NCT01096303

Brief Summary

The main hypothesis is that persons that smoke or smoked tobacco and marihuana have worsen lung function as compared with persons that only smoke or smoked tobacco.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

March 24, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

6.2 years

First QC Date

March 24, 2010

Last Update Submit

May 12, 2017

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDpulmonary functiontobacco and marihuana smoking

Outcome Measures

Primary Outcomes (1)

  • Obstructive limitation in pulmonary function test

    Comparison on the severity of obstruction among both groups

    1 year

Secondary Outcomes (2)

  • Decreased diffusion capacity for carbon monoxide

    1 year

  • Airtrapping

    1 year

Study Arms (1)

COPD tobacco and/or marihuana users

COPD patients with history of tobacco and/or marihuana smoking.

Eligibility Criteria

Age25 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients recruited in pulmonary clinic.

You may qualify if:

  • COPD patients former or current tobacco smokers
  • COPD patients former or current tobacco and marihuana smokers

You may not qualify if:

  • History of COPD without pulmonary function testing
  • Refusal to provide smoking or marihuana used history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lyndon B Johnson General Hospital

Houston, Texas, 77026, United States

Location

The University of Texas- Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMarijuana Smoking

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMarijuana UseBehaviorSmoking, Non-Tobacco ProductsSmoking

Study Officials

  • Rosa M Estrada-Y-Martin, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor - I/M Pulmonary and Critical Care

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 31, 2010

Study Start

November 1, 2010

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

May 15, 2017

Record last verified: 2017-05

Locations

US(2)