Health TrialsbyHealthPanel

Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis

ConditionPneumoconiosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Continent Pharmaceutical Co, Ltd.

About this trial

This study is a randomized, double-blind, placebo-controlled, multicenter clinical study.

The main purpose of this study was to confirm the efficacy and safety of pirfenidone capsules in the treatment of pneumoconiosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age 18~70 years old (including 18 years old and 70 years old), gender is not limited.

Disqualifiers

1. Those who do not meet any of the inclusion criteria. 2. Those who have received lung lavage therapy within 3 months and plan to receive lung lavage therapy during the trial.

Severe hypertension within 6 weeks and uncontrolled with treatment (≥160/100 mmHg);

Myocardial infarction within 6 months;

Unstable angina within 6 months. 10. Coagulation parameters: International normalized ratio (INR) > 2, prothrombin time (PT) prolongation > 1.5 times ULN.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pirfenidone Capsules

    Drug

    After randomization, the experimental group took pirfenidone capsules 3 times a day，Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time

  • placebo capsules

    Drug

    After randomization, the experimental group took placebo capsules 3 times a day，Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time

Treatment groups

272 Participants
are divided into 2 treatment groups
Group A: Pirfenidone groupExperimental treatment 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in pulmonary function FVC%

Change in FVC % (FVC % predicted) at 52 weeks of treatment

Time frame
52 weeks

Secondary outcomes

1

Pulmonary function FVC

Changes in FVC (L) at 52 weeks of treatment

Time frame
52 weeks
2

Changes in lung function DLco%

Change in DLco% at 52 weeks of treatment

Time frame
52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Continent Pharmaceutical Co, Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now