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
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Lung Disease Obstructive Sleep Apnea||Device: Auto-CPAP Other: Withdrawal of Auto-CPAP||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|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)|
|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|
Moderate to Severe OSA - treated
Moderate-to-severe OSA Treated with and adherent to 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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'.
- 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".
- 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.
- Gastroesophageal Reflux Disease Questionnaire (GERD-Q) [ Time Frame: 24 and 48 weeks ]GerdQ is a 6-item questionnaire to assess gastroesophageal reflux symptoms.
- 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.
- Concentration of CA125 (U/mL) [ Time Frame: Up to 48 Weeks ]continuous measure in blood
- Concentration of CA19-9 (U/mL) [ Time Frame: Up to 48 Weeks ]continuous measure in blood
- Concentration of Osteopontin (ng/mL) [ Time Frame: Up to 48 Weeks ]continuous measure in blood
- 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
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
|Contact: M. Atif Choudhury, BSfirstname.lastname@example.org|
|Contact: Onumara Opara, MPHemail@example.com|
|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 firstname.lastname@example.org|
|Contact: M. Atif Choudhury, BA 212-342-4551 email@example.com|
|Principal Investigator: Sanja Jelic, MD|
|Sub-Investigator: John S Kim, MD|
|Principal Investigator:||Sanja Jelic, MD||Columbia University|
|Study Chair:||Daniel J Gottlieb, MD||Brigham and Women's Hospital|