Safety and Tolerability of systemic administration of metformin in patients with Idiopathic Pulmonary Fibrosis (IPF): A randomized, placebo-controlled, double-blind, phase II proof-of-concept study (Met_for_IPF)

Conditions

Idiopathic pulmonary fibrosis

Brief summary

The primary endpoint is the mean difference in the absolute change from baseline in PRO-C3 release in serum (∆ PRO-C3) between both treatment groups as determined from the analysis of covariance (ANCOVA) model adjusting for baseline differences

Detailed description

Assessment of ∆ PRO-C3 between both treatment groups from randomization until the end of the follow-up period in accordance with the method used for assessment of the primary endpoint (see above)., Assessment of lung mechanics: Change in lung function over time: IVC, RV, IC, FEV1, FVC, TLC, sRaw effect and FEV1/FVC ratio, Assessment of exercise capacity and gas exchange over time : Change in exercise capacity: 6-minute walking test (6MWT) Change in partial pressure of O2 (pO2), change in O2 saturation between rest and exercise (at the end of the 6MWT), of CO2 (pCO2) Change in gas exchange: diffusion capacity for CO (DLCO, KCO), Assessment of changes in PRO-C6, C3M-HP, VICM, hsPRO-C4, CTX-III, SP-D, PAI-1 over time, Assessment of toxicity and safety during the course of the study until 4 weeks after the last dose of the medication: AEs, SAEs, Patient related outcome measures (PROMS): questionnaires KBILD, Leicester Cough and EQ-5D-5L over time

Related papers

No related papers found yet.

Interventions

DRUGP-Tabletten weiß 7 mm Lichtenstein

DRUGMetformin-ratiopharm 500 mg Filmtabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the mean difference in the absolute change from baseline in PRO-C3 release in serum (∆ PRO-C3) between both treatment groups as determined from the analysis of covariance (ANCOVA) model adjusting for baseline differences	—

Secondary

Measure	Time frame
Assessment of ∆ PRO-C3 between both treatment groups from randomization until the end of the follow-up period in accordance with the method used for assessment of the primary endpoint (see above)., Assessment of lung mechanics: Change in lung function over time: IVC, RV, IC, FEV1, FVC, TLC, sRaw effect and FEV1/FVC ratio, Assessment of exercise capacity and gas exchange over time : Change in exercise capacity: 6-minute walking test (6MWT) Change in partial pressure of O2 (pO2), change in O2 saturation between rest and exercise (at the end of the 6MWT), of CO2 (pCO2) Change in gas exchange: diffusion capacity for CO (DLCO, KCO), Assessment of changes in PRO-C6, C3M-HP, VICM, hsPRO-C4, CTX-III, SP-D, PAI-1 over time, Assessment of toxicity and safety during the course of the study until 4 weeks after the last dose of the medication: AEs, SAEs, Patient related outcome measures (PROMS): questionnaires KBILD, Leicester Cough and EQ-5D-5L over time	—

Measure

Time frame

Assessment of ∆ PRO-C3 between both treatment groups from randomization until the end of the follow-up period in accordance with the method used for assessment of the primary endpoint (see above)., Assessment of lung mechanics: Change in lung function over time: IVC, RV, IC, FEV1, FVC, TLC, sRaw effect and FEV1/FVC ratio, Assessment of exercise capacity and gas exchange over time : Change in exercise capacity: 6-minute walking test (6MWT) Change in partial pressure of O2 (pO2), change in O2 saturation between rest and exercise (at the end of the 6MWT), of CO2 (pCO2) Change in gas exchange: diffusion capacity for CO (DLCO, KCO), Assessment of changes in PRO-C6, C3M-HP, VICM, hsPRO-C4, CTX-III, SP-D, PAI-1 over time, Assessment of toxicity and safety during the course of the study until 4 weeks after the last dose of the medication: AEs, SAEs, Patient related outcome measures (PROMS): questionnaires KBILD, Leicester Cough and EQ-5D-5L over time

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Outcome results

None listed