Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02487394
Other study ID # 13-0462
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 2014
Est. completion date June 2016

Study information

Verified date April 2023
Source The University of Texas Medical Branch, Galveston
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of the study is to better understand proteomics of asthma and COPD, and response to therapy. There are two Phases to this study broken into two arms. In Phase I, we propose is to use discovery proteomics and techniques to identify protein expression signatures. Subjects who complete Phase I are eligible, but not required, to enroll in Phase II. In Phase II, we propose to establish and validate the predictive value of protein signatures for treatment responses using inhaled corticosteroids.


Description:

There are two Phases to this study broken into two arms. In Phase I, our propose to use discovery proteomics and high throughput techniques to identify protein expression signatures. The total planned size of Phase I is 100 patients. Patients will be divided into two arms based on disease status (COPD or asthma). 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. In the Phase II, we aim to establish and validate the predictive value of proteomic signatures for therapeutic responses using inhaled corticosteroids. For Phase II, subjects who completed Phase I are eligible, but not required to participate in Phase II.


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Criteria for Asthma INCLUSION - History consistent with asthma: episodic wheezing, shortness of breath, or cough - Airway lability recognized by at least 12% improvement in Forced Expiratory Volume (FEV1) after 2 puffs of beta2 agonist Age >18yrs - FEV1 >40% predicted - Never smoker, current smoker, or quit smoking =5 years ago Criteria for COPD INCLUSION - History consistent with COPD: dyspnea with exertion, productive cough, progressive course - Smoking history of at least 20 pack years - Current smoker or quit smoking =5 years ago - Age >18yrs - FEV1: Forced Vital Capacity (FVC) ratio < 0.70 following 2 puffs of albuterol - FEV1 greater than 50% predicted Exclusion Criteria: - Exclusion for Asthma EXCLUSION - Other respiratory illness other than asthma - Chronic infectious process - Significant other medical illness - Inability to consent - Pregnancy Exclusion for COPD EXCLUSION - Other respiratory illness other than COPD - Chronic infectious process - Significant other medical illness - Inability to consent - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Exhaled Breath Condensate (EBC)
Collection of EBC condensate

Locations

Country Name City State
United States University of Texas Medical Branch Galveston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exhaled Breath Condensate Protein Concentration Protein concentrations were below the limit of detectability and are not scientifically robust. 1 year through study completion
See also
  Status Clinical Trial Phase
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device