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Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
INO Therapeutics
ClinicalTrials.gov Identifier:
NCT00551642
First received: October 30, 2007
Last updated: March 8, 2013
Last verified: March 2013
Results First Received: September 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Lung Disease
Interventions: Drug: Nitric Oxide for inhalation
Drug: Nitrogen

  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
Thirty-five Medical Centers participated and enrolled a total of 800 subjects (Intent to treat population). The study allowed for a 2 year recruitment and intervention period followed by 7 years of clinical follow up.

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
Inhaled Nitric Oxide (NO) Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
Placebo (Nitrogen) Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days

Participant Flow:   Overall Study
    Inhaled Nitric Oxide (NO)     Placebo (Nitrogen)  
STARTED     399     401  
COMPLETED     338     338  
NOT COMPLETED     61     63  
Withdrawal by Subject                 2                 1  
Adverse Event                 15                 12  
Death                 33                 31  
Protocol Violation                 6                 11  
Physician Decision                 0                 1  
Delivery device failure                 1                 3  
Inclusion/Exclusion criteria                 4                 4  



  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
Inhaled Nitric Oxide (NO) Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
Placebo (Nitrogen) Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
Total Total of all reporting groups

Baseline Measures
    Inhaled Nitric Oxide (NO)     Placebo (Nitrogen)     Total  
Number of Participants  
[units: participants]
  399     401     800  
Age  
[units: participants]
     
<=18 years     399     401     800  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: weeks]
Mean ± Standard Deviation
  26.4  ± 1.3     26.6  ± 1.3     26.5  ± 1.3  
Gender  
[units: participants]
     
Female     192     181     373  
Male     207     220     427  
Region of Enrollment  
[units: participants]
     
France     52     55     107  
Finland     4     4     8  
Spain     76     79     155  
Belgium     37     37     74  
Netherlands     20     20     40  
Germany     114     117     231  
United Kingdom     30     33     63  
Italy     44     34     78  
Sweden     22     22     44  



  Outcome Measures

1.  Primary:   Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress   [ Time Frame: 36 weeks gestational age ]

2.  Primary:   Survival   [ Time Frame: 36 Weeks GA ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Vital Signs   [ Time Frame: Study Duration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Arterial Oxygen Saturation by Pulse Oximetry   [ Time Frame: Study Duration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Adverse Events   [ Time Frame: Study Duration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Methemoglobin Level   [ Time Frame: Baseline, then 24 hours, 2-6 days, Day 7 and Day 14 of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: James Baldassarre, MD
Organization: INO Therapeutics LLC
phone: 908-238-6363
e-mail: james.baldassarre@ikaria.com


No publications provided by INO Therapeutics

Publications automatically indexed to this study:

Responsible Party: INO Therapeutics
ClinicalTrials.gov Identifier: NCT00551642     History of Changes
Other Study ID Numbers: INOT27, EUNO, EU Preemie
Study First Received: October 30, 2007
Results First Received: September 3, 2010
Last Updated: March 8, 2013
Health Authority: European Union: European Medicines Agency