The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in Interstitial Lung Disease.

NCT04181359 | Withdrawn Phase 1

• 1 other identifier: Pro00092702
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Interstitial Lung Disease (ILD) is a is a lung disorder which makes breathing more difficult. During exercise, patients with ILD are not efficient breathers and this leads to serious breathing difficulties, which often causes these patients to stop exercise at low intensities. The investigators think that these patients with ILD 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 mild ILD patients, and find out whether improving lung blood vessel function helps ILD 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 ILD patients.

Conditions

Dyspnea

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  Exercise capacity as determined by peak power output and oxygen uptake (V̇O2peak).

  Within 20-25 minutes post-dose

Secondary Outcomes (3)

• Ventilation

  Within 20-25 minutes post-dose

• Perceived breathing discomfort (Modified Borg 0-10 categorical ratio scale)

  Within 20-25 minutes post-dose

• Pulmonary vascular function

  Within 5 minutes post-dose

Study Arms (2)

Nitric Oxide

EXPERIMENTAL

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

Drug: Nitric Oxide

Placebo

PLACEBO COMPARATOR

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

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: iNO

Nitric Oxide

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ILD participants free of any significant cardiovascular, metabolic or neuromuscular disease. Specific criteria are:
• Established physician diagnosis of ILD
• Forced vital capacity 50-80 % predicted
• Diffusing capacity for carbon monoxide 35-60 % predicted
• Able to complete a 6-minute walk test
• Participants will range from 18-85 years old.
• There are no restrictions on pulmonary medications, however, participants will be asked to withdraw from long-acting beta agonists 48 hours prior to trials.

You may not qualify if:

• Participants with current or previous history of myocardial infarction or angina pectoris will be excluded.
• Participants with a lowest arterial oxygen saturation \< 84% during the initial CPET (day 1) on room air will be excluded.
• Patient receiving treatment for isosorbide mononitrate or pulmonary arterial hypertension (PAH) medications will be excluded.

Sponsors & Collaborators

• University of Alberta: lead

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

• Giovanni Ferrara, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Michael Stickland, PhD

  University of Alberta

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 29, 2019
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share