A Study to Diagnose Lung Cancer by Sputum Cytology (01-312)

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210080
• Other study ID #: 01-312
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 3, 2015
• Start date: April 2001
• Est. completion date: December 2003

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Uridine 5'-Triphosphate (UTP) Solution for Inhalation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of lung cancers (malignancies) diagnosed by sputum cytology
Secondary	Proportion of centrally and peripherally located lung cancers diagnosed by sputum cytology;
Secondary	Proportion of small and large lung cancers diagnosed by sputum cytology;
Secondary	Proportion of lung cancers of various cell types, stages and resectability diagnosed by sputum cytology;
Secondary	Wet weight of sputum expectorated;
Secondary	Macrophage content of sputum