The Effect of Inhaled PUL-042 on Rhinovirus-induced Symptoms in Smokers With GOLD Stage 0 COPD

COPD Clinical Trial

Official title: A Phase 2, Single-Center, Double-Blind, Placebo-Controlled, Study of PUL-042 Inhalation Solution in Rhinovirus-induced Symptoms in Current Smokers With Gold Stage 0 Chronic Obstructive Pulmonary Disease (COPD)

Status Completed

Clinical Trial Summary

This is a study examining the effect of inhaled PUL-042 on peak lower respiratory symptoms as measured by subject diary in early stage COPD subjects who are experimentally infected with rhinovirus. Subjects will receive 1 dose of PUL-042 followed by inoculation with HRV A16 virus 24 hours later. An additional dose of PUL-042 will be administered 48 hours post-inoculation. Subjects will be followed for 6 weeks post-inoculation

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled Phase 2 study examining the effects of inhaled PUL-042 on Lower Respiratory Symptom Score (LRSS) in GOLD stage 0 COPD patients. Smoking subjects (>10 pyh) with symptoms suggestive of early COPD (cough, sputum production but normal spirometry, meeting GOLD 0 criteria) will be screened. Following screening (days -21 to -11 prior to infection), eligible subjects will be enrolled and will undergo a baseline sampling visit on study day -8 and will complete questionnaires from study day -8 to -2 (7 days total) recording their baseline symptoms There will be two treatment arms in the study. The arms will be: - Placebo administered on study day -1 and study day 2 - PUL-042 administered on study day -1 and PUL-042 administered on study day 2 On day 0 subjects will be experimentally infected with HRV A16 (100 TCID50) via an atomizer to the upper airway. Subjects will subsequently be required to attend the clinic on study days 1-7, 9, 12, 15, 21 and 42 for follow up visits. Subjects will continue their diaries at home during the period when not attending clinic visits, namely days 8, 10, 11, 13, 14, 16-20 and 22-41. Spirometry assessments will be conducted by clinic staff on clinic visit days. PEF, FEV1, FVC and FEV1/FVC ratio will be completed at the visit using the clinic study-supplied spirometry equipment. Sputum samples and serum will be analyzed for inflammatory markers. Serum samples will be obtained from subjects at screening and during clinic visits on study days -1, 0, 2, 3, 5, 7, 9, 12, 15, 21 and 42. Sputum samples will be obtained at baseline (BL) and on study days -1, 0, 2, 5, 7, 9, 12, 15, and 21. Nasal lavage samples will be collected during baseline (BL) and on study days -1, 0, 1-7, 9, 12, 15, 21 and 42 for assessment of virus load and pro-inflammatory cytokines etc. in the upper airway. Subjects will be asked to complete the following questionnaires on days -8 to day 42 during the study: 1. The lower respiratory symptom scores as measured by Mallia 2. The upper respiratory symptoms measured by the Jackson score as measured by Mallia 3. The COPD Assessment Test (CAT) score 4. The EXACT-RS Lower Respiratory Symptom questionnaire 5. The Wisconsin Upper Respiratory Symptom Survey-11 (WURSS-11) 6. Subjects will record any medication use in a specific diary. ;

Related Conditions & MeSH terms

• COPD

• NCT number: NCT03794557
• Study type: Interventional
• Source: Pulmotect, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: January 21, 2019
• Completion date: March 23, 2021