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Trial record 1 of 1 for:    16478862 [PUBMED-IDS]
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Clinical Evidence of pH Dependent ß2 Adrenergic Transport Mechanisms in the Airway

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ClinicalTrials.gov Identifier: NCT01216748
Recruitment Status : Completed
First Posted : October 7, 2010
Results First Posted : December 17, 2014
Last Update Posted : May 27, 2016
Sponsor:
Collaborators:
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
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
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
STARTED   10 
Quiet Breathing   10 
Hypocapnic Hyperventilation   10 
Hypercapnic Hyperventilation   10 
Eucapnic Hyperventilation   10 
COMPLETED   10 
NOT COMPLETED   0 



  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.
No text entered.

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

Baseline Measures
   Controls 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Years]
Median (Full Range)
 45 
 (23 to 54) 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   10 
>=65 years   0 
Gender 
[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
No text entered.


  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
e-mail: msalathe@med.miami.edu


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

Responsible Party: Matthias Salathe, University of Miami
ClinicalTrials.gov 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