NCT02566252

Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)

A Randomized, Open-label, Crossover Study to Assess the Safety, Tolerability, and Pharmacodynamics of PUL-042 Inhalation Solution in Healthy Subjects and the Effect of Pretreatment With Cromolyn Sodium or Albuterol Sulfate

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pulmotect, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the effect of pre-treatment with either cromolyn sodium or albuterol sulfate on the safety and tolerability or PUL-042 Inhalation Solution in healthy subjects.

Detailed description

Healthy subjects (8 per cohort) will be randomized to either pre-treatment or no pre-treatment (4 per group). The initial cohort will receive pre-treatment with cromolyn sodium. Subjects will be followed for 2 weeks for safety and tolerability, undergo a 2 week washout period and then be assigned to the alternative treatment (i.e., subjects who received cromolyn sodium prior to PUL-042 inhalation solution will not receive pretreatment) and then followed for an additional 2 weeks. Subsequent cohort will receive pre-treatment with albuterol sulfate in a like manner.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PUL-042 Inhalation Solution	PUL-042
DRUG	Cromolyn Sodium	Pre-treatment
DRUG	Albuterol sulfate	Pre-treatment

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-01-01
• Completion: 2016-03-01
• First posted: 2015-10-02
• Last updated: 2017-08-10

Locations

1 site across 1 country: United States