Phase 1 Cystic Fibrosis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Lung function testing (spirometry) during screening shows FEV1 (a measure of how much air can be breathed out) at 40% or more of the expected value for a person of that age and size
• The person is able to correctly use the study inhaler device, as judged by the study doctor
• The person has been on a stable treatment plan for their lung condition for at least 28 days before starting the study, and is willing to stay on that same plan throughout the study
• The person's lung condition has been stable for at least 28 days before screening and up until the start of the study treatment

For one part of the study (Part B), additional criteria apply:

• The person produces at least one teaspoon of mucus/phlegm per day on average
• The person is able to produce a phlegm sample suitable for laboratory testing as part of research into disease markers
• A blood sample is available for the same type of research

For people with a condition called non-cystic fibrosis bronchiectasis (NCFB):

• A chest CT scan taken previously has confirmed bronchiectasis (widened airways) affecting at least two sections of the lungs, with at least one affected section in the right lung, as assessed by the study doctor

For people with chronic obstructive pulmonary disease (COPD):

• Breathing tests confirm a COPD diagnosis, specifically a post-bronchodilator FEV1/FVC ratio below 0.7 (confirm with trial site)
• The person has chronic bronchitis, meaning a long-term cough with excess mucus production for more than 3 months per year for at least 2 years before screening
• The person is a former smoker with at least a 10 pack-year smoking history (for example, one pack per day for 10 years), or a non-smoker with at least one documented risk factor for COPD

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant during the study or during any required contraception period after the study
• People with a known significant response to bronchodilator medicines that changes their lung function by more than 10%, as judged by the study doctor
• People currently taking any medications that are not allowed under the study rules
• People who have had an acute respiratory infection within 28 days before screening
• People who have coughed up more than 60 mL of blood at any one time in the 3 months before screening
• People with a known immune system deficiency that the study doctor considers significant and that greatly increases the risk of serious infections
• People with a known history of substance misuse within the 12 months before screening, as judged by the study doctor
• People with poor access to veins for blood draws
• People who have received blood products within 120 days before screening
• People with any medical condition or abnormal lab result that the study doctor believes would make participation unsafe, affect study completion, or affect how results are interpreted
• People with a history of chest cancer or cancer that has spread to other parts of the body within the 5 years before screening
• People with a known clinically significant heart rhythm abnormality on an ECG, or an abnormal ECG result considered significant by the study doctor
• People whose heart's QT interval (a measure of electrical activity in the heart) is above 450 milliseconds for males or above 470 milliseconds for females on an ECG reading

For Part B of the study, the following additional exclusion applies:

• People who have had more than 2 chest CT scans or other procedures that expose the lungs to more than 100 millisieverts of radiation in the 12 months before screening

For people with NCFB, additional exclusions apply:

• People whose bronchiectasis is mainly caused by cystic fibrosis, a condition affecting the tiny hair-like structures in the airways (primary ciliary dyskinesia), a specific type of bacterial lung infection (non-tuberculous mycobacterial infection), ongoing accidental inhalation of food or liquid (chronic aspiration), or scarring-related lung disease, as judged by the study doctor
• People whose primary respiratory condition is asthma, where the bronchiectasis finding is considered incidental by the study doctor
• People who have had an NCFB flare-up (worsening of symptoms) within 28 days before screening, or whose condition has not returned to its usual baseline level
• People who currently smoke, defined as any use of tobacco products or inhaled marijuana within 3 months before screening, including cigarettes, cigars, e-cigarettes, vaping devices, or pipes

For people with NCFB in a specific group (Cohort 3):

• People whose primary respiratory condition is COPD, where the bronchiectasis finding is considered incidental by the study doctor

For people with COPD, additional exclusions apply:

• People who have had a COPD flare-up within 28 days before screening, or whose condition has not returned to its usual baseline level
• People who have a condition considered to be a combination of both asthma and COPD (sometimes called asthma-COPD overlap syndrome)

Important: Always verify eligibility with the trial site directly before applying.