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Assessment of Continuous Positive Airway Pressure Therapy in IPF (ACT-IPF)

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ClinicalTrials.gov Identifier: NCT03901534
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sanja Jelic, Columbia University

Brief Summary:
The purpose of this study is to evaluate whether biomarkers of lung injury and remodeling are responsive to effective continuous positive airway pressure (CPAP) treatment in adults with idiopathic pulmonary fibrosis (IPF) and moderate-to-severe obstructive sleep apnea (OSA).

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Obstructive Sleep Apnea Device: Auto-CPAP Other: Withdrawal of Auto-CPAP Not Applicable

Detailed Description:

Idiopathic pulmonary fibrosis (IPF) is a progressive fibrotic disease of the peripheral lung parenchyma that affects 0.5% of older adults in the U.S. and confers a very poor median survival. Repetitive injury to the lung with abnormal healing likely results in fibrosis as treatment of those risk factors that cause these injuries may improve outcomes. Obstructive sleep apnea (OSA), a form of sleep disordered breathing, is highly prevalent in adults with IPF and may be a risk factor in IPF by exerting peripheral tractional stress on the lung and promoting oxidative injury by intermittent hypoxia. Effective treatment of OSA with continuous positive airway pressure (CPAP) reduces the number of obstructive events in OSA and therefore may reduce repetitive injury to the lung in adults with IPF.

Participants in this study will undergo polysomnography to determine whether they have OSA, and if so, its severity based on the apnea-hypopnea index (AHI, events/ hour). Those participants with moderate-to-severe OSA will undergo CPAP treatment for up to 48 weeks with an interim period of withdrawal of CPAP. The primary aim of this study will examine the effect of CPAP treatment and its withdrawal and re-initiation on biomarkers of lung injury and remodeling in adults with IPF and moderate-to-severe OSA who are adherent to CPAP (expected sample size for this group is 30). The study will stop enrollment after 30 participants in this group are enrolled.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Participants with moderate-to-severe OSA will be treated for 12 weeks with Auto-CPAP followed by withdrawal of auto-CPAP
Masking: None (Open Label)
Masking Description: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Continuous Positive Airway Pressure Therapy in IPF
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Moderate to Severe OSA - treated
Moderate-to-severe OSA Treated with and adherent to Auto-CPAP
Device: Auto-CPAP
Use of Auto-CPAP

Experimental: Moderate to Severe OSA - withdrawal
Moderate-to-severe OSA Withdrawal of Auto-CPAP
Other: Withdrawal of Auto-CPAP
Withdrawal of Auto-CPAP




Primary Outcome Measures :
  1. Serum matrix metalloproteinase-7 (MMP-7, ng/mL) [ Time Frame: Up to 24 Weeks ]
    The differences between-arm difference in the longitudinal changes of MMP-7 will be measured.

  2. Serum surfactant protein-D (SP-D, ng/mL) [ Time Frame: Up to 24 Weeks ]
    The between-arm difference in the longitudinal changes of SP-D will be measured.

  3. Serum Angiopoietin-2 (Ang-2, ng/mL) [ Time Frame: Up to 48 Weeks ]
    The between-arm difference in the longitudinal changes of Ang-2 will be measured.

  4. Serum surfactant protein-A (SP-A, ng/mL) [ Time Frame: Up to 24 weeks ]
    The between-arm difference in the longitudinal changes of SP-A will be measured.


Secondary Outcome Measures :
  1. Forced vital capacity (FVC) [ Time Frame: 24 and 48 weeks ]
    Forced vital capacity, or FVC, is defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.

  2. Diffusing capacity of the lung for carbon monoxide (DLCO) [ Time Frame: 24 and 48 weeks ]
    Diffusing capacity of the lungs for carbon monoxide (DLCO) is a medical test that determines how much oxygen travels from the alveoli of the lungs to the blood stream.

  3. Score on St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 24 and 48 weeks ]
    The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.

  4. Score on University of California San Diego (USCD) Shortness of Breath Questionnaire (SOBQ) [ Time Frame: 24 and 48 weeks ]
    The SOBQ is a a 24-item questionnaire that assesses self-reported shortness of breath while performing a variety of activities of daily living. Items are assessed on a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") for a total score ranging from 0 to 120.

  5. Score on Epworth Sleepiness Scale (ESS) [ Time Frame: 24 and 48 weeks ]
    The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

  6. Sleep Apnea Quality of Life Index (SAQLI) [ Time Frame: 24 and 48 weeks ]
    The SAQLI is a 35-item questionnaire is used to assess obstructive sleep apnea-related quality of life (QOL). Items are assessed on a 7-point scale with 0 indicating "all the time" to 7 indicating "not at all".

  7. Assess Quality of life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF) [ Time Frame: 24 and 48 weeks ]
    ATAQ-IPF is a 74-item questionnaire used to assess quality of life among adults with idiopathic pulmonary fibrosis.

  8. Gastroesophageal Reflux Disease Questionnaire (GERD-Q) [ Time Frame: 24 and 48 weeks ]
    GerdQ is a 6-item questionnaire to assess gastroesophageal reflux symptoms.

  9. Cough Visual Analog Scale [ Time Frame: 24 and 48 weeks ]
    Cough visual analog scale, a standardized scale ranging from 0 (no cough) to 100 (severe cough) on a continuous scale.


Other Outcome Measures:
  1. Concentration of CA125 (U/mL) [ Time Frame: Up to 48 Weeks ]
    continuous measure in blood

  2. Concentration of CA19-9 (U/mL) [ Time Frame: Up to 48 Weeks ]
    continuous measure in blood

  3. Concentration of Osteopontin (ng/mL) [ Time Frame: Up to 48 Weeks ]
    continuous measure in blood

  4. Moderate to Severe OSA Non-Adherent to CPAP [ Time Frame: Up to 10 years ]
    We will examine primary and secondary outcomes in participants with 1. Moderate-to-severe OSA who are not adherent to CPAP 2. No or Mild OSA



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent
  2. Age equal to or greater than 50 years
  3. Diagnosis of IPF as defined by the 2018 ATS/ERS/JRS/ALAT guidelines

Exclusion Criteria:

  1. Clinically significant lung disease other than IPF
  2. Planned change to the IPF treatment during the study period
  3. Known contraindication to CPAP
  4. Current use of CPAP, an oral appliance, or hypoglossal nerve stimulation for treatment of OSA
  5. Current cigarette smoking (past 4 weeks)
  6. Lower respiratory tract infection in the past 60 days. (Upper respiratory tract infection is not a contraindication)
  7. History of life-threatening cardiac arrhythmias
  8. Known chronic heart failure (Left ventricle ejection fraction < 45% or echo evidence of right ventricle dysfunction or pulmonary hypertension)
  9. Chronic opiate analgesic use
  10. History of stroke or spinal cord injury
  11. History of sleepiness-related automobile accident within past year of enrollment
  12. Expected survival time in the opinion of the investigator of less than 6 months
  13. Commercial driver's license or occupation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901534


Contacts
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Contact: M. Atif Choudhury, BS 212-342-4551 mac2463@cumc.columbia.edu
Contact: Onumara Opara, MPH 212-342-4167 ono2107@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Onumara Opara, MPH    212-342-4167    ono2107@cumc.columbia.edu   
Contact: M. Atif Choudhury, BA    212-342-4551    mac2463@cumc.columbia.edu   
Principal Investigator: Sanja Jelic, MD         
Sub-Investigator: John S Kim, MD         
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Sanja Jelic, MD Columbia University
Study Chair: Daniel J Gottlieb, MD Brigham and Women's Hospital

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Responsible Party: Sanja Jelic, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03901534     History of Changes
Other Study ID Numbers: AAAR6902
1R01HL137234-01 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Researchers will be required to submit a written request to Dr. Lederer describing the use of the specimens. The researcher must also document institutional review board (IRB) approval and sign a material transfer agreement. Dr. Lederer will make all decisions about use of the specimens. No identifiable information will be released, only coded anonymized samples and non-identifiable clinical/demographic information. For genomic data generated from whole-exome sequencing, the genotype and relevant phenotype data for participants who consented to share data will be registered and shared through the database of Genotypes and Phenotypes (dbGaP), a controlled access database, once the sequencing data have been cleaned and quality control procedures are completed.
Supporting Materials: Study Protocol
Time Frame: Data will be available no later than 3 years after last research subject is enrolled in the study.
Access Criteria: Researchers will be required to submit a written request to Dr. Lederer describing the use of the specimens. The researcher must also document IRB approval and sign a material transfer agreement. Dr. Lederer will make all decisions about use of the specimens. No identifiable information will be released, only coded samples and non-identifiable clinical/demographic information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sanja Jelic, Columbia University:
Interstitial Lung Disease (ILD)
Idiopathic Pulmonary Fibrosis (IPF)
Obstructive Sleep Apnea (OSA)
CPAP
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Lung Diseases
Lung Diseases, Interstitial
Respiration Disorders
Respiratory Tract Diseases
Dyssomnias
Nervous System Diseases