A Clinical Trial on the Treatment of Idiopathic Pulmonary Fibrosis
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Drug: TDI01 suspension
- Registration Number
- NCT06102083
- Lead Sponsor
- Beijing Tide Pharmaceutical Co., Ltd
- Brief Summary
This trial was performed in patients with idiopathic pulmonary fibrosis (IPF) to evaluate the clinical efficacy and safety of different doses of TDI01 Suspension, compared with control, for the treatment of patients with IPF.
- Detailed Description
This is a Phase II, multi-center, randomized, double-blinded, placebo-controlled clinical study to evaluate the efficacy and safety of TDI01 Suspension for the treatment of IPF. The study consists of a 4-week screening period, a 24-week treatment period, a 28-week extension period, and a 2-week safety follow-up period.
It is planned to include 120 IPF patients. All subjects will be randomized in a 1:1:1 ratio to receive a 24-week treatment with TDI01 Suspension dosage A, TDI01 Suspension dosage B, or the placebo. At Week 24, the subjects will be evaluated for the primary efficacy endpoints and subsequently enter the extension period. Subjects may continue receiving the investigational product until Week 52 at their voluntary consent.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group 1 TDI01 suspension TDI01 dose A, once daily Experimental group 2 TDI01 suspension TDI01 dose B, once daily Control group TDI01 suspension Placebo, once daily
- Primary Outcome Measures
Name Time Method Change From Baseline in Forced Vital Capacity (FVC) (mL) at Week 24 At 24 week The mean change in FVC (ml) from baseline at week 24, measured by spirometer
- Secondary Outcome Measures
Name Time Method Change From Baseline in FVC% Predicted From baseline up to week 52 The change in FVC as a percentage of expected value (FVC%) ffrom baseline measured by spirometer.
The time points which will be measured are from baseline to Week 12, Week 24, Extension Week 32, Extension Week 40, and Extension Week 52.Change From Baseline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % From baseline up to week 24 The Change of DLCO% with Hb correction measured by spirometer from baseline. The time point which will be measured are from baseline to Week 12 and Week 24.
Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) From baseline up to week 24 The mean change in 6MWD. The time points which will be measured are from baseline to Week 12 and Week 24.
Proportion of Subjects with an Absolute Decrease of FVC% Predicted Greater than 10% From baseline up to week 52 The proportion of subjects with an absolute decrease of FVC% greater than 10% measured by spirometer from baseline. The time point which will be measured are from baseline to Week 24, and Extension Week 52.
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation From baseline up to week 52 Time to first acute idiopathic pulmonary fibrosis exacerbation during the trial.
Time to Disease Progression From baseline up to week 52 Time to Disease Progression during the trial. Disease progression is defined as 10% absolute decrease in FVC, lung transplant or death, whichever occurs first.
The change in St.George's respiratory questionnaire（SGRQ） From baseline up to week 24 The mean change in total score of SGRQ from basline to Week 12 and Week 24. The SGRQ is a standardized self-completed questionnaire for measuring impaired health and perceived well-being in airways disease. It consists of multiple parts on different scales related to each question to assess the impact of respiration on the subject's life.
A total score is ranged from 0 (no health impairment) to 100 (maximum health impairment). The lower the better.