Quality Awards
Clinical Trials
Parallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade E, Stages II-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 30 years or greater
4. FEV1/FVC of < 70% and an FEV1 of < 80% (GOLD stages II – IV, Grade E)
∙ Spirometry performed during the screening visit will be used to confirm GOLD stage. A prior spirometric test within the past 6 months can be substituted if available.
5. MRC ≥ 2 or CAT ≥ 10
6. Former smokers or current smokers and never-smokers are eligible for study inclusion
∙ Current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device
7. History of a severe COPD exacerbation requiring hospitalization in the previous six weeks
8. COPD in a stable state after hospitalization defined as:
∙ Clinically stable condition and have had no parenteral therapy for 24 hours.
∙ Inhaled bronchodilators are required less than four-hourly.
∙ Oxygen delivery has ceased for 24 hours (unless home oxygen is indicated).
∙ If previously able, the patient is ambulating safely and independently, and performing activities of daily living.
∙ The patient can eat and sleep without significant episodes of dyspnea.
∙ The patient or caregiver understands and can administer medications.
∙ Follow-up and home care arrangements (e.g., home oxygen, homecare, Meals on Wheels, community nurse, allied health, GP, specialist) have been completed.
9. Willing to adhere to the daily use of the myAirvo 3 regimen for at least 8 hours each day preferably at night following being shown and using the device
10. Willing to record daily symptoms and pulse oximetry and heart rate on daily basis
11. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
Highly effective contraception is defined as:
∙ A tubal ligation:
∙ An approved hormonal contraceptive such as oral contraceptives, emergency contraception used as directed, patches, implants, injections, rings or intrauterine devices
12. Able to read and communicate in English
13. Have a home environment suitable for myAirvo 3 use.
14. Agreement to adhere to Lifestyle Considerations throughout study duration – refraining from smoking while receiving supplemental oxygen or the myAirvo-3 device.
Study Coordinator
Monica Hosler, CRC
email:
Monica.Hosler@sluhn.org
To prospectively evaluate screening strategies for pulmonary hypertension (PH) in patients with ILD in an effort to promote awareness and encourage screening for PH in this patient population.
Patients are eligible to be included in the study only if all the following criteria apply:
1. Males and females at least 18 years of age who give voluntary written informed consent to participate in the study.
2. Patients with a diagnosis of ILD based on computed tomography imaging, including:
a. Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis
b. Connective tissue disease-associated ILD with FVC <70%
c. Hypersensitivity pneumonitis
d. Scleroderma-related ILD
e. Autoimmune ILD
f. Nonspecific interstitial pneumonia
g. Occupational lung disease
h. Combined pulmonary fibrosis and emphysema
3. Patients must meet a total of 2 or more criteria from at least 2 distinct categories below (ie, Category 1, Category 2, Category 3) based on the Investigator's clinical judgment, within 180 days of Screening. For example, a patient could qualify by meeting Category I-Criterion b (HRCT with any of the findings listed) and Category 2-Criterion a (symptoms disproportionate to ILD severity).
Category 1: Clinical tests
· PFTs with at least 1 of the following results:
· DLCO <40%
· DLCO decline of 2:'.:15% based on 2 most recent assessments
· Worsening DLCO (decline >10%) with stable FVC (decline <5%) (ie, worsening FVC/DLCO ratio) based on 2 most recent assessments
b. Historical HRCT with any of the following findings:
· RV enlargement: RV:LV ratio >1
· Pulmonary artery enlargement
· Pulmonary artery/aorta ratio > 1.0
· Ventricular septal flattening
· Enlarged pulmonary arteries in the lung periphery
Category 2: Symptoms, oxygenation, exercise capacity, and BNP/NT-proBNP
a. Symptoms disproportionate to ILD severity or changes in symptoms not explained by ILD progression
b. Desaturation on 6MWT disproportionate to ILD severity in the opinion of the Investigator
c. 6-Minute Walk Distance decline of 2:'.:15% based on 2 more recent assessments
d. Worsening desaturation requiring more supplemental oxygen
e. Recent worsening desaturation
f. BNP >200 pg/mL orNT-proBNP >395 pg/mL
g. Physical exam findings (at least 1 of the following): syncope, jugular venous distension, ankle swelling/peripheral edema, ascites, loud P2 or S2 heart sound, or hepatomegaly
Category 3: Echocardiography
a. RV systolic pressure >35 mmHg
b. Any RV dilation or enlargement
c. Other RV abnormalities in the clinician's judgement
d. Tricuspid annular plane systolic excursion <2 cm
If a patient does not have a historical PFT, HRCT, or echocardiogram needed to assess eligibility for the study, these procedures will be performed as part of study screening. In order to be eligible for RHC, patients must meet a total of 2 or more criteria from at least 2 distinct categories above (ie, Category 1, Category 2, Category 3).
The purpose of the study is to learn more about dupilumab (the study drug) when given over a longer duration (3 years) in patients with moderate to severe asthma that is not well controlled.
- At least 18
- Patients with a physician diagnosis of asthma (according to Global Initiative for Asthma (GINA) 2021) for ≥12 months
- Treatment with medium to high dose inhaled corticosteroids (ICS) (≥250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta-2 adrenergic receptor agonists (LABA), LTRA) with a stable dose ≥1 month
To evaluate the safety and tolerability of oral daily administration of TTI-101 over a 12-week treatment duration in participants with IPF.
The participant and the treating physician should have considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study. Participants must meet all the following criteria to be eligible:
1. Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions.
2. ≥ 40 years at the time of informed consent.
3. Diagnosed with IPF based on either the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) International Diagnostic Guidelines or on the 2022 updated Guidelines within 5 years prior to the date of informed consent. If a lung biopsy was required to make the diagnosis of IPF per the 2018 or 2022 ATS/ERS/JRS/ALAT International Diagnostic Guidelines, then that biopsy must have been a surgical lung biopsy or a transbronchial lung cryobiopsy and performed within 5 years of screening in order to fulfill inclusion criteria #3.
4. Chest HRCT performed within 12 months prior to providing informed consent meeting requirements for IPF diagnosis based on the 2018 or 2022 ATS/ERS/JRS/ALAT guidelines and confirmed by central review. If a subject did not have a chest HRCT that was performed within 12 months of informed consent, then they will be required to have a chest HRCT performed during screening for central review. If the HRCT pattern demonstrates a Usual Interstitial Pneumonia (UIP) or probable UIP pattern by central read, the PI’s diagnosis of IPF in the appropriate clinical context is sufficient without a lung biopsy. If the HRCT pattern is indeterminant for UIP or consistent with an alternative diagnosis, then a historical surgical lung biopsy or transbronchial lung cryobiopsy demonstrating UIP on histopathology is required to confirm the diagnosis of IPF in the appropriate clinical context.
5. The total extent of fibrotic changes are greater than the extent of emphysematous changes on the HRCT being utilized for IPF diagnosis confirmation.
6. Greater than 45% of predicted forced vital capacity (FVC) and a ratio of forced expiratory volume in 1 second (FEV1)/(FVC ≥0.7 measured pre-bronchodilator during screening confirmed by central review.
7. A predicted diffusing capacity of the lungs for carbon monoxide (DLCO) (hemoglobin [Hb] corrected) >30% during screening confirmed by central review.
8. Oxygen saturation (SpO2) ≥ 88% with up to 2L O2/min by pulse oximetry at rest.
9. If currently receiving nintedanib, dose must have been stable for ≥3 months prior to randomization. If participant has previously discontinued nintedanib, there is a 6-week washout period required before screening can begin.
10. Has a life expectancy of at least 12 months.
11. Able to comply with the requirements of the study protocol, according to the investigator’s best judgment.
12. Females of childbearing potential (ie, ovulating, premenopausal, and not surgically sterile) must:
- Have a negative serum pregnancy test at screening.
- Not be breastfeeding or lactating.
- Agree to use a highly effective method of birth control for the duration of the study and for at least 30 days after the last dose in the study. Effective forms of birth control include barrier methods used in conjunction with a spermicidal agent (according to standard local practices), nonhormonal intrauterine devices, or permanent sterilization.
13. Males must:
- Agree to use a condom for at least 30 days after the last dose in the study even if vasectomized in order to prevent delivery of the drug via seminal fluid.
- Agree to abstain from sperm donation through 30 days after administration of the last dose of IP.
- Unless surgically sterile, males with female partners of childbearing potential must agree to use 2 methods of acceptable birth control for at least 30 days after the last dose in the study. Effective forms of birth control include barrier methods used in conjunction with a spermicidal agent (according to standard local practices), nonhormonal intrauterine devices in female partners, or permanent sterilization.
