Trial Outcomes & Findings for Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma (NCT NCT02487394)

NCT ID: NCT02487394

Last Updated: 2023-04-18

Results Overview

Protein concentrations were below the limit of detectability and are not scientifically robust.

• Recruitment status: TERMINATED
• Target enrollment: 9 participants
• Primary outcome timeframe: 1 year through study completion
• Results posted on: 2023-04-18

Participant Flow

Anticipated to enroll both smoking and non-smoking asthma subjects. Anticipated to enroll both smoking and non-smoking COPD subjects. NO smoking asthmatic subjects enrolled. NO non-smoking COPD subjects enrolled. There are only two groups.

Participant milestones

Measure	Asthma Subjects-Non-Smokers Asthma subjects were required to have a phyician diagnosis of asthma, requiring as needed beta2 agonists, with or without an inhaled corticosteroid. No smoking asthmatic subjects were included in this arm.	COPD Subjects-Smokers COPD subjects were required to have a physician diagnosis of COPD, and treatment with short- or long-acting muscarinic antagonists, or short- or long-acting beta2 agonists, with or without inhaled corticosteroids. All COPD subjects were current smokers. We did not enroll former smokers in this arm.
Phase 1 STARTED	8	1
Phase 1 COMPLETED	8	0
Phase 1 NOT COMPLETED	0	1
Phase 2 STARTED	4	0
Phase 2 COMPLETED	4	0
Phase 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Asthma Subjects-Non-Smokers Asthma subjects were required to have a phyician diagnosis of asthma, requiring as needed beta2 agonists, with or without an inhaled corticosteroid. No smoking asthmatic subjects were included in this arm.	COPD Subjects-Smokers COPD subjects were required to have a physician diagnosis of COPD, and treatment with short- or long-acting muscarinic antagonists, or short- or long-acting beta2 agonists, with or without inhaled corticosteroids. All COPD subjects were current smokers. We did not enroll former smokers in this arm.
Phase 1 Withdrawal by Subject	0	1

Baseline Characteristics

Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma

Baseline characteristics by cohort

Measure	Asthma, Non-Smokers n=8 Participants No active smoking defined as never smoking or having stopped smoking for 5 years or greater.	COPD, Smokers n=1 Participants Active smoking will be defined as daily use of cigarettes, pipes, cigarillos or cigars at time of entry into the study and through duration of study.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	1 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year through study completion

Population: An observational Study principally for collecting biological samples.

Protein concentrations were below the limit of detectability and are not scientifically robust.

Outcome measures

Measure	COPD, Smokers n=1 Participants For Phase II, Phase II will again be divided into two arms based on active smoking status as discussed previously. Asthma, Smokers and Non-Smokers: Comparing protein expressions between the two groups. COPD, Smokers and Non-Smokers: We will validate the prdictive value of the proteomic signatures for therapeutic responses.	Asthma, Non-Smokers n=8 Participants In Phase I, One arm will contain subjects who are active smokers and the other arm will contain subjects with no active smoking. Active smoking will be defined as daily use of cigarettes, pipes, cigarillos or cigars at time of entry into the study and through duration of study. No active smoking defined as never smoking or having stopped smoking for 5 years or greater. Asthma, Smokers and Non-Smokers: Comparing protein expressions between the two groups. COPD, Smokers and Non-Smokers: We will validate the prdictive value of the proteomic signatures for therapeutic responses.
Exhaled Breath Condensate Protein Concentration	NA ug/ml Standard Deviation 0 All concentrations below the level of detection	NA ug/ml Standard Deviation 0 All concentrations below the level of detection

Adverse Events

Asthma, Non-Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

COPD, Smokers

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

William Calhoun, M.D.

UTMB

Phone: 409-772-1176

Email: wjcalhou@utmb.edu

Results disclosure agreements

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