Clinical Trials Logo

Clinical Trial 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).


Clinical Trial Description

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

Patients will be assigned to receive single dose of Formoterol/Budesonide 12/400 mcg fixed dose combination delivered via Discair® (test product, n = 33). Patients will be evaluated at 4 consecutive visits: baseline (enrollment), screening, treatment, and end of treatment (24h after treatment).

For newly diagnosed and formerly diagnosed patients who are not on COPD medication, the screening visit will be performed on the day of enrollment. For formerly diagnosed patients receiving COPD treatment, the day of the screening visit will be based on the completion of a run-in period, with the length determined by the specific medication. During the run-in period, salbutamol (100 μg inhaler) will be prescribed as a rescue medication.

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03028701
Study type Interventional
Source Neutec Ar-Ge San ve Tic A.S
Contact
Status Completed
Phase Phase 4
Start date September 2015
Completion date March 2017

See also
  Status Clinical Trial Phase
Recruiting NCT03640260 - Respiratory Regulation With Biofeedback in COPD N/A
Recruiting NCT03284203 - Feasibility of SpiroPD N/A
Not yet recruiting NCT03644888 - Continuous Chest Wall Vibration in COPD Rehabilitation N/A
Enrolling by invitation NCT03468101 - Characterization of Professional COPD Related to Exposure to Organic Dust - Mean Follow up at 6 Years
Not yet recruiting NCT03611036 - Effect of Different Form of Upper Limb Muscles Training on Dyspnea in COPD N/A
Not yet recruiting NCT03655795 - Autologous Transplantation of Bronchial Basal Cells for Treatment of COPD Phase 1
Not yet recruiting NCT03278795 - VSV Versus PSV as a Weaning Mode of Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients N/A
Recruiting NCT02815683 - Bronchoscopic EmphysemA Treatment in THE NetherLands N/A
Not yet recruiting NCT02914093 - IMT in Hypercapnic Patients With COPD N/A
Not yet recruiting NCT02881385 - Effects on Respiratory Patterns and Patient-ventilator Synchrony Using Pressure Support Ventilation N/A
Recruiting NCT02515318 - Physiotherapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease N/A
Recruiting NCT02807025 - Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases N/A
Completed NCT02509299 - Effect of Physiotherapy on Perceived Health Status in Hospitalized COPD Patients N/A
Completed NCT02750189 - The Economic Burden of Chronic Obstructive Pulmonary Disease(COPD) in South Korea N/A
Completed NCT02517411 - Physiotherapy in Patients With Stable Chronic Obstructive Pulmonary Disease N/A
Recruiting NCT03026439 - Searching Chronic Obstructive Pulmonary Disease Onset N/A
Recruiting NCT02236039 - COPD Originates in Polluted Air N/A
Recruiting NCT02735954 - Colorado Marijuana Users Health Cohort
Recruiting NCT02223780 - Early Palliative Care for Patients With Severe and Very Severe COPD: a Randomised Study N/A
Recruiting NCT01892566 - Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV N/A