NCT03028701

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

Assessment of Bronchodilator Efficacy of Formoterol/Budesonide 12/400 mcg Via Discair in Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Neutec Ar-Ge San ve Tic A.Ş · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Copd

Interventions

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

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2017-01-23
• Last updated: 2020-06-16

Locations

1 site across 1 country: Turkey (Türkiye)