrial Area Phase II, Jodhpur, Rajasthan, India.
Pin code 342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Saktheesh R |
All India Institute of Medical Sciences |
Room No 32, ‘B’ Block-Ground Floor- OPD Building, Department of Pulmonary Medicine, All India Institute of Medical Sciences, Basni, Industrial Area Phase II, Jodhpur.Pincode:342005
Jodhpur
RAJASTHAN |
09655504686
saktheeshr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J849||Interstitial pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Formoterol and beclomethasone |
Formoterol fumarate (6mcg) and beclomethasone dipropionate (100mcg)- combination- via Extra fine particle Metered dose inhaler with spacer - Twice a day for 8 weeks |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All diagnosed patients of interstitial lung diseases attending the ILD special clinic with small airway disease as diagnosed by FEF25-75% <65%. |
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate in the study, Coexisting other diagnoses that may cause an obstructive pattern in PFT, Patients are unable to use the MDI as trained, Within one month of acute exacerbation or requiring an increase in steroid /immunosuppression dose during the study period of 8 weeks, Within one month of any upper/ lower respiratory tract infections requiring treatment modifications, Patients not giving consent for the study, Patients having contraindications for the use of inhaled corticosteroids and Patients who are actively smoking.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in FEF 25%-75% with the addition of extra fine particle inhaled corticosteroids and bronchodilators in patients of interstitial lung diseases associated with small airway disease |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the level of improvement in symptom scores (K-BILD) with addition of ICS and inhaled LABA to the standard treatment regimen in patients of various interstitial lung diseases |
8 weeks |
| Change in RV/TLC with the addition of extra fine particle inhaled corticosteroids and bronchodilators in patients of interstitial lung diseases associated with small airway disease |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/10/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Following Clinical Trials Registry-India (CTRI) approval, we
will commence a prospective, single-arm interventional trial, recruiting
patients over 8 months from our specialized Interstitial Lung Disease
(ILD) clinic at out institute, AIIMS, Jodhpur. Eligible participants will be
adults with a confirmed diagnosis of ILD and evidence of small airway disease
(SAD), defined as a pre-bronchodilator FEF25-75% < 65% predicted. Key
exclusion criteria will include active smoking, co-existing obstructive lung
diseases (e.g., asthma, COPD), an acute ILD exacerbation or respiratory
infection within one month of enrollment, inability to correctly use the
inhaler device, or known contraindications to the study medication. After
baseline assessments, including full pulmonary function tests and the King’s
Brief Interstitial Lung Disease (K-BILD) questionnaire, all enrolled patients
will be prescribed an extra-fine particle combination inhaler (formoterol and
beclomethasone) for a duration of 8 weeks, in addition to their standard ILD
therapy. The primary outcome will be the change in FEF25-75% from baseline to
the 8-week follow-up, with secondary outcomes including changes in the K-BILD
score and RV/TLC. We anticipate that this targeted treatment will yield a
statistically and clinically significant improvement in small airway function
and patient-reported symptoms. If successful, the findings from this study will
provide crucial evidence to support a more comprehensive management strategy
for ILD that addresses the airway component of the disease, potentially
establishing a new standard of care to improve functional capacity and quality
of life for this patient population and justifying larger, randomized
controlled trials in the future.
|