Effect of Calcium Channel Blocker Therapy in Idiopathic Pulmonary Fibrosis

Lead Investigator: Rayid Abdulqawi, King Faisal Specialist Hospital and Research Centre
Title of Proposal Research: Effect of Calcium Channel Blocker Therapy in Idiopathic Pulmonary Fibrosis
Vivli Data Request: 8815
Funding Source: Saudi NIH
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Idiopathic Pulmonary Fibrosis (IPF) is a chronic lung disease that leads to significant loss of function in patients. Although there are approved medications that have been shown to slow disease progression, the prognosis of IPF remains poor and for the majority of patients affected is rapidly fatal. IPF is a relatively rare disorder with varying estimates of its prevalence and incidence across countries with reported prevalences ranging from 13 to 20 per 100,000 worldwide. IPF is generally caused by an injury to the cells lining the alveolar (the small air sacs in the lungs where oxygen and cardon dioxide exchange occurs with the blood). Injury to these cells can trigger the release of growth factors which cause scarring and thickening of the lung tissues (fibrosis), making breathing more difficult. Calcium is believed to play a role in this process.

Calcium channel blockers (CCBs), which prevent calcium from entering the cells, have commonly been used for high blood pressure and arrythmias (where the heart is beating too fast or slow) since the 1960s. Recent research has suggested that CCBs might also have the potential to prevent the development of lung scarring. For example, in studies conducted on animals, a specific CCB called nifedipine has been found to reduce lung scarring.

We want to investigate whether IPF patients who were already taking CCBs during randomized clinical trials had better outcomes compared to those who were not taking CCBs. The primary outcome measure chosen for this investigation is lung function (forced vital capacity) change, which serves as a surrogate marker for IPF progression. Our plan is to evaluate the changes in lung function from the baseline to the end of the study for individuals with and without CCBs at baseline in the placebo groups of the requested phase 3 controlled clinical trials. To account for the complexity of the data, we intend to employ a multi-level modeling test. This statistical approach allows for the analysis of repeated measures within patients, considering that multiple measurements are taken over time. Additionally, it accounts for the presence of multiple patients within each trial and multiple trials in the overall analysis.

Since the outlook for IPF patients is often quite grim, even a small improvement in survival with the help of interventions like CCBs would be highly significant. This is why we are motivated to explore this possibility further through our proposal.

Requested Studies:

A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)
Data Contributor: Roche
Study ID: NCT01366209
Sponsor ID: PIPF-016

A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Data Contributor: Roche
Study ID: NCT00287729
Sponsor ID: PIPF-006

A Randomized, Double-Blind, Placebo Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Data Contributor: Roche
Study ID: NCT00287716
Sponsor ID: PIPF-004

A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Data Contributor: Boehringer Ingelheim
Study ID: NCT01335477
Sponsor ID: 1199.34