Phase 1 COPD 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:

This trial has two phases, each open to different groups of people.

Phase 1 – Healthy adults:

• Adults aged 18 or older who are in good health, with normal lung function test (spirometry) results and no history of chronic cough or other breathing conditions.

Phase 2 – Adults with chronic cough or mild asthma (two separate groups):

• Adults aged 18 or older who have had a refractory or unexplained chronic cough for more than one year, with a normal chest X-ray and no airflow blockage detected on lung function testing, where the cough has either not improved enough despite treatment of any known contributing conditions, or where no underlying cause has been found after thorough investigation.
• Adults aged 18 or older with mild asthma who have not used steroid-based medicines for it, who test positive on a specific airway sensitivity test (called a methacholine challenge), whose symptoms of cough, breathlessness, chest tightness, and wheeze are considered well-controlled by the trial doctor, and who have not used inhaled or oral steroid medicines in the past month.

Who may not be able to join:

Phase 1 – Healthy adults:

• People who currently smoke or used to smoke heavily (more than 5 pack-years) and stopped less than 6 months ago.
• People who are unable to perform a reliable and repeatable lung function test (spirometry).
• People who have had an unresolved upper respiratory tract infection (such as a cold) within the 6 weeks before their first study visit.
• People who have had a lower respiratory tract infection or pneumonia within the 6 weeks before their first study visit.
• People who have certain serious lung conditions, including pulmonary embolism, pulmonary hypertension, lung cancer, cystic fibrosis, emphysema confirmed by imaging, severe bronchiectasis, or severe interstitial lung disease.
• People with a history of psychiatric illness, or drug or alcohol misuse that could affect their ability to take part.
• People with a significant heart or blood vessel condition, such as coronary artery disease, aortic aneurysm, or stroke within the last 3 months.
• People with serious medical conditions or who are not on a stable medication routine for their condition(s).
• People with immune system disorders, severe allergies, or who are currently on allergy immunotherapy.
• People who are pregnant or breastfeeding.
• Women who are able to become pregnant and do not agree to use an approved form of contraception for the full duration of the study (hormonal contraception must have been in use for at least 3 months before joining) — acceptable methods include the pill, patch, vaginal ring, injectable contraceptives, implant, double-barrier method, intrauterine device, or a partner who has had a vasectomy at least 6 months prior to screening (confirm with trial site for full details on contraception requirements).
• Anyone the trial doctor considers unable to safely or reliably complete the study.

Phase 2 – Chronic cough group:

• People who currently smoke, or who used to smoke heavily (20 or more pack-years) and stopped less than 6 months ago.
• People who meet any of the general exclusion criteria listed above for Phase 1 (spirometry, infections, lung conditions, heart conditions, immune disorders, pregnancy, contraception requirements, and others listed above).

Phase 2 – Mild asthma group:

• People who currently smoke, or who used to smoke heavily (20 or more pack-years) and stopped less than 6 months ago.
• People who have had an asthma flare-up or uncontrolled symptoms in the month before their first study visit.
• People who have used inhaled or oral steroid medicines in the month before their first study visit.
• People who meet any of the general exclusion criteria listed above for Phase 1.

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