Clinical trial

The Effect of Inhaled Nitric Oxide on Pulmonary Gas-exchange in COPD

Name
Pro00092368
Description
Chronic Obstructive Pulmonary Disease (COPD) is a lung disorder commonly caused by smoking, which makes breathing more difficult. When COPD patients exercise, they are not efficient breathers and this leads to serious breathing difficulties, which often causes these patients to stop exercise at low intensities. Even though patients with a mild form of COPD have relatively well preserved lung function, they still have inefficient breathing during exercise. The investigators think that these individuals have problems exchanging fresh gas (i.e., oxygen) into the blood stream because of poor lung blood vessel function. The investigators will test whether inhaled medications, specifically nitric oxide, can improve lung blood vessel function and decrease breathing difficulties during exercise. With this research, the investigators will understand more about breathing efficiency and lung blood vessel function in individuals with mild COPD, and find out whether improving lung blood vessel function helps COPD patients breathe easier and exercise longer. Understanding the reasons behind the feeling of difficult breathing may lead to more effective therapy and improved quality of life in COPD patients.
Trial arms
Trial start
2024-12-01
Estimated PCD
2025-12-01
Trial end
2026-02-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Inhaled Nitric Oxide
Inhaled nitric oxide, which consists of breathing medical grade air (21% O2) with 40 parts per million of nitric oxide.
Arms:
Chronic Obstructive Pulmonary Disease, Healthy Controls
Placebo
Inhaled placebo, which consists of breathing medical grade air (21% O2).
Arms:
Chronic Obstructive Pulmonary Disease, Healthy Controls
Size
80
Primary endpoint
Ventilation-perfusion matching
Within 20-25 minutes post-dose
Eligibility criteria
Inclusion Criteria: * Twenty participants with mild COPD (forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) below the lower limit of normal (\<-1.64 z-score)1) and FEV1 ≥ 80% predicted, with a smoking history (10 \> pack-years) will be recruited. Twenty participants with moderate COPD (FEV1/ FVC below the lower limit of normal (\<-1.64 z-score)1) and FEV1 50-80% predicted, with a smoking history (10 \> pack-years) will also be recruited. Additionally, 40 healthy individuals with be recruited. * Participants will be free of any known significant cardiovascular, metabolic or neuromuscular disease. Participants with COPD will have global initiative for chronic obstructive lung disease (GOLD) Stage 1 mild COPD (FEV1/FVC ratio \<0.70 and FEV1 ≥ 80% predicted1) and Stage 2 moderate COPD (FEV1/FVC ratio \<0.70 and FEV1 50-80% predicted) and a \>10 pack-year smoking history. Controls will have normal lung function, minimal smoking history and no previous diagnosis of COPD. Participants will range from 18-85 years old. Exclusion Criteria: * Individuals with significant cardiovascular, metabolic, neuromuscular or any other disease that could contribute to dyspnea or abnormal cardiopulmonary responses to exercise will be excluded. * Individuals with musculoskeletal injuries that prevent them from completing cycle ergometry exercise trials will be excluded. * COPD participants currently on oral steroids (i.e. prednisone), phosphodiesterase type 5 (PDE5) inhibitors or supplemental O2 therapy will be excluded.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-05-08

1 organization

1 product

1 drug

1 indication