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Clinical Evidence of pH Dependent ß2 Adrenergic Transport Mechanisms in the Airway

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. Identifier: NCT01216748
Recruitment Status : Completed
First Posted : October 7, 2010
Results First Posted : December 17, 2014
Last Update Posted : May 27, 2016
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Matthias Salathe, University of Miami

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Healthy Volunteers
Interventions: Other: quiet breathing
Other: Hypocapnic Hyperventilation
Other: Hypercapnic Hyperventilation
Other: eucapnic hyperventilation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
All Study Participants healthy lifetime non smokers were challenged with 4 respiratory manouvers: quiet breathing, hypocapnic hyperventilation, hypercapnic hyperventilation, and eucapnic hyperventilation in random order.

Participant Flow:   Overall Study
    All Study Participants
Quiet Breathing   10 
Hypocapnic Hyperventilation   10 
Hypercapnic Hyperventilation   10 
Eucapnic Hyperventilation   10 

  Baseline Characteristics

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.
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Reporting Groups
Controls health-lifetime non-smokers were enrolled

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (23 to 54) 
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   10 
>=65 years   0 
[Units: Participants]
Female   6 
Male   4 
Region of Enrollment 
[Units: Participants]
United States   10 

  Outcome Measures

1.  Primary:   Changes in Airway Blood Flow After 180μg Albuterol by Inhalation (ΔQaw) vs Baseline   [ Time Frame: 15 minutes after albuterol inhalation ]

2.  Secondary:   Exhaled Breath Condensate (EBC) pH Variation   [ Time Frame: 10 minutes after each respiratory manouver. ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Matthias Salathe, MD
Organization: University of Miami
phone: (305)243-2568

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Matthias Salathe, University of Miami Identifier: NCT01216748     History of Changes
Other Study ID Numbers: 20070583
R01HL060644 ( U.S. NIH Grant/Contract )
First Submitted: October 6, 2010
First Posted: October 7, 2010
Results First Submitted: September 2, 2014
Results First Posted: December 17, 2014
Last Update Posted: May 27, 2016