CopdPhase 4COPDNCT03028701
Assessment of Bronchodilator Efficacy of Formoterol/Budesonide 12/400 mcg Via Discair in COPD
A Phase 4 study testing Formoterol/Budesonide 12/400 mcg Discair in people with Copd, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Copd
- What is being tested?
- Formoterol/Budesonide 12/400 mcg Discair
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2015to Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul, 34020
About this study
Official title: Assessment of Bronchodilator Efficacy of Formoterol/Budesonide 12/400 mcg Via Discair in Chronic Obstructive Pulmonary Disease (COPD)
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).
- Conditions
- Copd
- Being tested
- Formoterol/Budesonide 12/400 mcg Discair
- Keywords
- Formoterol, Budesonide, Dry powder inhalation, Discair, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formoterol/Budesonide 12/400 mcg DiscairDrug
Also called Forpack Discair® Inhalation Powder 12/400 mcg.
Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair®
| Study group | Role | What they receive |
|---|---|---|
| Formoterol/Budesonide 12/400 mcg Discair | Experimental | Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair® Receives: Drug: Formoterol/Budesonide 12/400 mcg Discair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Predose and up to 12 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startSep 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.Ş
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pınar Yıldız, Assoc. Prof., Principal investigator, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital Istanbul, Turkey, 34020
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028701
- Sponsor's protocol ID
- NEU-20.13
- Acronym
- COPD
- Status last verified
- Jan 2017
- First submitted
- 18 Jan 2017
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bronchodilator Efficacy of Formoterol/Budesonide 12/400 mcg Via Discair in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03028701
- Acronym / sponsor ID
- COPD / NEU-20.13
- Conditions
- Copd
- Keywords
- Formoterol, Budesonide, Dry powder inhalation, Discair, COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Formoterol/Budesonide 12/400 mcg Discair | Experimental | Drug: Formoterol/Budesonide 12/400 mcg DiscairFormoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair® |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formoterol/Budesonide 12/400 mcg DiscairAlso: Forpack Discair® Inhalation Powder 12/400 mcg.Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair® | Drug | Formoterol/Budesonide 12/400 mcg Discair |
Primary outcome
Mean max improvement (ml) from baseline in FEV1 over a period of 12 h.
Time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
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.
The time to onset of max improvement from baseline in FEV1.
Time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
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.
7 secondary outcomes
Mean absolute change (ml) from baseline in FEV1 over a period of 12 h (over spirometric measurement period).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
FEV1 (AUC0-12) response
Time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
FVC (AUC0-12) response
Time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
Evaluation of safety
Time frame: Predose and up to 12 hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Results publication: PubMed 31332649Yildiz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pınar Yıldız, Assoc. Prof. principal investigator
Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital Istanbul, Turkey, 34020
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Formoterol/Budesonide 12/400 mcg Discair in people with Copd, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean max improvement (ml) from baseline in FEV1 over a period of 12 h. (time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03028701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.