Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Sildenafil in Cystic Fibrosis (CF) Lung Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00659529
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : May 2, 2014
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Jennifer Taylor-Cousar, National Jewish Health

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cystic Fibrosis
Intervention Drug: sildenafil
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-label (All Subjects)
Hide Arm/Group Description

All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.

sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks.

Period Title: Overall Study
Started 36 [1]
Received at Least One Dose of Study Drug 27 [2]
Completed 20 [3]
Not Completed 16
Reason Not Completed
Withdrawal by Subject             4
Protocol Violation             3
Screen failure             9
[1]
There were 9 screen failures (subjects who did not meet inclusion/exclusion criteria)
[2]
Received at least one dose of study drug
[3]
4 patients withdrew as a result of side effects. 3 subjects were withdrawn by the investigator.
Arm/Group Title Open-label (All Subjects)
Hide Arm/Group Description

All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.

sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks.

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
All patiens who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
25.7  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
16
  59.3%
Male
11
  40.7%
FEV1% predicted  
Mean (Standard Deviation)
Unit of measure:  % predicted
Number Analyzed 27 participants
77.5  (19.6)
1.Primary Outcome
Title Sputum Elastase
Hide Description [Not Specified]
Time Frame Pre/post therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed 6 weeks of sildenafil and had available data for pre/post 6 weeks of sildenafil were analyzed. One subject presented to the final study visit with 1 week of previously unreported symptoms consistent with pulmonary exacerbation, and therefore, efficacy data was not analyzed on that subject as pre-specified in the protocol.
Arm/Group Title Open-label (All Subjects)
Hide Arm/Group Description:

All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.

sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks.

Overall Number of Participants Analyzed 18
Mean (95% Confidence Interval)
Unit of Measure: micrograms/mL
-57
(-119 to -18)
2.Secondary Outcome
Title Exhaled Breath Condensate pH
Hide Description [Not Specified]
Time Frame Pre/post therapy
Outcome Measure Data Not Reported
3.Secondary Outcome
Title CFQ-R
Hide Description [Not Specified]
Time Frame Pre/post therapy
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Serum Sildenafil Levels
Hide Description [Not Specified]
Time Frame Pre/during therapy
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-label (All Subjects)
Hide Arm/Group Description

All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.

sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks.

All-Cause Mortality
Open-label (All Subjects)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Open-label (All Subjects)
Affected / at Risk (%) # Events
Total   2/27 (7.41%)    
Gastrointestinal disorders   
Distal Intestinal Obstruction Syndrome [1]  1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders   
CF pulmonary exacerbation  2/27 (7.41%)  2
[1]
Not related to study drug
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-label (All Subjects)
Affected / at Risk (%) # Events
Total   24/27 (88.89%)    
Gastrointestinal disorders   
dyspepsia  4/27 (14.81%) 
General disorders   
Sore throat/throat clearing  6/27 (22.22%) 
Flushing  5/27 (18.52%) 
Insomnia  3/27 (11.11%) 
Musculoskeletal and connective tissue disorders   
myalgia  4/27 (14.81%) 
Nervous system disorders   
headache  6/27 (22.22%) 
Respiratory, thoracic and mediastinal disorders   
rhinorhhea/congestion  9/27 (33.33%) 
Increased cough  6/27 (22.22%) 
Increased/thicker sputum  4/27 (14.81%) 
Chest tigntness/congestion  2/27 (7.41%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer L. Taylor-Cousar, MD
Organization: National Jewish Health
Phone: (303) 270-2764
EMail: Taylor-CousarJ@NJHealth.org
Layout table for additonal information
Responsible Party: Jennifer Taylor-Cousar, National Jewish Health
ClinicalTrials.gov Identifier: NCT00659529    
Other Study ID Numbers: 851R14-8510M3
First Submitted: April 14, 2008
First Posted: April 16, 2008
Results First Submitted: April 1, 2014
Results First Posted: May 2, 2014
Last Update Posted: October 19, 2020