Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis (STEP-IPF)

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00517933
First received: August 15, 2007
Last updated: June 22, 2015
Last verified: June 2015
Results First Received: November 5, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Pulmonary Fibrosis
Hypertension, Pulmonary
Interventions: Drug: Sildenafil Citrate
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sildenafil / Sildenafil 20 mg oral sildenafil 3 times per day
Placebo / Sildenafil 20 mg oral placebo 3 times per day

Participant Flow for 2 periods

Period 1:   Period 1
    Sildenafil / Sildenafil     Placebo / Sildenafil  
STARTED     89 [1]   91 [2]
COMPLETED     81     85  
NOT COMPLETED     8     6  
Death                 2                 1  
Adverse Event                 4                 4  
Lost to Follow-up                 2                 0  
Underwent lung transplant                 0                 1  
[1] Patients decreased due to death, adverse event, lost to follow up and other (see below)
[2] Patients decreased due to death, adverse event and other (see below)

Period 2:   Period 2
    Sildenafil / Sildenafil     Placebo / Sildenafil  
STARTED     79 [1]   83 [1]
COMPLETED     73     70  
NOT COMPLETED     6     13  
Death                 2                 4  
Adverse Event                 2                 4  
Physician Decision                 1                 0  
Withdrawal by Subject                 1                 3  
Underwent lung transplant                 0                 2  
[1] 2 patients terminated after completion of period one, but before starting period 2



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sildenafil 20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
Placebo 20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Sildenafil     Placebo     Total  
Number of Participants  
[units: participants]
  89     91     180  
Age  
[units: years]
Mean (Standard Deviation)
  69.8  (8.7)     68.2  (9.3)     69.0  (8.9)  
Gender  
[units: participants]
     
Female     14     16     30  
Male     75     75     150  
Region of Enrollment  
[units: participants]
     
United States     89     91     180  



  Outcome Measures
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1.  Primary:   Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)   [ Time Frame: Measured at Week 12 ]

2.  Secondary:   6-minute Walk Distance (6MWT)   [ Time Frame: Baseline, 6 week, 12 week ]

3.  Secondary:   Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance   [ Time Frame: Baseline, week 12 ]

4.  Secondary:   Desaturation During 6-minute Walk Test (6MWT)   [ Time Frame: Week 12 ]

5.  Secondary:   Change in Dyspnea   [ Time Frame: Measured from enrollment to 12 weeks (phase I) ]

6.  Secondary:   University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total   [ Time Frame: Baseline, 6 weeks, 12 weeks ]

7.  Secondary:   Change in Forced Vital Capacity (FVC) Adjusted Values   [ Time Frame: Baseline, Week 12 ]

8.  Secondary:   Forced Vital Capacity (FVC)   [ Time Frame: Baseline, Week 6, Week 12 ]

9.  Secondary:   Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values   [ Time Frame: Baseline, Week 12 ]

10.  Secondary:   Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)   [ Time Frame: Baseline, Week 6, Week 12 ]

11.  Secondary:   Change in Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Adjusted Values)   [ Time Frame: Baseline, 12 week ]

12.  Secondary:   Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Raw Scores)   [ Time Frame: Baseline, 6 week, 12 week ]

13.  Secondary:   Change in St. George’s Respiratory Questionnaire (Total Score) (Adjusted Values)   [ Time Frame: Baseline, 12 week ]

14.  Secondary:   St. George’s Respiratory Questionnaire (Total Score)   [ Time Frame: Baseline, 6 weeks, 12 weeks ]

15.  Secondary:   Change in St. George’s Respiratory Questionnaire (Symptoms Score) Adjusted Value   [ Time Frame: Baseline, 12 weeks ]

16.  Secondary:   St. George’s Respiratory Questionnaire (Symptoms Score)   [ Time Frame: Baseline, 6 weeks, 12 weeks ]

17.  Secondary:   Change in St. George’s Respiratory Questionnaire (Activity Score) Adjusted Value   [ Time Frame: Baseline, 12 weeks ]

18.  Secondary:   St. George’s Respiratory Questionnaire (Activity Score)   [ Time Frame: Baseline, 6 weeks, 12 weeks ]

19.  Secondary:   Change in St. George’s Respiratory Questionnaire (Impacts Score) Adjusted Value   [ Time Frame: Baseline, 12 weeks ]

20.  Secondary:   St. George’s Respiratory Questionnaire (Impacts Score)   [ Time Frame: Baseline, 6 weeks, 12 weeks ]

21.  Secondary:   Change in ICECAP-O Adjusted Value   [ Time Frame: Baseline, 12 weeks ]

22.  Secondary:   ICECAP-O   [ Time Frame: Baseline, 6 weeks, 12 weeks ]

23.  Secondary:   Change in EuroQOL Thermometer (Adjusted Value)   [ Time Frame: Baseline, 12 weeks ]

24.  Secondary:   EuroQOL Thermometer   [ Time Frame: Baseline, 6 weeks, 12 weeks ]

25.  Secondary:   Change in EuroQOL (EQ-5D) Utility - Adjusted Value   [ Time Frame: Baseline, 12 weeks ]

26.  Secondary:   EuroQOL (EQ-5D) Utility   [ Time Frame: Baseline, 6 weeks, 12 weeks ]

27.  Secondary:   Change in Short Form Health Survey (SF36) General Health - Adjusted Value   [ Time Frame: Baseline, 12 weeks ]

28.  Secondary:   Short Form Health Survey (SF36) General Health   [ Time Frame: Baseline, 6 weeks, 12 weeks ]

29.  Secondary:   Change in SF36 Aggregate Physical (Adjusted Value)   [ Time Frame: Baseline, 12 weeks ]

30.  Secondary:   Short Form Health Survey (SF36) Aggregate Physical   [ Time Frame: Baseline, 6 weeks, 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Findings are limited to patients with advanced IPF. It is unknown if treatment effect was driven by particular subgroup of patients. Study was too short and enrolled too few to assess duration of effect.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kevin J Anstrom, PhD
Organization: Duke Clinical Research Institute
phone: 919-668-8902
e-mail: kevin.anstrom@duke.edu


No publications provided by Duke University

Publications automatically indexed to this study:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00517933     History of Changes
Other Study ID Numbers: Pro00018538, U10HL080413, 507
Study First Received: August 15, 2007
Results First Received: November 5, 2010
Last Updated: June 22, 2015
Health Authority: United States: Federal Government