NCT01714934

Brief Summary

The pathogenesis of idiopathic pulmonary fibrosis (IPF) is debatable. Looking for an insult to lung parenchyma that generates the pathogenesis of the disease is challenging. Pepsin is a proteolytic enzyme present in the gastric juice. Microaspirations of gastric content were described as a potential factor for injury in many chronic lung disorders. Bronchoalveolar lavage (BAL) is a routine investigation technique in interstitial lung diseases. The presence of pepsin in the BAL fluid recovered from patients with IPF may indicate a possible role for gastric microaspirations in the pathogenesis of the disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

1.4 years

First QC Date

October 23, 2012

Last Update Submit

October 25, 2012

Conditions

IDIOPATHIC PULMONARY FIBROSIS

Keywords

IDIOPATHIC PULMONARY FIBROSISMICROASPIRATION

Outcome Measures

Primary Outcomes (1)

  • BAL Pepsin level

    18 MONTHS

Study Arms (2)

IPF

IPF patients diagnosed according to clinical and radiological findings

NON IPF

Other interstitial lung diseases such as sarcoidosis or hypersensitivity pneumonitis diagnosed as per clinical and radiological findings

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with IPF versus patients with other interstitial lung disorders (non IPF)

You may qualify if:

  • patients with interstitial lung disorders including IPF

You may not qualify if:

  • patients younger than 18 years or older than 85,
  • pregnant women,
  • patients that present with medical conditions contra -indicated for performing bronchoscopy including sedation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Biospecimen

BAL broncho alveolar lavage at bronchoscopy

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 26, 2012

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

October 26, 2012

Record last verified: 2012-10

Locations

IL(1)