NCT00596232

Brief Summary

The purpose of this study is to investigate how mucus (phlegm or spit) is broken down once it forms in the airways (bronchial tubes) of people with lung disease. This research study will also examine whether blood groups have an effect on lung function or the type of mucus found in the lung. This study is not designed to be a treatment for asthma, emphysema, cystic fibrosis, or other lung disease. It is designed to help the investigators learn more about the causes of airway disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
211

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2003

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

12.7 years

First QC Date

January 2, 2008

Last Update Submit

April 28, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • rheological measurements (viscosity and elasticity) in sputum.

    2-3 years

Study Arms (3)

Asthma

People who have been diagnosed with Asthma

Cystic Fibrosis

People who have been diagnosed with Cystic Fibrosis

Healthy

People who are non-asthmatic, non smokers with less than 10 pack years and who do not have cystic fibrosis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Volunteers are recruited from community advertisements and health clinics

You may qualify if:

  • Asthma:
  • Male and female subjects aged 18 - 70 years
  • Medical history consistent with asthma
  • PC20 (provocative concentration causing a 20% fall) methacholine ≤ 8 mg/ml for subjects not taking inhaled corticosteroids
  • PC20 methacholine ≤ 16 mg/ml for subjects taking inhaled corticosteroids
  • Ability to provide informed consent
  • Cystic Fibrosis:
  • Male and female subjects aged 18-55 years
  • Prior diagnosis of cystic fibrosis
  • Ability to provide informed consent
  • Healthy:
  • Male and female subjects aged 18-70 years
  • No current smoking history
  • No history of asthma or allergic rhinitis
  • FEV1 (forced expiratory volume in 1 second) \> 80% predicted
  • +1 more criteria

You may not qualify if:

  • Recent heart attack or stroke
  • Known aortic or cerebral aneurysm
  • Uncontrolled hypertension
  • Pregnancy
  • Lactation
  • Lung disease other than asthma,cystic fibrosis, or chronic obstructive pulmonary disease (COPD)/emphysema/chronic bronchitis
  • Upper- or lower-respiratory tract infection 6 weeks prior to study enrollment
  • Significant asthma exacerbation 6 weeks prior to study enrollment
  • Increasing hyposensitization therapy for the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Airway Clinical Research Center

San Francisco, California, 94143, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum

MeSH Terms

Conditions

AsthmaCystic Fibrosis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPancreatic DiseasesDigestive System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • John V Fahy, M.D., M.Sc.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 16, 2008

Study Start

April 1, 2003

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations