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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 20-25 minutes post-dose
Awards & highlights
Study 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.Check my eligibility
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).See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Exercise Capacity
Secondary outcome measures
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%
Vertigo
10%
Bronchitis
10%
Flushing
10%
Palpitations
10%
Nasopharyngitis
8%
Respiratory tract infection
6%
Pulmonary hypertension
6%
Depression
6%
Presyncope
6%
Dyspnoea
6%
Right ventricular failure
6%
Vision blurred
4%
Pulmonary arterial hypertension
4%
Upper respiratory tract infection
4%
Bronchopneumonia
4%
Anaemia
2%
Hypertension
2%
Cough
2%
Acute coronary syndrome
2%
Inguinal hernia
2%
Asthenia
2%
Cardiovascular disorder
2%
Mitral valve incompetence
2%
Gangrene
2%
Respiratory syncytial virus infection
2%
Urinary tract infection
2%
Walking distance test abnormal
2%
Breast cancer
2%
Uterine haemorrhage
2%
Haemoptysis
2%
Hypoxia
2%
Skin ulcer
2%
Nausea
2%
Back pain
2%
Death
2%
General physical health deterioration
2%
Circulatory collapse
2%
Cardiac failure
2%
Coronary artery disease
2%
Chest discomfort
2%
Pancreatic neoplasm
2%
Haemoglobin decreased
2%
Sinusitis
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
889 Previous Clinical Trials
384,974 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,607 Total Patients Enrolled
Michael K Stickland, Ph.D.Principal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
87 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions is Sildenafil Citrate used to treat?
"Sildenafil Citrate can be used to effectively manage premature ejaculation, as well as nyha functional class ii-iii pulmonary arterial hypertension and regular pulmonary arterial hypertension."
Answered by AI
Are we still enrolling individuals for this experiment?
"That is correct, the online information indicates that the trial is still enrolling patients. The posting date was March 1st, 2022 and the most recent update was on September 19th, 2022. They are hoping to recruit 160 individuals from a single location."
Answered by AI
Are there any limits to how many people can join this trial?
"Yes, that is accurate. If you visit clinicaltrials.gov, you will see that this trial was first posted on 3/1/2022 and is presently looking for 160 individuals to participate at 1 location."
Answered by AI
Is this research only being conducted with adults over the age of 25?
"This trial is only open to patients that are between 40-80 years old."
Answered by AI
What are the potential dangers associated with Sildenafil Citrate?
"While Phase 2 trials offer preliminary evidence of a drug's safety, there is no data yet supporting efficacy. For these reasons, our team has given Sildenafil Citrate a score of 2."
Answered by AI
Which type of patient would be a ideal candidate for this clinical research?
"Patients with lung disorders who are between 40 and 80 years old may be eligible for this clinical trial. The research is hoping to enroll a total of 160 individuals."
Answered by AI
Recent research and studies
New England Journal of MedicineJournal
Sildenafil Citrate Therapy for Pulmonary Arterial HypertensionOther Trials to Consider
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