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Assessment of Bronchodilator Efficacy of Formoterol/Budesonide 12/400 mcg Via Discair in COPD

NCT03028701 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-06-16

No results posted yet for this study

Summary

The overall objective is to asses the bronchodilator effect of single dose of Formoterol/Budesonide 12/400 mcg fixed combination delivered via Discair® in patients with COPD.

Spirometric measurements (FEV1, FVC) will be performed for a period of 12 h at 12 different times: pretreatment (prior to the first dose) and posttreatment (15. min, 30. min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr ve 12 hr).

Conditions

Interventions

DRUG

Formoterol/Budesonide 12/400 mcg Discair

Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair®

Sponsors & Collaborators

  • Neutec Ar-Ge San ve Tic A.Ş

    lead INDUSTRY

Principal Investigators

  • Pınar Yıldız, Assoc. Prof. · Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital Istanbul, Turkey, 34020

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03028701 on ClinicalTrials.gov