Pinpointing the Factors Affecting Clinical Study Experiences of Pulmonary Fibrosis Patients

NCT05899556 | Not Yet Recruiting

• 1 other identifier: 83217345
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Fibrosis

Keywords

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (2)

• Number of pulmonary fibrosis patients who decide to participate in a clinical study

  3 months

• Rate of patients who remain in an pulmonary fibrosis clinical study to completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with pulmonary fibrosis who are actively participating in a clinical research, but have not yet completed enrollment and randomization.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related 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.

  PMID: 28257817 BACKGROUND

• 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.

  PMID: 35001525 BACKGROUND

• 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.

  PMID: 26020856 BACKGROUND

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

4159004227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 12, 2023

Record last verified: 2023-06

Locations

US (1)