Diffuse Parenchymal Lung DiseaseNCT01948518
Effect of Sildenafil on Diffusion Capacity in Patients With PH and Parenchymal Lung Disease
A study testing Oral sildenafil 20 mg in people with Diffuse Parenchymal Lung Disease and Pulmonary Hypertension, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study was to investigate the acute effects of sildenafil on diffusion capacity, a commonly performed pulmonary function test, which is used to assess the lungs' gas exchange capability. This study does not assess safety or efficacy of the drug. The study does not have clinical end points. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Parenchymal Lung Disease, Pulmonary Hypertension
- What is being tested?
- Oral sildenafil 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over age 18 years of age who are able to consent
- Diagnosis of diffuse parenchymal lung disease with concomitant pulmonary hypertension
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sildenafil on Diffusion Capacity Measurements in Patients With Pulmonary Hypertension and Parenchymal Lung Disease
The purpose of this study was to investigate the acute effects of sildenafil on diffusion capacity, a commonly performed pulmonary function test, which is used to assess the lungs' gas exchange capability.
This study does not assess safety or efficacy of the drug. The study does not have clinical end points. The variables studied are diffusion capacity and 6 minute walk after a single dose of sildenafil.
This study has been completed.
Read the detailed description
Sildenafil is a cyclic GMP selective phosphodiesterase type 5 inhibitor approved for use by the FDA in patients with pulmonary arterial hypertension. There has been recent interest in the use of the drug in patients with diffuse parenchymal lung diseases. This is largely based on sildenafil's salutary effects observed in small studies (Collard et al. 897-99;Ghofrani et al. 895-900;Collard et al. 897-99) and the frequent coexistence of pulmonary hypertension in these patients (Nathan et al. 657-63). In eight patients with pulmonary fibrosis and pulmonary hypertension, sildenafil reduced pulmonary artery pressure and improved shunt fraction as determined by multiple inert gas elimination technique (Ghofrani et al. 895-900;Nathan et al. 657-63). Collard et al demonstrated a 49 meter improvement in 6 minute walk distance in 11 patients with idiopathic pulmonary fibrosis and pulmonary hypertension after 3 months of therapy with sildenafil.
Main theoretical concern with the use of pulmonary arterial vasodilator therapy has been worsening of ventilation perfusion matching due to release of hypoxic vasoconstriction. Such a phenomenon is well recognized during prostacyclin infusion(Ghofrani et al. 895-900;Walmrath et al. 1084-92). Inhaled route seems to circumvent this side effect by preferentially delivering the drug to the alveoli with high V/Q ratios and augmenting blood flow to these regions (Ghofrani et al. 895-900;Walmrath et al. 1084-92). In the only study to address possible effect of systemically administered sildenafil on gas exchange, Ghofrani et al observed improvement in V/Q matching in eight patients using the multiple inert gas elimination technique (MIGET). The authors postulated an enhancement of local defense mechanisms against hypoxia i.e. increased nitric oxide availability to hypoxic alveoli despite oral route of administration(Ghofrani et al. 895-900). In a recent study of 14 normal subjects, oral sildenafil did not effect DLCO measurements at rest, after exercise and under hypoxic conditions(Snyder et al. 421-30).
Diffusion capacity of the lung for carbon monoxide (DLCO) is the clinically available method of assessing gas exchange for practitioners. It is frequently used as a tool for serial monitoring of diffuse parenchymal lung disease. American Thoracic Society has endorsed its use in the assessment of patients with idiopathic interstitial pneumonias(American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias . This Joint Statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS Board of Directors, June 2001 and by The ERS Executive Committee, June 2001 277-304).
The aim of our study was to delineate the effects of orally administered sildenafil on diffusion capacity (absolute value). The significance of this information was twofold. First, it would be helpful clinically to determine the contribution of a pulmonary vasodilator to the change in DLCO to separate this effect from a true clinical change. Second, sildenafil's effect on gas exchange may lead to modifications in therapy such as changes in oxygen flow delivered to patients.
This is not a study that measures clinical outcome or safety of sildenafil. A single dose was administered and effect on diffusion capacity and 6 minute walk were assessed compared to baseline. While we would caution clinicians for rare exceptions to these findings, we believe our data exclude a significant confounding effect in interpretation of diffusion capacity in patients with parenchymal lung disease who are treated for pulmonary hypertension with oral sildenafil. Whether this conclusion holds true at higher doses of sildenafil and in patients with vasodilator response may offer further venues for research.
We were asked to retrospectively register the study at the request of BMC Pulmonary Medicine Journal Editorial Office prior to publication.
- Being tested
- Oral sildenafil 20 mg
- Keywords
- Pulmonary hypertension, Parenchymal Lung Disease, Diffusion Capacity
- Medical subject headings
- Lung Diseases, Interstitial, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral sildenafil 20 mgDrug
Also called sildenafil
A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug.
| Study group | Role | What they receive |
|---|---|---|
| Oral sildenafil 20 mg | Experimental | oral sildenafil, single dose at baseline Receives: Drug: Oral sildenafil 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diffusion Capacity Measured at Baseline and One Hour.
Determine the acute effect of oral sildenafil on diffusion capacity in patients with diffuse parenchymal lung disease and concomitant pulmonary hypertension
Measured: Baseline and one hour
Secondary outcomes (1)
Change in 6 Minute Walk Distance
The change in 6 minutes walk distance from baseline one hour after receiving 20 mg of sildenafil orally will be measured.
Measured: Baseline and one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startJun 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Diffuse Parenchymal Lung DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umur Hatipoglu, MD, The Cleveland Clinic
- Investigators
- Umur Hatipoglu, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948518
- Sponsor's protocol ID
- 08-993
- Status last verified
- Jul 2014
- First submitted
- 18 Sep 2013
- Last updated
- 30 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lettieri CJ, Nathan SD, Barnett SD, Ahmad S, Shorr AF. Prevalence and outcomes of pulmonary arterial hypertension in advanced idiopathic pulmonary fibrosis. Chest. 2006 Mar;129(3):746-52. doi: 10.1378/chest.129.3.746.
PubMed 16537877Hamada K, Nagai S, Tanaka S, Handa T, Shigematsu M, Nagao T, Mishima M, Kitaichi M, Izumi T. Significance of pulmonary arterial pressure and diffusion capacity of the lung as prognosticator in patients with idiopathic pulmonary fibrosis. Chest. 2007 Mar;131(3):650-656. doi: 10.1378/chest.06-1466. Epub 2007 Feb 22.
PubMed 17317730Ghofrani HA, Wiedemann R, Rose F, Schermuly RT, Olschewski H, Weissmann N, Gunther A, Walmrath D, Seeger W, Grimminger F. Sildenafil for treatment of lung fibrosis and pulmonary hypertension: a randomised controlled trial. Lancet. 2002 Sep 21;360(9337):895-900. doi: 10.1016/S0140-6736(02)11024-5.
PubMed 12354470Badesch DB, Hill NS, Burgess G, Rubin LJ, Barst RJ, Galie N, Simonneau G; SUPER Study Group. Sildenafil for pulmonary arterial hypertension associated with connective tissue disease. J Rheumatol. 2007 Dec;34(12):2417-22. Epub 2007 Nov 1.
PubMed 17985403Rubin LJ, Badesch DB, Fleming TR, Galie N, Simonneau G, Ghofrani HA, Oakes M, Layton G, Serdarevic-Pehar M, McLaughlin VV, Barst RJ; SUPER-2 Study Group. Long-term treatment with sildenafil citrate in pulmonary arterial hypertension: the SUPER-2 study. Chest. 2011 Nov;140(5):1274-1283. doi: 10.1378/chest.10-0969. Epub 2011 May 5.
PubMed 21546436Idiopathic Pulmonary Fibrosis Clinical Research Network; Zisman DA, Schwarz M, Anstrom KJ, Collard HR, Flaherty KR, Hunninghake GW. A controlled trial of sildenafil in advanced idiopathic pulmonary fibrosis. N Engl J Med. 2010 Aug 12;363(7):620-8. doi: 10.1056/NEJMoa1002110. Epub 2010 May 18.
PubMed 20484178American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. This joint statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS board of directors, June 2001 and by the ERS Executive Committee, June 2001. Am J Respir Crit Care Med. 2002 Jan 15;165(2):277-304. doi: 10.1164/ajrccm.165.2.ats01. No abstract available.
PubMed 11790668Miller A, Thornton JC, Warshaw R, Anderson H, Teirstein AS, Selikoff IJ. Single breath diffusing capacity in a representative sample of the population of Michigan, a large industrial state. Predicted values, lower limits of normal, and frequencies of abnormality by smoking history. Am Rev Respir Dis. 1983 Mar;127(3):270-7. doi: 10.1164/arrd.1983.127.3.270. No abstract available.
PubMed 6830050Macintyre N, Crapo RO, Viegi G, Johnson DC, van der Grinten CP, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, Gustafsson P, Hankinson J, Jensen R, McKay R, Miller MR, Navajas D, Pedersen OF, Pellegrino R, Wanger J. Standardisation of the single-breath determination of carbon monoxide uptake in the lung. Eur Respir J. 2005 Oct;26(4):720-35. doi: 10.1183/09031936.05.00034905. No abstract available.
PubMed 16204605ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Kazerooni EA, Martinez FJ, Flint A, Jamadar DA, Gross BH, Spizarny DL, Cascade PN, Whyte RI, Lynch JP 3rd, Toews G. Thin-section CT obtained at 10-mm increments versus limited three-level thin-section CT for idiopathic pulmonary fibrosis: correlation with pathologic scoring. AJR Am J Roentgenol. 1997 Oct;169(4):977-83. doi: 10.2214/ajr.169.4.9308447.
PubMed 9308447Collard HR, Anstrom KJ, Schwarz MI, Zisman DA. Sildenafil improves walk distance in idiopathic pulmonary fibrosis. Chest. 2007 Mar;131(3):897-899. doi: 10.1378/chest.06-2101.
PubMed 17356110Madden BP, Allenby M, Loke TK, Sheth A. A potential role for sildenafil in the management of pulmonary hypertension in patients with parenchymal lung disease. Vascul Pharmacol. 2006 May;44(5):372-6. doi: 10.1016/j.vph.2006.01.013. Epub 2006 Mar 29.
PubMed 16574495Snyder EM, Olson TP, Johnson BD, Frantz RP. Influence of sildenafil on lung diffusion during exposure to acute hypoxia at rest and during exercise in healthy humans. Eur J Appl Physiol. 2008 Jul;103(4):421-30. doi: 10.1007/s00421-008-0735-5.
PubMed 18369657
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sildenafil on Diffusion Capacity Measurements in Patients With Pulmonary Hypertension and Parenchymal Lung Disease
- ClinicalTrials.gov ID
- NCT01948518
- Acronym / sponsor ID
- 08-993
- Keywords
- Pulmonary hypertension, Parenchymal Lung Disease, Diffusion Capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Posted 30 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate the acute effects of sildenafil on diffusion capacity, a commonly performed pulmonary function test, which is used to assess the lungs' gas exchange capability.
This study does not assess safety or efficacy of the drug. The study does not have clinical end points. The variables studied are diffusion capacity and 6 minute walk after a single dose of sildenafil.
This study has been completed.
Detailed description
Sildenafil is a cyclic GMP selective phosphodiesterase type 5 inhibitor approved for use by the FDA in patients with pulmonary arterial hypertension. There has been recent interest in the use of the drug in patients with diffuse parenchymal lung diseases. This is largely based on sildenafil's salutary effects observed in small studies (Collard et al. 897-99;Ghofrani et al. 895-900;Collard et al. 897-99) and the frequent coexistence of pulmonary hypertension in these patients (Nathan et al. 657-63). In eight patients with pulmonary fibrosis and pulmonary hypertension, sildenafil reduced pulmonary artery pressure and improved shunt fraction as determined by multiple inert gas elimination technique (Ghofrani et al. 895-900;Nathan et al. 657-63). Collard et al demonstrated a 49 meter improvement in 6 minute walk distance in 11 patients with idiopathic pulmonary fibrosis and pulmonary hypertension after 3 months of therapy with sildenafil.
Main theoretical concern with the use of pulmonary arterial vasodilator therapy has been worsening of ventilation perfusion matching due to release of hypoxic vasoconstriction. Such a phenomenon is well recognized during prostacyclin infusion(Ghofrani et al. 895-900;Walmrath et al. 1084-92). Inhaled route seems to circumvent this side effect by preferentially delivering the drug to the alveoli with high V/Q ratios and augmenting blood flow to these regions (Ghofrani et al. 895-900;Walmrath et al. 1084-92). In the only study to address possible effect of systemically administered sildenafil on gas exchange, Ghofrani et al observed improvement in V/Q matching in eight patients using the multiple inert gas elimination technique (MIGET). The authors postulated an enhancement of local defense mechanisms against hypoxia i.e. increased nitric oxide availability to hypoxic alveoli despite oral route of administration(Ghofrani et al. 895-900). In a recent study of 14 normal subjects, oral sildenafil did not effect DLCO measurements at rest, after exercise and under hypoxic conditions(Snyder et al. 421-30).
Diffusion capacity of the lung for carbon monoxide (DLCO) is the clinically available method of assessing gas exchange for practitioners. It is frequently used as a tool for serial monitoring of diffuse parenchymal lung disease. American Thoracic Society has endorsed its use in the assessment of patients with idiopathic interstitial pneumonias(American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias . This Joint Statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS Board of Directors, June 2001 and by The ERS Executive Committee, June 2001 277-304).
The aim of our study was to delineate the effects of orally administered sildenafil on diffusion capacity (absolute value). The significance of this information was twofold. First, it would be helpful clinically to determine the contribution of a pulmonary vasodilator to the change in DLCO to separate this effect from a true clinical change. Second, sildenafil's effect on gas exchange may lead to modifications in therapy such as changes in oxygen flow delivered to patients.
This is not a study that measures clinical outcome or safety of sildenafil. A single dose was administered and effect on diffusion capacity and 6 minute walk were assessed compared to baseline. While we would caution clinicians for rare exceptions to these findings, we believe our data exclude a significant confounding effect in interpretation of diffusion capacity in patients with parenchymal lung disease who are treated for pulmonary hypertension with oral sildenafil. Whether this conclusion holds true at higher doses of sildenafil and in patients with vasodilator response may offer further venues for research.
We were asked to retrospectively register the study at the request of BMC Pulmonary Medicine Journal Editorial Office prior to publication.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral sildenafil 20 mg | Experimental | Drug: Oral sildenafil 20 mgoral sildenafil, single dose at baseline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients over age 18 years of age who are able to consent
- Diagnosis of diffuse parenchymal lung disease with concomitant pulmonary hypertension
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Oral sildenafil 20 mgAlso: sildenafilA single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug. | Drug | Oral sildenafil 20 mg |
Primary outcome
Change in Diffusion Capacity Measured at Baseline and One Hour.
Time frame: Baseline and one hour
Determine the acute effect of oral sildenafil on diffusion capacity in patients with diffuse parenchymal lung disease and concomitant pulmonary hypertension
1 secondary outcome
Change in 6 Minute Walk Distance
Time frame: Baseline and one hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16537877Lettieri CJ, Nathan SD, Barnett SD, Ahmad S, Shorr AF. Prevalence and outcomes of pulmonary arterial hypertension in advanced idiopathic pulmonary fibrosis. Chest. 2006 Mar;129(3):746-52. doi: 10.1378/chest.129.3.746.
- Background: PubMed 17317730Hamada K, Nagai S, Tanaka S, Handa T, Shigematsu M, Nagao T, Mishima M, Kitaichi M, Izumi T. Significance of pulmonary arterial pressure and diffusion capacity of the lung as prognosticator in patients with idiopathic pulmonary fibrosis. Chest. 2007 Mar;131(3):650-656. doi: 10.1378/chest.06-1466. Epub 2007 Feb 22.
- Background: PubMed 12354470Ghofrani HA, Wiedemann R, Rose F, Schermuly RT, Olschewski H, Weissmann N, Gunther A, Walmrath D, Seeger W, Grimminger F. Sildenafil for treatment of lung fibrosis and pulmonary hypertension: a randomised controlled trial. Lancet. 2002 Sep 21;360(9337):895-900. doi: 10.1016/S0140-6736(02)11024-5.
- Background: PubMed 17985403Badesch DB, Hill NS, Burgess G, Rubin LJ, Barst RJ, Galie N, Simonneau G; SUPER Study Group. Sildenafil for pulmonary arterial hypertension associated with connective tissue disease. J Rheumatol. 2007 Dec;34(12):2417-22. Epub 2007 Nov 1.
- Background: PubMed 21546436Rubin LJ, Badesch DB, Fleming TR, Galie N, Simonneau G, Ghofrani HA, Oakes M, Layton G, Serdarevic-Pehar M, McLaughlin VV, Barst RJ; SUPER-2 Study Group. Long-term treatment with sildenafil citrate in pulmonary arterial hypertension: the SUPER-2 study. Chest. 2011 Nov;140(5):1274-1283. doi: 10.1378/chest.10-0969. Epub 2011 May 5.
- Background: PubMed 20484178Idiopathic Pulmonary Fibrosis Clinical Research Network; Zisman DA, Schwarz M, Anstrom KJ, Collard HR, Flaherty KR, Hunninghake GW. A controlled trial of sildenafil in advanced idiopathic pulmonary fibrosis. N Engl J Med. 2010 Aug 12;363(7):620-8. doi: 10.1056/NEJMoa1002110. Epub 2010 May 18.
- Background: PubMed 11790668American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. This joint statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS board of directors, June 2001 and by the ERS Executive Committee, June 2001. Am J Respir Crit Care Med. 2002 Jan 15;165(2):277-304. doi: 10.1164/ajrccm.165.2.ats01. No abstract available.
- Background: PubMed 6830050Miller A, Thornton JC, Warshaw R, Anderson H, Teirstein AS, Selikoff IJ. Single breath diffusing capacity in a representative sample of the population of Michigan, a large industrial state. Predicted values, lower limits of normal, and frequencies of abnormality by smoking history. Am Rev Respir Dis. 1983 Mar;127(3):270-7. doi: 10.1164/arrd.1983.127.3.270. No abstract available.
- Background: PubMed 16204605Macintyre N, Crapo RO, Viegi G, Johnson DC, van der Grinten CP, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, Gustafsson P, Hankinson J, Jensen R, McKay R, Miller MR, Navajas D, Pedersen OF, Pellegrino R, Wanger J. Standardisation of the single-breath determination of carbon monoxide uptake in the lung. Eur Respir J. 2005 Oct;26(4):720-35. doi: 10.1183/09031936.05.00034905. No abstract available.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 9308447Kazerooni EA, Martinez FJ, Flint A, Jamadar DA, Gross BH, Spizarny DL, Cascade PN, Whyte RI, Lynch JP 3rd, Toews G. Thin-section CT obtained at 10-mm increments versus limited three-level thin-section CT for idiopathic pulmonary fibrosis: correlation with pathologic scoring. AJR Am J Roentgenol. 1997 Oct;169(4):977-83. doi: 10.2214/ajr.169.4.9308447.
- Background: PubMed 17356110Collard HR, Anstrom KJ, Schwarz MI, Zisman DA. Sildenafil improves walk distance in idiopathic pulmonary fibrosis. Chest. 2007 Mar;131(3):897-899. doi: 10.1378/chest.06-2101.
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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.
Umur Hatipoglu, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral sildenafil 20 mg in people with Diffuse Parenchymal Lung Disease and Pulmonary Hypertension, run by The Cleveland Clinic at 1 site in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 30 Sep 2014. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Diffusion Capacity Measured at Baseline and One Hour. (time frame: Baseline and one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01948518, which also lists 14 linked publications.
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 30 Sep 2014.