NCT04078126

Study Comparing Dual Combination of Product (Budesonide and Formoterol) Given Via Two Different Inhalers. To See Which One Results in the Best Effect on Breathing.

A Randomized, Open-Label, Two Period Crossover, Chronic Dosing, 1-Week, Pilot Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Inhalation Aerosol Administered With a Spacer Compared With Symbicort® Turbuhaler® in Subjects With Severe to Very Severe Chronic Obstructive Pulmonary Disease and Low Peak Inspiratory Flow

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Study comparing the same drugs as a dual combination product (budesonide and formoterol) given via two different inhalers. To see which one results in the best effect on breathing.

Detailed description

This is a Randomized, Open-Label, Two Period Crossover, Chronic Dosing, 1-Week, Pilot Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Inhalation Aerosol Administered with a Spacer Compared with Symbicort® Turbuhaler® in Subjects with Severe to Very Severe Chronic Obstructive Pulmonary Disease and Low Peak Inspiratory Flow to assess lung function

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	BFF	Treatment with budesonide and formoterol furmate MDI (metered-dose inhaler)
COMBINATION_PRODUCT	Symbicort Turbuhaler	Treatment with budesonide and formoterol furmate DPI (dry-powder inhaler)

Timeline

• Start date: 2019-09-10
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2019-09-04
• Last updated: 2022-03-18
• Results posted: 2022-03-18

Locations

4 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study