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.

Study identifier:D5980C00023

ClinicalTrials.gov identifier:NCT04078126

EudraCT identifier:2019-001801-26

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 3

Healthy volunteers

No

Study drug

BFF, Symbicort Turbuhaler

Sex

All

Actual Enrollment

35

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 10 Sept 2019
Primary Completion Date: 30 Dec 2020
Study Completion Date: 30 Dec 2020

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2022 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria