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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Copd

Intervention / Treatment
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* Drug: Formoterol/Budesonide 12/400 mcg Discair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formoterol/Budesonide 12/400 mcg Discair<br>Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair® | Drug: Formoterol/Budesonide 12/400 mcg Discair<br>* Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair®<br>* Other names: Forpack Discair® Inhalation Powder 12/400 mcg.;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Formoterol, Budesonide, Dry powder inhalation, Discair, COPD