Trial Outcomes & Findings for Assessment of Cough Reflex in Lung Transplant Recipients (NCT NCT00584077)

Results Overview

The number of coughs elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (D5W) at the level of the main carina, proximal to airway anastomosis (native airway) and distal to the airway anastomosis (allograft airway).

Recruitment status

COMPLETED

Target enrollment

15 participants

Primary outcome timeframe

15-20 minutes

Results posted on

2018-11-02

Participant Flow

Subjects scheduled to undergo surveillance bronchoscopy were enrolled

Participant milestones

Participant milestones
Measure	Lung Transplant Recipients With Stable Lung Function All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Cough Reflex in Lung Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lung Transplant Recipients With Stable Lung Function n=15 Participants All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous Age	49 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 15-20 minutes

The number of coughs elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (D5W) at the level of the main carina, proximal to airway anastomosis (native airway) and distal to the airway anastomosis (allograft airway).

Outcome measures

Outcome measures
Measure	Lung Transplant Recipients With Stable Lung Function n=15 Participants All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
Number of Coughs	7.3 Coughs Standard Deviation 5.2

SECONDARY outcome

Timeframe: 15-20 minutes

Population: Stable lung transplant recipients

Presence of cough as elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (dextrose solution) at the level of the main carina, native lung airway and proximal and distal to the airway anastomosis. Lung transplant recipients underwent airway evaluations using the above protocel at 1.5 and 12 months after lung transplantation. after undergoing transplantation

Outcome measures

Outcome measures
Measure	Lung Transplant Recipients With Stable Lung Function n=24 Coughs All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year Cough1.5 months with D5W at distal anastomosis	0.63 Coughs Standard Deviation 1.2
to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year Cough 12 months with D5W at distal anastomosis	7.3 Coughs Standard Deviation 5.2
to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year Cough1.5 months with foreceps atdistal anastomosis	0.25 Coughs Standard Deviation 0.46
to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year Cough 12 months with foreceps atdistal anastomosis	3.0 Coughs Standard Deviation 2.3

Adverse Events

Lung Transplant Recipients With Stable Lung Function

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

Alexander Duarte, MD

University of Texas-Galveston

Phone: 409-772-2436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place