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

N

Neutec Ar-Ge San ve Tic

Status and phase

Completed
Phase 4

Conditions

Copd

Treatments

Drug: Formoterol/Budesonide 12/400 mcg Discair

Study type

Interventional

Funder types

Industry

Identifiers

NCT03028701
NEU-20.13

Details and patient eligibility

About

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).

Full 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).

Enrollment

33 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

Formoterol/Budesonide 12/400 mcg Discair
Experimental group
Description:
Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair®
Treatment:
Drug: Formoterol/Budesonide 12/400 mcg Discair

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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