Comparison study of unsupervised remote and supervised clinic spirometry measurements in a clinical trial setting

SESSION TITLE: Pulmonary Physiology Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/10/2023 12:00 pm - 12:45 pm PURPOSE: The recent pandemic has renewed interest in the practice of remote monitoring for clinical trials and patient management. This raises the question of the role of app-based home spirometry for such purposes. However, there is a paucity of data to confirm that remote spirometry measurements can be used instead of clinic spirometry. Here we analyzed the data from a phase 2a clinical trial for a novel inhaled polycationic glycopolymer (SNSP113, Synspire Pharmaceuticals) utilizing both clinic and remote spirometry (NuvoAir Air Next device) METHODS: We utilized the data from this phase 2a study which had the goal of determining safety and performance of long-term (28-days) administration in a cystic fibrosis population. SNSP113 targets the cohesion and viscosity of biofilms, abnormal mucus, and bacteria at the pulmonary mucus interface. Adult cystic fibrosis patients from 7 sites in Europe received either SNSP113 0.1,0.5,1.0,1.5,2.0,2.5 mg or placebo once per day by nebulizer plus standard of care for 28 days. Patients were evaluated for safety and efficacy, including clinic and remote spirometry using the NuvoAir Air Next device. Clinic spirometry was measured at the screening visit, baseline, weeks 1,2,4, and 6; NuvoAir spirometry was measured during the screening period, baseline, and 3 times per week throughout the trial. By comparing spirometry data from the clinic to NuvoAir data recorded within ±1 day of the clinic measurement, we performed bioequivalence testing on FEV1 and FVC using the methods outlined in Statistical Approaches to Establishing Bioequivalence (fda.gov). We calculated the ratio of the values and the 90%CI, and deemed the values to be bioequivalent if the confidence intervals were within 80 to 120%. RESULTS: 65 adult cystic fibrosis patients were screened and 48 were randomized for treatment. Patients were between 18 and 44 years old, 44% were females, and median BMI was 21 (IQR:19-23). The median FEV1 % predicted at baseline was 64.8% (IQR:52.3% – 76.3%). Active and placebo were well tolerated. There were 196 matched sessions of clinic and NuvoAir spirometry measurements in the analysis. The test-to-reference ratio for FEV1 was 104.1% (90% CI:102.1% – 106.1%), for FVC was 108.3% (90% CI:105.1% - 111.5%). Both were well within the bioequivalence limits of 80 to 120%. In addition, the data from the clinic and NuvoAir measurement showed a close correlation (Pearson r for FEV1 is 0.92 and FVC is 0.83). CONCLUSIONS: This analysis shows bioequivalence using the FDA standard for spirometry assessed in the supervised setting in the clinic and in the unsupervised setting using NuvoAir Air Next remotely, also, our results provide quantification of accuracy of remote spirometry for clinical use. CLINICAL IMPLICATIONS: The desire to reduce the number of in person clinic visits for patient management and clinical trial outcome assessment has led to the consideration of utilizing app-based systems such as NuvoAir. The demonstration that the data from such systems used by the patients remotely give bioequivalent data to clinic measurement supports its use thereby benefiting patients and health care providers. DISCLOSURES: Consultant relationship with nuvoair Please note: 2022-2023 Added 03/31/2023 by Richard FULLER, source=Web Response, value=Consulting fee No relevant relationships by Danielle Gallotto No relevant relationships by Robert Gallotto Employee relationship with NuvoAir U.S. Inc Please note: 10/18/2021-Present Added 04/07/2023 by Dandi Qiao, source=Web Response, value=Salary No relevant relationships by Furat Shawki Employee relationship with Synspira Therapeutics Please note: 03/01/23 - 4/7/23 Added 04/07/2023 by Hugh Wight, source=Web Response, value=Salary