Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis

NCT00981747 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 200906736
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether combination therapy with sildenafil and losartan can improve function and exercise tolerance in patients with idiopathic pulmonary fibrosis.

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change in Six Minute Walk Distance in Meters

  Change in 6MWD before and after treatment compared to placebo

  At baseline and three months post each intervention.

Secondary Outcomes (2)

• Change in Forced Vital Capacity (FVC)

  At baseline and three months post each intervention.

• Change in Shortness of Breath (SOB) Score

  At baseline and three months post each intervention.

Study Arms (1)

All study participants

EXPERIMENTAL

Study participants are patients that have been diagnosed with idiopathic pulmonary fibrosis (IPF).

Drug: Sildenafil; Drug: Losartan; Drug: Sildenafil and Losartan; Drug: Placebo Oral Tablet

Interventions

Sildenafil DRUG

Sildenafil 20mg three times per day for 3 months followed by a one month washout prior to next intervention.

Also known as: Viagra, Revatio

All study participants

Losartan DRUG

Losartan 25mg two times a day for 3 months followed by a one month washout prior to next intervention.

Also known as: Cozaar: losartan

All study participants

Sildenafil and Losartan DRUG

Sildenafil 20mg three times per day and Losartan 25mg two times per day followed by a one month washout prior to next intervention.

Also known as: Viagra, Revatio: sildenafil, Cozaar: losartan

All study participants

Placebo Oral Tablet DRUG

Placebo pill three times per day for 3 months followed by a one month washout prior to next intervention.

Also known as: Placebo pill (sugar)

All study participants

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-99
• Have not taken any of the study medications in the past 6 weeks
• Diagnosed with idiopathic pulmonary fibrosis

You may not qualify if:

• FVC\<50%, DLco \<30% or FEV1/FVC ratio \<65%
• Greater amount of emphysema than fibrotic change on chest CT scan
• Acute myocardial infarction within the past 6 months
• Nitrate use
• Contraindications, hypersensitivity, or allergic reaction to any study medication
• Presence of aortic stenosis
• Life-threatening arrhythmia within 1 month of evaluation
• Diabetes requiring insulin therapy
• Second-degree or third-degree atrioventricular block on electrocardiogram
• Echocardiographic evidence of severe pulmonary hypertension (\>50mmHg) • Severe terminal illness (survival predicted to be less than 1 year)
• Severe congestive heart failure
• Renal impairment (creatinine \>2.0 mg/dl)
• Moderate to severe hepatic impairment
• Concurrent treatment with immunosuppressive, cytotoxic, or investigational agents.
• Pregnant or Breastfeeding (Women of childbearing age must use effective form of birth control or abstinence during study participation)

Sponsors & Collaborators

• Alicia Gerke: lead
• Pulmonary Fibrosis Foundation: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52246, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Interventions

Sildenafil Citrate; Losartan; Sugars

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Tetrazoles; Carbohydrates

Limitations and Caveats

The trial was terminated early due to funding issues. Therefore, power to find a difference is limited.

Results Point of Contact

• Title: Dr. Alicia Gerke
• Organization: University of Iowa

alicia-gerke@uiowa.edu

319-356-1616

Study Officials

• Alicia K Gerke, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will receive sildenafil for three months then losartan for three months, then sildenafil and losartan for three months and then placebo for three months in a random order.

Study Record Dates

• First Submitted: September 19, 2009
• First Posted: September 22, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 13, 2018
• Results First Posted: November 13, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)