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

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

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).

Study Overview

• Status: Completed
• Conditions: Copd
• Intervention / Treatment: Drug: Formoterol/Budesonide 12/400 mcg Discair

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).

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34020
    • Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged ≥40 years with newly or formerly diagnosed moderate to severe COPD (Patients with postbronchodilator FEV1/FVC ratio <0.70, and FEV1 <80% of predicted normal. Patients have chronic cough or chronic productive cough with breathlessness even walking slowly along flat ground.) Current smokers or exsmokers with a smoking history of at least 10 pack-years
• Patients who have no exacerbation within last 4 weeks
• Females patients with childbearing potential using effective birth control method
• Patients who has a capability of communicate with investigator
• Patients who accept to comply with the requirements of the protocol
• Patients who signed written informed consent prior to participation

Exclusion Criteria:

• Patients who have history of hypersensitivity to drugs contains long-acting beta2-agonist or corticosteroids
• Patients who have abnormal blood glucose level ((≥140 mg/dl)
• Patients who have unregulated diabetes mellitus
• Patients who have a serum potassium level of ≤3.5 mEq/L or >5.5mEq/L
• Patients who have asthma
• Patients who have a history of myocardial infarction, severe hearth failure, acute ischemic coroner disease or severe cardiac arrhythmia requiring treatment within least 6 weeks
• Patients who have lung cancer
• Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period.
• Patients who had COPD exacerbation or lower respiratory track infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to screening visit or during run-in period.
• Women who are pregnant or nursing
• History of allergic rhinitis or atopy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Formoterol/Budesonide 12/400 mcg Discair; Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair®	Drug: Formoterol/Budesonide 12/400 mcg Discair; Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair®; Other Names: Forpack Discair® Inhalation Powder 12/400 mcg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean max improvement (ml) from baseline in FEV1 over a period of 12 h.	Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.	Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
The time to onset of max improvement from baseline in FEV1.	Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.	Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean absolute change (ml) from baseline in FEV1 over a period of 12 h (over spirometric measurement period).	Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.	Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
Mean absolute change (ml) from baseline in FVC over a period of 12 h (over spirometric measurement period).	Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.	Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
Mean % change from baseline in FEV1 over a period of 12 h (over spirometric measurement period).	Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.	Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
Mean % change from baseline in FVC over a period of 12 h (over spirometric measurement period).	Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.	Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
FEV1 (AUC0-12) response	Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.	Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
FVC (AUC0-12) response	Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.	Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
Evaluation of safety	(Physical examination, numbers of adverse reactions and abnormal laboratory values related	Predose and up to 12 hours postdose

Collaborators and Investigators

• Sponsor: Neutec Ar-Ge San ve Tic A.Ş
• Investigators: Principal Investigator: Pınar Yıldız, Assoc. Prof., Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital Istanbul, Turkey, 34020

Publications and helpful links

General Publications

• Yildiz P, Bayraktaroglu M, Gorgun D, Yuksel K. Bronchodilator Efficacy of a Single-Dose 12/400-microg Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered by Discair(R) in Adult Patients with Moderate-to-Severe Stable COPD: Open-Label, Single-Arm, Phase IV Trial. Clin Drug Investig. 2019 Oct;39(10):991-1001. doi: 10.1007/s40261-019-00828-y.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: COPD; Formoterol; Budesonide; Dry powder inhalation; Discair
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Budesonide; Formoterol Fumarate
• Other Study ID Numbers: NEU-20.13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No