Filter results

Clinical Studies

Contact Us for the Latest Status

Closed for Enrollment

  • A Phase I/II, Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic Fibrosis Rochester, Minn.

    This trial will consist of three arms: Part A, Part B, and Part C. Part A has two groups. The first group will enroll adult subjects with cystic fibrosis (CF) into a single ascending dose (SAD) treatment group. The second group will enroll adult subjects with CF, including those on background treatment with ORKAMBI® and those not on a cystic fibrosis transmembrane conductance regulator (CFTR) modulator, into a multiple ascending dose (MAD) treatment group. Part B will enroll adult subjects with CF currently on stable ORKAMBI® background therapy for a minimum of 3 months into a Phase II treatment group consisting of two cohorts. Part C will enroll adult subjects with CF, including those on background treatment with KALYDECO® and those not on a CFTR modulator, into a Phase II treatment group consisting of three cohorts. Approximately 136 subjects will be enrolled.

  • An Open-label, Non-controlled, Multicenter, Pilot Trial, Using Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) Infection (ENCORE) Rochester, Minn.

    The purpose of this study is to evaluate the effectiveness of inhaled molgramostim, administered open-label, to adult cystic fibrosis subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing antimycobacterial guideline based combination therapy.

  • Cystic Fibrosis Patient Registry Rochester, Minn.

    The goal of the Cystic Fibrosis (CF) Patient Registry, the ongoing data collection effort sponsored by the Cystic Fibrosis Foundation, is to collect data on individuals with Cystic Fibrosis (CF) or individuals with Cystic Fibrosis (CF) related disorders (e.g., CFTR-related metabolic syndrome (CRMS), CFTR-related disorders).

  • Cystic Fibrosis Patient Registry Rochester, Minn.

    The purpose of the Cystic Fibrosis Patient Registry is to gather and maintain data on all patients with the disease so that current and accurate data can be provided to researchers and clinicians regarding practice patterns, age and gender distributions, clinical outcomes, mortality and morbidity rates, and so that epidemiologic research can be performed.


       
  • GM-CSF and Cytokines in Cystic Fibrosis Airway Specimens Rochester, Minn.

    This study aims to assess GM-CSF and cytokine concentrations in sputum from cystic fibrosis patients. Correlation with pulmonary function will be determined and compared between persons colonized or non-colonized with non-tuberculous mycobacterium (NTM).

  • Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Rochester, Minn.

    The purpose of this study is to provide evidence of the safety and effectiveness of inhaled mannitol for adult patients with cystic fibrosis.

     

  • Surface Scanning Morphometry of Premature Infants using Photogammetry Rochester, Minn.

    The objective of this innovative project is to determine variance and rate of change in facial morphometry in neonates, ranging in weight from 400 grams up to babies weighing over 4 kg. If successful, the proposed developments will likely have far reaching consequences in other neonatal care applications such as custom-fit neonatal CPAP masks. 

.