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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05899556
Other study ID # 83217345
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2024
Est. completion date July 2026

Study information

Verified date June 2023
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone 4159004227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Taking part in clinical trials usually favors a particular demographic group. But there is limited research available to explain what research attributes affect the completion of these specific demographic groups. This study will admit a wide range of data on the clinical trial experience of pulmonary fibrosis patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future pulmonary fibrosis patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date July 2026
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient is at least 18 years of age - Diagnosis of pulmonary fibrosis - Ability to understand the study procedures, benefits and risks, and sign a written informed consent document. Exclusion Criteria: - Enrolled in another research study - Inability to provide written informed consent - Women of childbearing potential without a negative pregnancy test; or women who are lactating.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Power Life Sciences San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Aiello M, Bertorelli G, Bocchino M, Chetta A, Fiore-Donati A, Fois A, Marinari S, Oggionni T, Polla B, Rosi E, Stanziola A, Varone F, Sanduzzi A. The earlier, the better: Impact of early diagnosis on clinical outcome in idiopathic pulmonary fibrosis. Pulm Pharmacol Ther. 2017 Jun;44:7-15. doi: 10.1016/j.pupt.2017.02.005. Epub 2017 Feb 28. — View Citation

Glass DS, Grossfeld D, Renna HA, Agarwala P, Spiegler P, DeLeon J, Reiss AB. Idiopathic pulmonary fibrosis: Current and future treatment. Clin Respir J. 2022 Feb;16(2):84-96. doi: 10.1111/crj.13466. Epub 2022 Jan 10. — View Citation

O'Riordan TG, Smith V, Raghu G. Development of novel agents for idiopathic pulmonary fibrosis: progress in target selection and clinical trial design. Chest. 2015 Oct;148(4):1083-1092. doi: 10.1378/chest.14-3218. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of pulmonary fibrosis patients who decide to participate in a clinical study 3 months
Primary Rate of patients who remain in an pulmonary fibrosis clinical study to completion 12 months
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