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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

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 below
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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:
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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.
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I am currently taking medication for heart conditions, infections, or pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed for five consecutive cardiac cycles and are measured in triplicate
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed for five consecutive cardiac cycles and are measured in triplicate for reporting.

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 more

Side effects data

From 2013 Phase 4 trial • 105 Patients • NCT00323297
14%
Diarrhoea
14%
Oedema peripheral
14%
Headache
10%
Flushing
10%
Bronchitis
10%
Nasopharyngitis
10%
Vertigo
10%
Palpitations
8%
Respiratory tract infection
6%
Depression
6%
Dyspnoea
6%
Right ventricular failure
6%
Vision blurred
6%
Presyncope
6%
Pulmonary hypertension
4%
Anaemia
4%
Pulmonary arterial hypertension
4%
Upper respiratory tract infection
4%
Bronchopneumonia
2%
Haemoglobin decreased
2%
Nausea
2%
Cardiac failure
2%
Cough
2%
Acute coronary syndrome
2%
Hypoxia
2%
Cardiovascular disorder
2%
Death
2%
Skin ulcer
2%
Back pain
2%
Haemoptysis
2%
Chest discomfort
2%
Walking distance test abnormal
2%
Coronary artery disease
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
937 Previous Clinical Trials
433,664 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,517,913 Total Patients Enrolled
Michael K Stickland, Ph.D.Principal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
64 Total Patients Enrolled

Media Library

Sildenafil Citrate (Phosphodiesterase-5 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05061368 — Phase 2
Chronic Obstructive Pulmonary Disease Research Study Groups: Sildenafil, Placebo
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Sildenafil Citrate Highlights & Side Effects. Trial Name: NCT05061368 — Phase 2
Sildenafil Citrate (Phosphodiesterase-5 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05061368 — Phase 2
~25 spots leftby Jun 2025
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