Efficacy and Safety of Early Antifibrotic Therapy for Non-progressive Fibrotic Interstitial Lung Disease

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-85
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

Early antifibrotic therapy for f-ILD

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients with unstable disease (IPF) assessed by investigators during screening had acute exacerbations during screening or within 3 months before randomization;

Patients who are likely to require lung transplantation within 6 months or whose expected survival is less than 1 year as assessed by the investigators at the time of screening;

During screening, chest HRCT indicated that the range of emphysema exceeded the range of pulmonary fibrosis (based on independent imaging evaluation results);

Patients with airway obstruction disease (such as FEV1/FVC after bronchodilator);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Antifibrotic drugs (nidanib or pirfenidone)

    Drug

    One group received primary therapy, and another group received an antifibrotic drug (nidanib or pirfenidone) in addition to primary therapy.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Antifibrotic drugActive comparator 1 intervention
Group B: Primary therapy groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

FVC %predict

Time frame
48 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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