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Phosphodiesterase-5 Inhibitor
Oral Sildenafil for COPD
Phase 2
Recruiting
Led By Michael K Stickland, Ph.D.
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
COPD Free Controls will have: No diagnosis of COPD
Participants will have COPD as defined as: Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) below the lower limit of normal
Must not have
A diagnosis of pulmonary hypertension preceding COPD
Postmenopausal female participants must be amenorrheic for ≥12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 20-25 minutes post-dose
Awards & highlights
Summary
This trial will test whether sildenafil, an oral pulmonary vasodilator, can improve exercise tolerance and shortness of breath in mild COPD.
Who is the study for?
This trial is for adults with mild COPD who experience significant shortness of breath. Participants must have a specific lung function level (FEV1 >30% predicted) and can't be on certain medications or have heart conditions that limit exercise. Women able to bear children must use contraception, and postmenopausal women must be amenorrheic for at least 12 months.
What is being tested?
The study tests if Sildenafil, an oral medication that widens blood vessels in the lungs, can improve exercise capacity and reduce shortness of breath in people with mild COPD compared to a placebo (a pill without active medicine).
What are the potential side effects?
Sildenafil may cause headaches, flushing, indigestion, nasal congestion, dizziness, vision changes like blurring or color tingeing. It's important to note individual reactions can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never been diagnosed with COPD.
Select...
I have COPD, confirmed by a specific lung function test.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I was diagnosed with high blood pressure in my lungs before my lung disease.
Select...
I have not had a menstrual period for at least 12 months.
Select...
I am currently taking medication for heart conditions, infections, or pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed for five consecutive cardiac cycles and are measured in triplicate
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed for five consecutive cardiac cycles and are measured in triplicate
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Exercise Capacity
Secondary study objectives
Cardiac Output during exercise
Dyspnea
Pulmonary Artery Systolic Pressure
+1 moreSide effects data
From 2013 Phase 4 trial • 105 Patients • NCT0032329714%
Diarrhoea
14%
Oedema peripheral
14%
Headache
10%
Bronchitis
10%
Flushing
10%
Nasopharyngitis
10%
Vertigo
10%
Palpitations
8%
Respiratory tract infection
6%
Depression
6%
Right ventricular failure
6%
Dyspnoea
6%
Vision blurred
6%
Presyncope
6%
Pulmonary hypertension
4%
Pulmonary arterial hypertension
4%
Anaemia
4%
Upper respiratory tract infection
4%
Bronchopneumonia
2%
Nausea
2%
Haemoglobin decreased
2%
Cardiac failure
2%
Cardiovascular disorder
2%
Chest discomfort
2%
Haemoptysis
2%
Cough
2%
Acute coronary syndrome
2%
Hypoxia
2%
Death
2%
Coronary artery disease
2%
Skin ulcer
2%
Back pain
2%
Walking distance test abnormal
2%
Pancreatic neoplasm
2%
Breast cancer
2%
Uterine haemorrhage
2%
Mitral valve incompetence
2%
Inguinal hernia
2%
Circulatory collapse
2%
General physical health deterioration
2%
Urinary tract infection
2%
Asthenia
2%
Respiratory syncytial virus infection
2%
Gangrene
2%
Sinusitis
2%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sildenafil
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SildenafilExperimental Treatment1 Intervention
Participants will be administered a 25 mg oral dose of sildenafil.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be administered an oral placebo indistinguishable from the sildenafil pill.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sildenafil Citrate
2021
Completed Phase 4
~1590
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
919 Previous Clinical Trials
431,453 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,379 Previous Clinical Trials
26,513,852 Total Patients Enrolled
Michael K Stickland, Ph.D.Principal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
64 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using or willing to use birth control if I can have children.I have a heart condition that could affect my ability to do physical tests.Your FEV1 (a measure of lung function) is greater than 30% of what is expected for someone with severe COPD.Your lung function test shows that you have normal airflow in your lungs after using a bronchodilator.I was diagnosed with high blood pressure in my lungs before my lung disease.I have not had a menstrual period for at least 12 months.I have never been diagnosed with COPD.I am currently taking medication for heart conditions, infections, or pain.You are not able to do exercise testing or you have a bone or muscle condition that may limit your ability to do exercise testing.Your lung function is better than 80% of what is expected for someone your age and size.I have COPD, confirmed by a specific lung function test.
Research Study Groups:
This trial has the following groups:- Group 1: Sildenafil
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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