A Study to Diagnose Lung Cancer by Sputum Cytology

This study has been completed.

First Received: September 13, 2005 Last Updated: January 28, 2009 History of Changes

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00210080

Purpose

The primary objective of this study is to determine if more diagnoses of lung cancer are obtained from the cytological evaluation of sputum expectorated following a single inhaled dose of UTP compared to sputum expectorated following a single inhaled dose of placebo in patients suspected of having lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: Uridine 5'-Triphosphate (UTP) Solution for Inhalation	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Double-Blind, Placebo-Controlled, Parallel Group Study of Uridine 5'-Triphosphate (UTP) Solution for Inhalation as an Adjunct in the Diagnosis of Lung Cancer by Sputum Cytology

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Uridine

U.S. FDA Resources

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

Proportion of lung cancers (malignancies) diagnosed by sputum cytology

Secondary Outcome Measures:

Proportion of centrally and peripherally located lung cancers diagnosed by sputum cytology;
Proportion of small and large lung cancers diagnosed by sputum cytology;
Proportion of lung cancers of various cell types, stages and resectability diagnosed by sputum cytology;
Wet weight of sputum expectorated;
Macrophage content of sputum

Estimated Enrollment:	700
Study Start Date:	April 2001

Eligibility

Criteria

Inclusion Criteria:

be suspected of having primary lung cancer based upon chest radiograph(s), CT scan(s), or PET scan(s) and with symptom, risk profile, or history suggestive of malignancy
have FEV1 greater than or equal to 40% predicted normal for age and height

Exclusion Criteria:

have obtained a confirmed diagnosis for the current suspicious lung tumor
have been treated for the current, suspicious tumor except in cases in which the current lesion is the recurrence of the same tumor (same location) for which treatment was administered no less than 180 days prior to screening
have undergone a bronchoscopic examination or pulmonary fine needle aspiration biopsy within 4 days prior to dosing, or have undergone sputum induction within 3 days prior to dosing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210080

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Director:

Amy Schaberg, BSN

Unaffiliated

More Information

No publications provided

Study ID Numbers:	01-312
Study First Received:	September 13, 2005
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00210080 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on September 02, 2009