Inhaled NAC in Treatment of IPF | NCT03720483

Studies
Inhaled NAC in Treatment of IPF

NCT03720483

Sponsor

University of Colorado, Denver

Status

Withdrawn

Last Update Posted

Jun 8, 2021Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Interventions

N-acetyl cysteine then Placebo
Placebo then N-acetyl cysteine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study encountered challenges during startup due to the COVID-19 epidemic and was withdrawn.

Expanded Access Info

Start Date

Jan 2022Estimated

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Jul 18, 2018

First Submission Date that Met QC Criteria

Oct 23, 2018

First Posted Date

Oct 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2021

Last Update Posted Date

Jun 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. The study will also create a bank of data, blood, and sputum from IPF patients for future research.

Detailed Description

NAC is a medication used to loosen thick mucus. NAC was initially licensed for use in 1968. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system, and it is available as a generic medication and is not very expensive. Inhaled NAC has been used as a mucus-dissolving therapy in respiratory conditions with excessive and/or thick mucus production.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
N-acetyl cysteine then placebo	Experimental	This arm will receive NAC followed by placebo	Drug: N-acetyl cysteine then Placebo
Placebo then N-acetyl cysteine	Experimental	This arm will receive placebo followed by NAC	Drug: Placebo then N-acetyl cysteine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N-acetyl cysteine then Placebo	Drug	Subject will receive N-acetyl cysteine first followed by Placebo	N-acetyl cysteine then placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in Pulmonary function - FVC	Measure changes in percent predicted FVC	Baseline, week 10, and week 18
Changes in Pulmonary function - DLCO	Measure changes in percent predicted DLCO	Baseline, week 10, and week 18

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed by study team with expertise in IPF utilizing standard ATS/ERS definition of "probable" or "definite" IPF
DLCO >50% predicted
FVC >60% predicted
FEV1/FVC > 0.7

Exclusion Criteria:

History of bronchospasm (requiring treatment)
Current acute exacerbation of their IPF disease
Current smoker
Supplemental O2 requirement > 4 liters/min via nasal cannula
History of asthma, COPD, coronary artery disease, or cancer
Currently using NAC, hypertonic saline, or DNase (dornase alfa) inhalation therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Steele, MD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Anschutz Medical Campus		Aurora	Colorado	80045	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054990	Idiopathic Pulmonary Fibrosis

Ancestor Terms

ID	Term
D011658	Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided