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

NCT ID: NCT03028701

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-03-31

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).

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Formoterol/Budesonide 12/400 mcg Discair

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

Group Type: EXPERIMENTAL

Formoterol/Budesonide 12/400 mcg Discair

Intervention Type: DRUG

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

Interventions

Formoterol/Budesonide 12/400 mcg Discair

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

Intervention Type: DRUG

Other Intervention Names

Forpack Discair® Inhalation Powder 12/400 mcg.

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neutec Ar-Ge San ve Tic A.Ş

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pınar Yıldız, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 31332649 (View on PubMed)

Other Identifiers

NEU-20.13

Identifier Type: -

Identifier Source: org_study_id