Status:

RECRUITING

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Lead Sponsor:

Novlead Inc.

Collaborating Sponsors:

The First Affiliated Hospital with Nanjing Medical University

Conditions:

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility:

All Genders

40-75 years

Phase:

NA

Brief Summary

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 deve...

Eligibility Criteria

Inclusion Criteria:

  1. Aged between 40 and 75 years, inclusive.
  2. History of smoking with a cumulative exposure of ≥10 pack-years, and having ceased smoking for at least one month prior to study participation.
  3. Diagnosis of moderate-to-severe COPD confirmed by post-bronchodilator spirometry: FEV1/FVC < 0.7 and FEV1 between 30% and 80% of predicted value.
  4. Willing and able to provide written informed consent and comply with all study-related procedures.

Exclusion Criteria:

  1. Pregnancy or lactation.
  2. Use of nicotine-containing products (e.g., patches, gum) within the past month.
  3. Current diagnosis of asthma or any other active respiratory condition considered non-COPD by the investigator.
  4. Physical obstruction of the nasal passages.
  5. Experienced a COPD exacerbation within the past month requiring initiation or escalation of systemic corticosteroids.
  6. Impaired left ventricular systolic function, defined as left ventricular ejection fraction (LVEF) < 50%.
  7. Significant valvular heart disease (moderate/severe aortic or mitral stenosis/regurgitation) or prior mitral valve replacement.
  8. Use of approved pulmonary hypertension medications (e.g., sildenafil, bosentan, prostacyclins) within 30 days prior to screening or during the study.
  9. Participation in another interventional clinical trial involving drugs or devices within 30 days prior to enrollment.
  10. Any other medical or psychiatric condition that, in the investigator's judgment, would compromise patient safety or study integrity.

Key Trial Info

Start Date :

May 17 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 30 2026

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT07382258

Start Date

May 17 2023

End Date

April 30 2026

Last Update

February 2 2026

Active Locations (1)

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The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China, 210000

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease | DecenTrialz