The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in COPD

NCT03679312 | Completed Phase 1

• 1 other identifier: Pro00078715
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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 patients 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 patients with 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

Dyspnea

Outcome Measures

Primary Outcomes (2)

• Peak Workload

  Peak workload will be defined as the highest wattage obtained during a 20 s period during the test.

  Within 20-25 minutes post-dose

• Peak Oxygen Consumption

  Peak oxygen consumption will be defined as the highest O2 uptake (reported in ml/kg/min) obtained during a 20 s period during the test.

  Within 20-25 minutes post-dose

Secondary Outcomes (3)

• Dyspnea (breathlessness)

  Assessed every 2-minutes until completion of the exercise trial; anticipating ~10-14 minute tests

• Pulmonary artery systolic pressure

  Assessed for five consecutive cardiac cycles and are measured in triplicate during the cardiac ultrasound trial. This will be completed within 4 weeks of enrollment in the study.

• Emphysema severity score

  Emphysema severity score assessed by computed tomography. This will be completed within 4 weeks of enrollment in the study.

Study Arms (2)

COPD Group

EXPERIMENTAL

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

Drug: Nitric Oxide; Drug: Placebo

Control Group

EXPERIMENTAL

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

Drug: Nitric Oxide; Drug: Placebo

Interventions

Nitric Oxide DRUG

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

Also known as: Inhaled Nitric Oxide

COPD Group; Control Group

Placebo DRUG

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

Also known as: Medical Grade Room Air

COPD Group; Control Group

Eligibility Criteria

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

You may qualify if:

• No significant cardiovascular disease.
• No significant metabolic disease
• No significant neuromuscular disease
• Participants will range from 18-85 years old
• Age- and sex-matched to COPD patients
• Normal lung function
• Minimal smoking history
• 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
• Individual with musculoskeletal injuries
• Individuals currently on oral steroids (i.e. prednisone), phosphodiesterase type 5 (PDE5) inhibitors or supplemental O2 therapy

Sponsors & Collaborators

• University of Alberta: lead
• University Hospital Foundation: collaborator
• Canadian Lung Association: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Clinical Sciences Building

Edmonton, Alberta, t5r2j3, Canada

Location

MeSH Terms

Conditions

Dyspnea

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Michael K Stickland, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized double-blind cross-over design

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 20, 2018
• Study Start: September 4, 2018
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)