Assessment of Continuous Positive Airway Pressure Therapy in IPF

Obstructive Sleep Apnea Clinical Trial

— ACT-IPF  

Official title:

Assessment of Continuous Positive Airway Pressure Therapy in IPF

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03901534
• Other study ID #: AAAR6902
• Secondary ID: 1R01HL137234-01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Columbia University
• Contact: Alondra Jimenez Holguin
• Phone: 212-342-0256
• Email: aj2886[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Auto-CPAP
Use of Auto-CPAP

Other:
• Withdrawal of Auto-CPAP
Withdrawal of Auto-CPAP

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concentration of CA125 (U/mL)	continuous measure in blood	Up to 48 Weeks
Other	Concentration of CA19-9 (U/mL)	continuous measure in blood	Up to 48 Weeks
Other	Concentration of Osteopontin (ng/mL)	continuous measure in blood	Up to 48 Weeks
Other	Moderate to Severe OSA Non-Adherent to CPAP	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	Up to 10 years
Primary	Serum matrix metalloproteinase-7 (MMP-7, ng/mL)	The differences between-arm difference in the longitudinal changes of MMP-7 will be measured.	Up to 24 Weeks
Primary	Serum surfactant protein-D (SP-D, ng/mL)	The between-arm difference in the longitudinal changes of SP-D will be measured.	Up to 24 Weeks
Primary	Serum Angiopoietin-2 (Ang-2, ng/mL)	The between-arm difference in the longitudinal changes of Ang-2 will be measured.	Up to 48 Weeks
Primary	Serum surfactant protein-A (SP-A, ng/mL)	The between-arm difference in the longitudinal changes of SP-A will be measured.	Up to 24 weeks
Secondary	Forced vital capacity (FVC)	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.	24 and 48 weeks
Secondary	Diffusing capacity of the lung for carbon monoxide (DLCO)	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.	24 and 48 weeks
Secondary	Score on St. George's Respiratory Questionnaire (SGRQ)	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.	24 and 48 weeks
Secondary	Score on University of California San Diego (USCD) Shortness of Breath Questionnaire (SOBQ)	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.	24 and 48 weeks
Secondary	Score on Epworth Sleepiness Scale (ESS)	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'.	24 and 48 weeks
Secondary	Sleep Apnea Quality of Life Index (SAQLI)	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".	24 and 48 weeks
Secondary	Assess Quality of life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF)	ATAQ-IPF is a 74-item questionnaire used to assess quality of life among adults with idiopathic pulmonary fibrosis.	24 and 48 weeks
Secondary	Gastroesophageal Reflux Disease Questionnaire (GERD-Q)	GerdQ is a 6-item questionnaire to assess gastroesophageal reflux symptoms.	24 and 48 weeks
Secondary	Cough Visual Analog Scale	Cough visual analog scale, a standardized scale ranging from 0 (no cough) to 100 (severe cough) on a continuous scale.	24 and 48 weeks