CClinicalTrials.gg
Sign In
CompletedNCT03028701COPDUpdated Jun 16, 2020

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

A Phase 4 interventional study of Formoterol/Budesonide 12/400 mcg Discair in Copd, sponsored by Neutec Ar-Ge San ve Tic A.Ş. Completed at 1 site in Turkey. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Neutec Ar-Ge San ve Tic A.Ş · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Sep 2015, registered Jan 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Copd

Keywords

  • Formoterol
  • Budesonide
  • Dry powder inhalation
  • Discair
  • COPD
03

In context

Lead sponsor

Neutec Ar-Ge San ve Tic A.Ş is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Formoterol/Budesonide 12/400 mcg Discair

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

    Drug: Formoterol/Budesonide 12/400 mcg Discair

Interventions

  • DrugFormoterol/Budesonide 12/400 mcg Discair

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

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. Evaluation of safety

    (Physical examination, numbers of adverse reactions and abnormal laboratory values related

    Time frame: Predose and up to 12 hours postdose

07

Study locations

1 site
  • Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
    Istanbul, 34020, Turkey
08

References and documents

Publications

  • 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. PubMed 31332649 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03028701
Lead sponsor
Neutec Ar-Ge San ve Tic A.Ş
Responsible party
Sponsor
First posted
Jan 23, 2017
Start date
Sep 2015
Primary completion
Mar 2017
Completion
Mar 2017
Last update
Jun 16, 2020

Study contacts

Pınar Yıldız, Assoc. Prof.
principal investigator · Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital Istanbul, Turkey, 34020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Neutec Ar-Ge San ve Tic A.Ş

Start the discussion