MedTrace Logo

Tiotropium/Formoterol Via Discair® vs Tiotropium Monotherapy or Tiotropium + Formoterol Free Combination Treatment

NCT02988869 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2020-06-16

No results posted yet for this study

Summary

The overall objective is to asses the bronchodilator effect of once daily Tiotropium/Formoterol combination delivered via Discair® by comparing Tiotropium (q.d.) monotherapy delivered via Handihaler and tiotropium (q.d.) delivered via Handihaler + formoterol (b.i.d) delivered via Aerolizer free combination treatment in patients with stable moderate to severe COPD.

Spirometric measurements (FEV1, FVC) will be performed for a period of 24 h at 12 different times: pre-treatment (15 min prior to the first dose) and post-treatment (30. min, 60 min \[1 hr\], 120 min \[2 hr\], 180 min \[3 hr\], 240 min \[4 hr\], 360 min \[6 hr\], 480 min \[8 hr\], 600 min \[10 hr\], 720 min \[12 hr\], 840 min \[14 hr\],1440 min \[24 hr\].

Conditions

Interventions

DRUG

Tiotropium/Formoterol

Tiotropium/Formoterol 18/12 mcg Inhalation Powder (1 puff) once daily via Discair®

DRUG

Tiotropium

Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler

DRUG

Formoterol

Formoterol 12 mcg Inhalation Powder (1 puff) twice daily via Aerolizer

DRUG

Tiotropium

Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler

Sponsors & Collaborators

  • Neutec Ar-Ge San ve Tic A.Ş

    lead INDUSTRY

Principal Investigators

  • Pinar Yildiz, Professor Doctor · Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital-Turkey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-08-31
Completion
2017-08-31

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 NCT02988869 on ClinicalTrials.gov