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

NCT04231760 | Not Yet Recruiting Phase 1

• 1 other identifier: Pro00092368
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Ventilation-perfusion matching

  Using the multiple inert gas elimination technique, ventilation-perfusion matching at rest and during exercise will be quantified by the second moment perfusion distribution (log standard deviation of the perfusion distribution (log SDQ)).

  Within 20-25 minutes post-dose

Secondary Outcomes (1)

• Ventilation

  Within 20-25 minutes post-dose

Study Arms (2)

Chronic Obstructive Pulmonary Disease

EXPERIMENTAL

Mild \& Moderate COPD to receive either placebo or inhaled nitric oxide (40ppm)

Drug: Inhaled Nitric Oxide; Drug: Placebo

Healthy Controls

ACTIVE COMPARATOR

Control group to receive either placebo or inhaled nitric oxide (40ppm)

Drug: Inhaled Nitric Oxide; Drug: Placebo

Interventions

Inhaled Nitric Oxide DRUG

Inhaled nitric oxide, which consists of breathing medical grade air (21% O2) with 40 parts per million of nitric oxide.

Chronic Obstructive Pulmonary Disease; Healthy Controls

Placebo DRUG

Inhaled placebo, which consists of breathing medical grade air (21% O2).

Chronic Obstructive Pulmonary Disease; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Stickland, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Desi Fuhr, MSc

CONTACT

780-492-8027; fuhr@ualberta.ca

Andrew Brotto, MSc

CONTACT

780-492-8027; abrotto@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share