Chronic Obstructive Pulmonary DiseasePhase 4NCT01382368
Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients
A Phase 4 study testing Sildenafil in people with Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Pulmonary diseases are increasingly important causes of morbidity and mortality in the modern world. Sildenafil, an orally administered a phosphodiesterase type 5 (PDE-5) inhibitor, targets the nitric oxide (NO) pathway. The drug was first approved for the treatment of Pulmonary Arterial Hypertension (PAH) in 2005. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2011to Sep 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with severe COPD GOLD stage III- IV, FEV1 30-50% or less of predicted values, greater shortness of breath, reduced exercise capacity, repeated excretions and\ or with chronic respiratory failure [9, 39].
- IPF patients diagnosed essentially according to the American Thoracic and European Respiratory Societies (ATS-ERS) by clinical diagnostic criteria of: (a) High-resolution computed tomography (HRCT) demonstrating a pattern of "confident" or "possible" IPF (b) Abnormal pulmonary physiology with evidence of restriction and/or impaired gas exchange (can exist during exercise alone) (c) Exclusion of other known causes of interstitial lung disease (e.g.: connective tissue disease, environmental exposure,etc.)[31].
- Patients post Pneumonectomy more than 6 month from the amputation surgery for any diagnosis (Cancer, Trauma, and Infection- Bronchiectasis).
Who cannot join
- Patients with known sensitivity or contraindications to phosphodiesterase 5 (PDE-5) inhibitor therapies will be excluding from the study.
- Thromboembolic disease will be excluded by pulmonary CT-angiography or perfusion scan.
- Patients with a history of left-sided heart failure will be excluded.
- Patients will also exclude if they are on regular treatment with nitrates or PDE-5 inhibitors (Sildenafil, Tadalafil, Vardenafil).
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pulmonary Institute, Rabin Medical Center, Beilinson Hospital
Petah Tikva, 49100
About this study
- Pulmonary diseases are increasingly important causes of morbidity and mortality in the modern world.
- Sildenafil, an orally administered a phosphodiesterase type 5 (PDE-5) inhibitor, targets the nitric oxide (NO) pathway. The drug was first approved for the treatment of Pulmonary Arterial Hypertension (PAH) in 2005.
- The aim of the suggested study is to examine the acute effect of oral intake of sildenafil on exercise tolerance and functional capacity in Chronic Obstructive Pulmonary Disease (COPD), Idiopathic pulmonary fibrosis (IPF) and post Pneumonectomy patients.
- The investigators hypothesize that oral ingestion of sildenafil prior the exercise may enhance exercise tolerance and improve function in COPD, IPF and post Pneumonectomy patients.
- Patients and Methods:
Sixty chronic lung disease patients males and females (aged 30 to 90 years) 20 COPD (GOLD III-IV) [9, 39] , 20 IPF and 20 post Pneumonectomy patients will be recruit to this study.
- All subjects will carried out two maximal cardiopulmonary exercise tests (CPET) on bicycle ergometer in different days; 60 min after intake of placebo and 60 min after intake of 100 mg sildenafil (Pfizer, Sandwich, UK), in random order.
- In first meeting prior exercise test at rest standard pulmonary function test, diffusion of CO, TLC and RV will be measured. In addition, Doppler Echocardiography and blood samples for NT-proBNP will be taken prior and post each CPET.
- After 15-20 minute of passive recovery post exercise test all patients will perform 3 short functional tests including 6 minute walk test to assess functional capacity.
- Being tested
- Sildenafil
- Keywords
- Post Pneumonectomy Patients, IPF, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Acute single dose of 100 mg of sildenafil. Oral intake in tablet form.
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | Not described Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 Peak
Measured: 2-30 days between exercise tests
6 min walk test
Distance walked in 6 min test
Measured: 2-30 days between exercise tests
Functional Tests
- 30 seconds chair stand test- number of repetitions in 30 sec
- 8-ft-up-and -go (agility and coordination)- number of sec that takes to complete the task.
Measured: 2-30 days between exercise tests
Secondary outcomes (2)
Pulmonary Arterial Pressure
Measured: 2-30 days between exercise tests
NT-pro-BNP
Measured: 2-30 days between exercise tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2012 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mordechai Kremer, Rabin Medical Center
- Investigators
- Mordechai R Kramer, M.D, Principal investigator, Rabin Medical Center, Belinson Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382368
- Sponsor's protocol ID
- RMCBH116278 CTIL
- Status last verified
- Nov 2012
- First submitted
- 2 May 2011
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients
- ClinicalTrials.gov ID
- NCT01382368
- Acronym / sponsor ID
- RMCBH116278 CTIL
- Keywords
- Post Pneumonectomy Patients, IPF, COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Pulmonary diseases are increasingly important causes of morbidity and mortality in the modern world.
- Sildenafil, an orally administered a phosphodiesterase type 5 (PDE-5) inhibitor, targets the nitric oxide (NO) pathway. The drug was first approved for the treatment of Pulmonary Arterial Hypertension (PAH) in 2005.
- The aim of the suggested study is to examine the acute effect of oral intake of sildenafil on exercise tolerance and functional capacity in Chronic Obstructive Pulmonary Disease (COPD), Idiopathic pulmonary fibrosis (IPF) and post Pneumonectomy patients.
- The investigators hypothesize that oral ingestion of sildenafil prior the exercise may enhance exercise tolerance and improve function in COPD, IPF and post Pneumonectomy patients.
- Patients and Methods:
Sixty chronic lung disease patients males and females (aged 30 to 90 years) 20 COPD (GOLD III-IV) [9, 39] , 20 IPF and 20 post Pneumonectomy patients will be recruit to this study.
- All subjects will carried out two maximal cardiopulmonary exercise tests (CPET) on bicycle ergometer in different days; 60 min after intake of placebo and 60 min after intake of 100 mg sildenafil (Pfizer, Sandwich, UK), in random order.
- In first meeting prior exercise test at rest standard pulmonary function test, diffusion of CO, TLC and RV will be measured. In addition, Doppler Echocardiography and blood samples for NT-proBNP will be taken prior and post each CPET.
- After 15-20 minute of passive recovery post exercise test all patients will perform 3 short functional tests including 6 minute walk test to assess functional capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: Sildenafil |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with severe COPD GOLD stage III- IV, FEV1 30-50% or less of predicted values, greater shortness of breath, reduced exercise capacity, repeated excretions and\ or with chronic respiratory failure [9, 39].
- IPF patients diagnosed essentially according to the American Thoracic and European Respiratory Societies (ATS-ERS) by clinical diagnostic criteria of: (a) High-resolution computed tomography (HRCT) demonstrating a pattern of "confident" or "possible" IPF (b) Abnormal pulmonary physiology with evidence of restriction and/or impaired gas exchange (can exist during exercise alone) (c) Exclusion of other known causes of interstitial lung disease (e.g.: connective tissue disease, environmental exposure,etc.)[31].
- Patients post Pneumonectomy more than 6 month from the amputation surgery for any diagnosis (Cancer, Trauma, and Infection- Bronchiectasis).
Key exclusion criteria (4 listed)
- Patients with known sensitivity or contraindications to phosphodiesterase 5 (PDE-5) inhibitor therapies will be excluding from the study.
- Thromboembolic disease will be excluded by pulmonary CT-angiography or perfusion scan.
- Patients with a history of left-sided heart failure will be excluded.
- Patients will also exclude if they are on regular treatment with nitrates or PDE-5 inhibitors (Sildenafil, Tadalafil, Vardenafil).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilAcute single dose of 100 mg of sildenafil. Oral intake in tablet form. | Drug | Sildenafil |
Primary outcome
VO2 Peak
Time frame: 2-30 days between exercise tests
6 min walk test
Time frame: 2-30 days between exercise tests
Distance walked in 6 min test
Functional Tests
Time frame: 2-30 days between exercise tests
1. 30 seconds chair stand test- number of repetitions in 30 sec 2. 8-ft-up-and -go (agility and coordination)- number of sec that takes to complete the task.
2 secondary outcomes
Pulmonary Arterial Pressure
Time frame: 2-30 days between exercise tests
NT-pro-BNP
Time frame: 2-30 days between exercise tests
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2012.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mordechai R Kramer, M.D principal investigator
Rabin Medical Center, Belinson Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sildenafil in people with Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 Peak (time frame: 2-30 days between exercise tests). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2012.