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A study Testing whether the addition of inhaler therapy can Improve Breathing in Patients with Interstitial Lung Disease (ILD)

A prospective study to assess the efficacy of extra fine particle inhaled corticosteroid and LABA in small airway diseases associated with interstitial lung diseases - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094119
Enrollment
30
Registered
2025-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J849- Interstitial pulmonary disease, unspecified

Interventions

Intervention1: Formoterol and beclomethasone: Formoterol fumarate (6mcg) and beclomethasone dipropionate (100mcg)- combination- via Extra fine particle Metered dose inhaler with spacer - Twice a day f

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All diagnosed patients of interstitial lung diseases attending the ILD special clinic with small airway disease as diagnosed by FEF25-75% <65%.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 diseaseTimepoint: 8 weeks

Secondary

MeasureTime frame
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 diseasesTimepoint: 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 diseaseTimepoint: 8 weeks

Countries

India

Contacts

Public ContactDr Naveen Dutt

All India Institute of Medical Sciences

drnaveendutt@yahoo.co.in8003996863

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026