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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
Enrollment 10

Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description healthy lifetime non smokers were challenged with 4 respiratory manouvers: quiet breathing, hypocapnic hyperventilation, hypercapnic hyperventilation, and eucapnic hyperventilation in random order.
Period Title: Overall Study
Started 10
Quiet Breathing 10
Hypocapnic Hyperventilation 10
Hypercapnic Hyperventilation 10
Eucapnic Hyperventilation 10
Completed 10
Not Completed 0
Arm/Group Title Controls
Hide Arm/Group Description health-lifetime non-smokers were enrolled
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
45
(23 to 54)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
6
  60.0%
Male
4
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Changes in Airway Blood Flow After 180μg Albuterol by Inhalation (ΔQaw) vs Baseline
Hide Description Effect of airway pH on albuterol responsiveness as reflected by the change in airway blood flow after 180μg albuterol by inhalation (ΔQaw) vs baseline.
Time Frame 15 minutes after albuterol inhalation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Health Controls
Hide Arm/Group Description:
Health lifetime non smokers were recruited.
Overall Number of Participants Analyzed 10
Mean (Standard Error)
Unit of Measure: changes from baseline in μl.min-1.ml-1
quiet breathing 16.8  (1.9)
eucapnic hyperventilation 14.5  (2.4)
hypocapnic hyperventilation -0.2  (1.8)
hypercapnic hyperventilation 2.0  (1.5)
2.Secondary Outcome
Title Exhaled Breath Condensate (EBC) pH Variation
Hide Description

EBC samples were collected at each respiratory maneuver by directing the subject's exhaled breath into a pre-cooled (-10C) tube for 10 min.

pH was measured immediately after collection.

Time Frame 10 minutes after each respiratory manouver.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Health Controls
Hide Arm/Group Description:
Health lifetime non smokers were recruited.
Overall Number of Participants Analyzed 10
Mean (Standard Error)
Unit of Measure: pH
quiet breathing 6.39  (0.14)
hypocapnic hyperventilation 6.31  (0.08)
hypercapnic hyperventilation 6.59  (0.15)
eucapnic hyperventilation 5.88  (0.14)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Health Controls
Hide Arm/Group Description Health lifetime non smokers were recruited.
All-Cause Mortality
Health Controls
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Health Controls
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Health Controls
Affected / at Risk (%)
Total   0/10 (0.00%) 
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
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