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

NCT03028701 | Completed Phase 4

• 1 other identifier: NEU-20.13
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Copd

Keywords

Formoterol; Budesonide; Dry powder inhalation; Discair; COPD

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Mean absolute change (ml) from baseline in FEV1 over a period of 12 h (over spirometric measurement period).

  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).

  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).

  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).

  Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)

• FEV1 (AUC0-12) response

  Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)

Study Arms (1)

Formoterol/Budesonide 12/400 mcg Discair

EXPERIMENTAL

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

Drug: Formoterol/Budesonide 12/400 mcg Discair

Interventions

Formoterol/Budesonide 12/400 mcg Discair DRUG

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

Also known as: Forpack Discair® Inhalation Powder 12/400 mcg.

Formoterol/Budesonide 12/400 mcg Discair

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neutec Ar-Ge San ve Tic A.Ş: lead

Study Sites (1)

Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, 34020, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 31332649 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate; Budesonide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Pınar Yıldız, Assoc. Prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 23, 2017
• Study Start: September 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 16, 2020

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)