Trial Outcomes & Findings for Clinical Evidence of pH Dependent ß2 Adrenergic Transport Mechanisms in the Airway (NCT NCT01216748)

NCT ID: NCT01216748

Last Updated: 2016-05-27

Results Overview

Effect of airway pH on albuterol responsiveness as reflected by the change in airway blood flow after 180μg albuterol by inhalation (ΔQaw) vs baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 15 minutes after albuterol inhalation
• Results posted on: 2016-05-27

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	10
Overall Study Quiet Breathing	10
Overall Study Hypocapnic Hyperventilation	10
Overall Study Hypercapnic Hyperventilation	10
Overall Study Eucapnic Hyperventilation	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Controls n=10 Participants health-lifetime non-smokers were enrolled
Age, Continuous	45 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes after albuterol inhalation

Effect of airway pH on albuterol responsiveness as reflected by the change in airway blood flow after 180μg albuterol by inhalation (ΔQaw) vs baseline.

Outcome measures

Measure	Health Controls n=10 Participants Health lifetime non smokers were recruited.
Changes in Airway Blood Flow After 180μg Albuterol by Inhalation (ΔQaw) vs Baseline quiet breathing	16.8 changes from baseline in μl.min-1.ml-1 Standard Error 1.9
Changes in Airway Blood Flow After 180μg Albuterol by Inhalation (ΔQaw) vs Baseline eucapnic hyperventilation	14.5 changes from baseline in μl.min-1.ml-1 Standard Error 2.4
Changes in Airway Blood Flow After 180μg Albuterol by Inhalation (ΔQaw) vs Baseline hypocapnic hyperventilation	-0.2 changes from baseline in μl.min-1.ml-1 Standard Error 1.8
Changes in Airway Blood Flow After 180μg Albuterol by Inhalation (ΔQaw) vs Baseline hypercapnic hyperventilation	2.0 changes from baseline in μl.min-1.ml-1 Standard Error 1.5

SECONDARY outcome

Timeframe: 10 minutes after each respiratory manouver.

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.

Outcome measures

Measure	Health Controls n=10 Participants Health lifetime non smokers were recruited.
Exhaled Breath Condensate (EBC) pH Variation quiet breathing	6.39 pH Standard Error 0.14
Exhaled Breath Condensate (EBC) pH Variation hypocapnic hyperventilation	6.31 pH Standard Error 0.08
Exhaled Breath Condensate (EBC) pH Variation hypercapnic hyperventilation	6.59 pH Standard Error 0.15
Exhaled Breath Condensate (EBC) pH Variation eucapnic hyperventilation	5.88 pH Standard Error 0.14

Adverse Events

Health Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthias Salathe, MD

University of Miami

Phone: (305)243-2568

Email: msalathe@med.miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place