A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorNovlead Inc.
About this trial
This clinical trial aims to assess the impact on exercise tolerance and the safety of inhaled nitric oxide in subjects with moderate-to-severe COPD. The findings are expected to contribute to the development of safe and effective therapeutic strategies for COPD management.
Eligibility criteria
Qualifiers
Aged between 40 and 75 years, inclusive.
History of smoking with a cumulative exposure of ≥10 pack-years, and having ceased smoking for at least one month prior to study participation.
Diagnosis of moderate-to-severe COPD confirmed by post-bronchodilator spirometry: FEV1/FVC < 0.7 and FEV1 between 30% and 80% of predicted value.
Willing and able to provide written informed consent and comply with all study-related procedures.
Disqualifiers
Pregnancy or lactation.
Use of nicotine-containing products (e.g., patches, gum) within the past month.
Current diagnosis of asthma or any other active respiratory condition considered non-COPD by the investigator.
Physical obstruction of the nasal passages.
Trial design
Treatments tested in this trial
- Nitric Oxide Generation and Delivery System
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
Novlead Inc.
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Source ClinicalTrials.gov