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Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis

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: NCT00570349
Recruitment Status : Completed
First Posted : December 10, 2007
Results First Posted : December 1, 2010
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cystic Fibrosis
Interventions Drug: Nitric Oxide for Inhalation
Drug: Nitrogen
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Inhaled Nitric Oxide Low Dose Inhaled Nitric Oxide High Dose Nitrogen
Hide Arm/Group Description Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours. Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
Period Title: Overall Study
Started 6 6 6
Completed 6 6 6
Not Completed 0 0 0
Arm/Group Title Inhaled Nitric Oxide Low Dose Inhaled Nitric Oxide High Dose Nitrogen Total
Hide Arm/Group Description Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours. Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 18 participants
<=18 years
5
  83.3%
5
  83.3%
3
  50.0%
13
  72.2%
Between 18 and 65 years
1
  16.7%
1
  16.7%
3
  50.0%
5
  27.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 18 participants
16.9  (2.14) 15.6  (2.33) 17.7  (5.14) 16.7  (3.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 18 participants
Female
2
  33.3%
2
  33.3%
1
  16.7%
5
  27.8%
Male
4
  66.7%
4
  66.7%
5
  83.3%
13
  72.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 6 participants 18 participants
6 6 6 18
1.Primary Outcome
Title Safety and Tolerability of Drug, Assessed by Change in Methemoglobin Levels
Hide Description Methemoglobin level assessments were measured through blood draws - hematology. This test measures the amount of methemoglobin (a type of hemoglobin that is unable to transport oxygen to tissues) in blood. Normal methemoglobin percentage range 1% - 2%.
Time Frame Baseline and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Nitric Oxide Low Dose Inhaled Nitric Oxide High Dose Nitrogen
Hide Arm/Group Description:
Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
Overall Number of Participants Analyzed 6 6 6
Mean (Standard Deviation)
Unit of Measure: Percent of Methemoglobin Level
Methemoglobin Levels at Baseline 0.4  (0.14) 0.5  (0.48) 0.3  (0.19)
Methemoglobin Levels at 48 hours 0.3  (0.14) 0.1  (0.10) 0.4  (0.21)
2.Primary Outcome
Title Change in Oxygen Saturation
Hide Description

Safety and tolerability of drug assessed by decreased oxygen saturation was measured through pulse oximeter, which measure the amount of oxygen in the blood.

Normal range percentage is 95 - 100%

Time Frame Baseline and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Nitric Oxide Low Dose Inhaled Nitric Oxide High Dose Nitrogen
Hide Arm/Group Description:
Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
Overall Number of Participants Analyzed 6 6 6
Mean (Standard Deviation)
Unit of Measure: Percent of oxygen saturation
Oxygen Saturation at Baseline 95.5  (1.87) 94.8  (2.14) 95.5  (2.66)
Oxygen Saturation at 48 hours 95.7  (2.16) 95.8  (3.19) 97.0  (1.10)
3.Primary Outcome
Title Change in Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Decrease in forced expiratory volume in 1 second was measured through spirometer. Spirometer measures the volume of air inspired and expired by the lungs.
Time Frame Baseline and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Nitric Oxide Low Dose Inhaled Nitric Oxide High Dose Nitrogen
Hide Arm/Group Description:
Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
Overall Number of Participants Analyzed 6 6 6
Mean (Standard Deviation)
Unit of Measure: Liters
Forced Expiratory Volume in 1 second at Baseline 3.4  (0.66) 3.1  (1.07) 3.0  (0.85)
Forced Expiratory Volume in 1 second at 48 hours 3.5  (0.66) 3.1  (1.17) 3.0  (0.83)
4.Secondary Outcome
Title Assess the Difference in Sputum Bacterial Density Before and After NO Inhalation. Assess the Difference in Lower Airway Inflammatory Measures Before and After NO Inhalation
Hide Description [Not Specified]
Time Frame 44 hours
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Inhaled Nitric Oxide Low Dose Inhaled Nitric Oxide High Dose Nitrogen
Hide Arm/Group Description Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours. Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
All-Cause Mortality
Inhaled Nitric Oxide Low Dose Inhaled Nitric Oxide High Dose Nitrogen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Inhaled Nitric Oxide Low Dose Inhaled Nitric Oxide High Dose Nitrogen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Inhaled Nitric Oxide Low Dose Inhaled Nitric Oxide High Dose Nitrogen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      1/6 (16.67%)      0/6 (0.00%)    
Infections and infestations       
Otitis Media   1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough *  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Epistaxis *  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Brahm Goldstein
Organization: INO Therapeutics
Phone: 908-238-6495
EMail: brahm.goldstein@ikaria.com
Layout table for additonal information
Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00570349     History of Changes
Other Study ID Numbers: INOT 50
First Submitted: December 6, 2007
First Posted: December 10, 2007
Results First Submitted: October 1, 2010
Results First Posted: December 1, 2010
Last Update Posted: June 16, 2016