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New treatment option for Chronic Obstructive Pulmonary Disease
Official title A Clinical Study of Inhaled Nitric Oxide in Moderate-to-Severe Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT05896800
What this study is testing
- What it's testing
- The purpose of this study is to evaluate the influence of exercise capacity and safety of iNO at doses of 10 ppm or 40 ppm for 2 hours per day after continuous treatment for one week, which is of great significance for finding safe and effective methods for treating COPD.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- Age ≥ 40 years, ≤ 75 years;
- Previous smoking history ≥ 10 pack-years, and had stopped smoking for one month before study entry;
- Met the diagnosis criteria of moderate and severe COPD: a post-bronchodilator FEV1/FVC \< 0.7, and 30%\< FEV1 \< 80% predicted;
- Signed informed consent and performed all the study mandated procedures.
You likely can't join if
- Pregnant or lactating women;
- Current or recent month user of nicotine-like substances (including nicotine patches, etc.);
- A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator;
- Lack of patency of nares upon physical examination;
- Experienced during the last month an exacerbation requiring start of or increase in systemic oral corticosteroid therapy;
- Left ventricular systolic dysfunction: left ventricular ejection fraction (LVEF) \< 50%;
See the full eligibility criteria
- Age ≥ 40 years, ≤ 75 years;
- Previous smoking history ≥ 10 pack-years, and had stopped smoking for one month before study entry;
- Met the diagnosis criteria of moderate and severe COPD: a post-bronchodilator FEV1/FVC \< 0.7, and 30%\< FEV1 \< 80% predicted;
- Signed informed consent and performed all the study mandated procedures.
- Pregnant or lactating women;
- Current or recent month user of nicotine-like substances (including nicotine patches, etc.);
- A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator;
- Lack of patency of nares upon physical examination;
- Experienced during the last month an exacerbation requiring start of or increase in systemic oral corticosteroid therapy;
- Left ventricular systolic dysfunction: left ventricular ejection fraction (LVEF) \< 50%;
- Clinically significant valvular heart disease, including aortic valvular disease (moderate or severe aortic stenosis or regurgitation) and/or mitral valve disease (moderate or severe mitral stenosis or regurgitation)...
- Use within 30 days of screening or current use of approved pulmonary hypertension medications such as sildenafil, bosentan or prostacyclines;
- Use of investigational drugs or devices within 30 days prior to enrollment into the study;
- Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.