Clinical trial NCT03028701: Assessment of Bronchodilator Efficacy of Formoterol/Budesonide 12/400 mcg Via Discair in COPD
Official title: Assessment of Bronchodilator Efficacy of Formoterol/Budesonide 12/400 mcg Via Discair in Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Copd
Keywords: Formoterol
Budesonide
Dry powder inhalation
Discair
COPD
Lead sponsor: Neutec Ar-Ge San ve Tic A.Ş
Sponsor class: INDUSTRY
First posted: 2017-01-23
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Mean max improvement (ml) from baseline in FEV1 over a period of 12 h.
timeFrame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
measure: The time to onset of max improvement from baseline in FEV1.
timeFrame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
Secondary outcomes:
measure: Mean absolute change (ml) from baseline in FEV1 over a period of 12 h (over spirometric measurement period).
timeFrame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
measure: Mean absolute change (ml) from baseline in FVC over a period of 12 h (over spirometric measurement period).
timeFrame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
measure: Mean % change from baseline in FEV1 over a period of 12 h (over spirometric measurement period).
timeFrame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
measure: Mean % change from baseline in FVC over a period of 12 h (over spirometric measurement period).
timeFrame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
measure: FEV1 (AUC0-12) response
timeFrame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
measure: FVC (AUC0-12) response
timeFrame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
measure: Evaluation of safety
timeFrame: Predose and up to 12 hours postdose
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Study officials:
affiliation: Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital Istanbul, Turkey, 34020
name: Pınar Yıldız, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.