NCT01733485

Brief Summary

Asthma is an inflammatory disease, which means it causes swelling in the lungs to cause shortness of breath and/or wheezing. There are several asthma medications that help to reduce this problem. The objective of this research study is to characterize the presence of electrophilic fatty acids in the bronchial airway of subjects with controlled asthma at baseline and after treatment with Aspirin, Indomethacin, or no treatment at all. The presence of electrophilic fatty acids may indicate inflammation. Aspirin and Indomethacin are known to respectively increase and inhibit the formation of electrophilic fatty acids. By gaining a better understanding of how electrophilic fatty acids work and how they respond to different treatment, researchers hope to be able to find better ways to lessen airway inflammation in asthma in the future.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 asthma

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_1 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

4.9 years

First QC Date

November 15, 2012

Last Update Submit

July 5, 2017

Conditions

AsthmaElectrophilic Fatty Acids

Keywords

AsthmaElectrophilic Fatty AcidsInflammation

Outcome Measures

Primary Outcomes (1)

  • Airway concentration of electrophilic fatty acids

    Patients undergo a baseline bronchoscopy, afterwhich they are randomized to 5 days of a)indomethacin, b) aspirin, c) nothing . After treatment, another bronchoscopy is done. Outcomes are determined after each bronchoscopy

    Change in the bronchoalveolar lavage concentration of electrophilic fatty acids from the first to the second bronchoscopy

Study Arms (3)

Aspirin

ACTIVE COMPARATOR
Drug: Aspirin

Indomethacin

ACTIVE COMPARATOR
Drug: Indomethacin

Control

NO INTERVENTION

Interventions

AspirinDRUG

500 mg/8 h for 5 days

Aspirin
IndomethacinDRUG

25 mg/8 h for 5 days

Indomethacin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of mild to moderate asthma
  • No evidence of a previous asthma exacerbation in the preceding 6 weeks (defined as increased severity of respiratory symptoms requiring systemic steroids or escalation of therapy; b) asthma control questionnaire (ACQ) score less than 1.

You may not qualify if:

  • Diagnosis of severe asthma, vocal cord dysfunction, cystic fibrosis, COPD, CAD, hypertension, diabetes or renal failure that is not well controlled
  • Greater than 10 pack-year history of smoking;
  • Stopped smoking less than 1 year prior to study,
  • Taking any aspirin or other NSAIDS on the week prior to bronchoscopy,
  • Taking omega-3 fatty acid supplements
  • If a subject is currently taking an omega-3 fatty acid supplement and is interested in the study, after a 30 day wash out, the participant can be re-screened and evaluated for participation.
  • Taking pioglitazone or rosiglitazone (synthetic thiazolidinedione PPARg ligands);
  • other known pulmonary diseases;
  • Inability to undergo bronchoscopy,
  • Contraindications or allergy to aspirin or indomethacin,
  • Asthmatics with known hypersensitivity to aspirin, and
  • Steroid (systemic) dependent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

AsthmaInflammation

Interventions

AspirinIndomethacin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Fernando Holguin, MD MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 27, 2012

Study Start

October 1, 2011

Primary Completion

September 1, 2016

Study Completion

June 1, 2017

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

US(1)