COPDPhase 4NCT02988869

Tiotropium/Formoterol Via Discair® vs Tiotropium Monotherapy or Tiotropium + Formoterol Free Combination Treatment

A Phase 4 study testing Tiotropium/Formoterol, Tiotropium and Formoterol in people with COPD, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The overall objective is to asses the bronchodilator effect of once daily Tiotropium/Formoterol combination delivered via Discair® by comparing Tiotropium (q.d.) monotherapy delivered via Handihaler and tiotropium (q.d.) delivered via Handihaler + formoterol (b.i.d) delivered via Aerolizer free combination treatment… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
What is being tested?: Tiotropium/Formoterol, Tiotropium and Formoterol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Aug 2016to Aug 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 COPD diagnosis according to the current GOLD (The Global Initiative for Chronic Obstructive Lung Disease) strategy.
Patients who have symptomatic stable moderate to severe COPD diagnosis with post-bronchodilator FEV1/FVC ratio <0.70, and FEV1 <80% of predicted normal at screening visit.
Current smokers or ex-smokers with a smoking history of at least 10 pack-years
Patients who have no exacerbation within last 4 weeks
Female patients with childbearing potential using effective birth control method
Patients who signed written informed consent prior to participation
Patients who accept to comply with the requirements of the protocol
Patients who have a capability of communicate with investigator

Who cannot join

History of hypersensitivity to drugs contains anticholinergics, beta-adrenergic, lactose
Diagnosis of asthma
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.
Patients who have a history of myocardial infarction, hearth failure, acute ischemic coroner disease or severe cardiac arrhythmia requiring treatment within least 6 weeks
Patients who have lung cancer

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Patients with active tuberculosis
Patients who use oxygen therapy
Patients who have common interstitial lung diseases like cystic fibrosis, bronchiolitis obliterans
Patients with serious liver or renal disease that leads to organ failure
Women who are pregnant or nursing
History of allergic rhinitis and atopy
Known symptomatic prostatic hypertrophy requiring drug therapy or operation
Patients with narrow-angle glaucoma requiring drug therapy

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

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Bronchodilator Efficacy of Tiotropium/Formoterol Combination Treatment Administered (qd) Via Discair® With Tiotropium (qd) Monotherapy or Tiotropium (qd) + Formoterol (Bid) Free Combination Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Spirometric measurements (FEV1, FVC) will be performed for a period of 24 h at 12 different times: pre-treatment (15 min prior to the first dose) and post-treatment (30. min, 60 min [1 hr], 120 min [2 hr], 180 min [3 hr], 240 min [4 hr], 360 min [6 hr], 480 min [8 hr], 600 min [10 hr], 720 min [12 hr], 840 min [14 hr],1440 min [24 hr].

Read the detailed description

Patients will be randomly assigned to receive Tiotropium/Formoterol combination as dry powder for inhalation by Discair® (test inhaler, n = 29) or Tiotropium as dry powder capsule for inhalation by HandiHaler or tiotropium dry powder capsule for inhalation by HandiHaler + formoterol as dry powder capsule for inhalation by Aerolizer. Patients will be evaluated at 4 consecutive visits: baseline (enrollment), screening, treatment, and 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.

Conditions: COPD
Being tested: Tiotropium/Formoterol, Tiotropium, Formoterol
Keywords: COPD, Tiotropium, Formoterol
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.

Tiotropium/FormoterolDrug
Also called TRITON 18/12 mcg Discair Inhalation Powder
Tiotropium/Formoterol 18/12 mcg Inhalation Powder (1 puff) once daily via Discair®
TiotropiumDrug
Also called SPIRIVA 18 mcg Inhalation Powder
Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler
FormoterolDrug
Also called FORADIL 12 mcg Inhalation Powder
Formoterol 12 mcg Inhalation Powder (1 puff) twice daily via Aerolizer
TiotropiumDrug
Also called SPIRIVA Inhalation Powder
Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler

Study groups in NCT02988869
Study group	Role	What they receive
Tiotropium/Formoterol	Experimental	Tiotropium/Formoterol 18/12 mcg Inhalation Powder (1 puff) once daily via Discair® Receives: Drug: Tiotropium/Formoterol
Tiotropium	Active comparator	Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler Receives: Drug: Tiotropium
Tiotropium + Formoterol	Active comparator	Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler + Formoterol 12 mcg Inhalation Powder (1 puff) twice daily via Aerolizer Receives: Drug: Formoterol; Drug: Tiotropium

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean max change (ml) from baseline in FEV1 over a period of 24 h.
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Measured: Pre-treatment (10 minutes prior to the first dose of randomized study medication) and post-treatment (Day 1)
Mean % change from baseline in FEV1 over a period of 24 h.
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Measured: Pre-treatment (10 minutes prior to the first dose of randomized study medication) and post-treatment (Day 1)
Mean max change (ml) from baseline in FVC over a period of 24 h.
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Measured: Pre-treatment (10 minutes prior to the first dose of randomized study medication) and post-treatment (Day 1)
Mean % change from baseline in FVC over a period of 24 h.
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Measured: Pre-treatment (10 minutes prior to the first dose of randomized study medication) and post-treatment (Day 1)
FEV1 (AUC0-12) response
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Measured: From pre-treatment (10 minutes prior to the first dose of randomized study medication) to 12 hours post-treatment (Day 1)
FVC (AUC0-12) response
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Measured: From pre-treatment (10 minutes prior to the first dose of randomized study medication) to 12 hours post-treatment (Day 1)
FEV1 (AUC0-24) response
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Measured: From pre-treatment (10 minutes prior to the first dose of randomized study medication) to 24 hours post-treatment (Day 1)
FVC (AUC0-24) response
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Measured: From pre-treatment (10 minutes prior to the first dose of randomized study medication) to 24 hours post-treatment (Day 1)
FEV1 (AUC12-24) response
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Measured: From pre-treatment (10 minutes prior to the first dose of randomized study medication) to 24 hours post-treatment (Day 1)
FVC (AUC12-24) response
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Measured: From pre-treatment (10 minutes prior to the first dose of randomized study medication) to 24 hours post-treatment (Day 1)

Secondary outcomes (3)

The time to onset of bronchodilator effect
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Measured: Pre-treatment (10 minutes prior to the first dose of randomized study medication) and post-treatment (Day 1)
The time to onset of maximum effect
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Measured: Pre-treatment (10 minutes prior to the first dose of randomized study medication) and post-treatment (Day 1)
Evaluation of safety (Physical examination, numbers of adverse reactions and abnormal laboratory values related to treatment)
Measured: Predose and up to 24 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Aug 2017

First posted9 Dec 2016 (estimated)
Study startAug 2016
Primary completionAug 2017
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02988869
Sponsor's protocol ID: NEU-22.12
Status last verified: Dec 2017
First submitted: 6 Oct 2016
Last updated: 16 Jun 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Yildiz BP, Bayraktaroglu M, Gunen H. Bronchodilator efficacy of tiotropium/formoterol (18/12 microg once daily via a Discair inhaler), tiotropium alone (18 microg by Handihaler) or combined with formoterol (12 microg twice daily by Aerolizer) in adults with moderate-to-severe stable COPD. Curr Med Res Opin. 2019 Dec;35(12):2187-2196. doi: 10.1080/03007995.2019.1654722. Epub 2019 Sep 16.
PubMed 31397184
Yildiz BP, Bayraktaroglu M, Gunen H. Reply: Re: Yildiz BP, Bayraktaroglu M, Gunen H. Bronchodilator efficacy of tiotropium/formoterol (18/12 mug once daily via a discair inhaler), tiotropium alone (18 mug by handihaler) or combined with formoterol (12 mug twice daily by aerolizer) in adults with moderate-to-severe stable COPD. Curr Med Res Opin. 2019;35(12):2187-2196. Curr Med Res Opin. 2020 Jun;36(6):1061-1062. doi: 10.1080/03007995.2020.1754187. Epub 2020 Apr 29. No abstract available.
PubMed 32270722

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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: Comparison of Bronchodilator Efficacy of Tiotropium/Formoterol Combination Treatment Administered (qd) Via Discair® With Tiotropium (qd) Monotherapy or Tiotropium (qd) + Formoterol (Bid) Free Combination Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT02988869
Acronym / sponsor ID: NEU-22.12
Conditions: COPD
Keywords: COPD, Tiotropium, Formoterol
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
Study start: Aug 2016 (actual)
Primary completion: Aug 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 9 Dec 2016 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Tiotropium/Formoterol	Experimental	Drug: Tiotropium/FormoterolTiotropium/Formoterol 18/12 mcg Inhalation Powder (1 puff) once daily via Discair®
Tiotropium	Active comparator	Drug: TiotropiumTiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler
Tiotropium + Formoterol	Active comparator	Drug: Formoterol, Drug: TiotropiumTiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler + Formoterol 12 mcg Inhalation Powder (1 puff) twice daily via Aerolizer

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients aged ≥40 years with COPD diagnosis according to the current GOLD (The Global Initiative for Chronic Obstructive Lung Disease) strategy.
Patients who have symptomatic stable moderate to severe COPD diagnosis with post-bronchodilator FEV1/FVC ratio <0.70, and FEV1 <80% of predicted normal at screening visit.
Current smokers or ex-smokers with a smoking history of at least 10 pack-years
Patients who have no exacerbation within last 4 weeks
Female patients with childbearing potential using effective birth control method

Key exclusion criteria (14 listed)

History of hypersensitivity to drugs contains anticholinergics, beta-adrenergic, lactose
Diagnosis of asthma
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.
Patients who have a history of myocardial infarction, hearth failure, acute ischemic coroner disease or severe cardiac arrhythmia requiring treatment within least 6 weeks

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
Tiotropium/FormoterolAlso: TRITON 18/12 mcg Discair Inhalation PowderTiotropium/Formoterol 18/12 mcg Inhalation Powder (1 puff) once daily via Discair®	Drug	Tiotropium/Formoterol
TiotropiumAlso: SPIRIVA 18 mcg Inhalation PowderTiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler	Drug	Tiotropium
FormoterolAlso: FORADIL 12 mcg Inhalation PowderFormoterol 12 mcg Inhalation Powder (1 puff) twice daily via Aerolizer	Drug	Tiotropium + Formoterol
TiotropiumAlso: SPIRIVA Inhalation PowderTiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler	Drug	Tiotropium + Formoterol

Primary outcome

Mean max change (ml) from baseline in FEV1 over a period of 24 h.
Time frame: Pre-treatment (10 minutes prior to the first dose of randomized study medication) and post-treatment (Day 1)
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Mean % change from baseline in FEV1 over a period of 24 h.
Time frame: Pre-treatment (10 minutes prior to the first dose of randomized study medication) and post-treatment (Day 1)
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Mean max change (ml) from baseline in FVC over a period of 24 h.
Time frame: Pre-treatment (10 minutes prior to the first dose of randomized study medication) and post-treatment (Day 1)
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
Mean % change from baseline in FVC over a period of 24 h.
Time frame: Pre-treatment (10 minutes prior to the first dose of randomized study medication) and post-treatment (Day 1)
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
FEV1 (AUC0-12) response
Time frame: From pre-treatment (10 minutes prior to the first dose of randomized study medication) to 12 hours post-treatment (Day 1)
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
FVC (AUC0-12) response
Time frame: From pre-treatment (10 minutes prior to the first dose of randomized study medication) to 12 hours post-treatment (Day 1)
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
FEV1 (AUC0-24) response
Time frame: From pre-treatment (10 minutes prior to the first dose of randomized study medication) to 24 hours post-treatment (Day 1)
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
FVC (AUC0-24) response
Time frame: From pre-treatment (10 minutes prior to the first dose of randomized study medication) to 24 hours post-treatment (Day 1)
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
FEV1 (AUC12-24) response
Time frame: From pre-treatment (10 minutes prior to the first dose of randomized study medication) to 24 hours post-treatment (Day 1)
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.
FVC (AUC12-24) response
Time frame: From pre-treatment (10 minutes prior to the first dose of randomized study medication) to 24 hours post-treatment (Day 1)
Spirometric measurements will be made at 10 minutes prior to the first dose of randomized study medication and and post-treatment at 30. min, 60 min, 120 min, 180 min, 240 min, 360 min, 480 min, 600 min, 720 min, 840 min, 1440 min.

3 secondary outcomes

The time to onset of bronchodilator effect
Time frame: Pre-treatment (10 minutes prior to the first dose of randomized study medication) and post-treatment (Day 1)
The time to onset of maximum effect
Time frame: Pre-treatment (10 minutes prior to the first dose of randomized study medication) and post-treatment (Day 1)
Evaluation of safety (Physical examination, numbers of adverse reactions and abnormal laboratory values related to treatment)
Time frame: Predose and up to 24 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 31397184Yildiz BP, Bayraktaroglu M, Gunen H. Bronchodilator efficacy of tiotropium/formoterol (18/12 microg once daily via a Discair inhaler), tiotropium alone (18 microg by Handihaler) or combined with formoterol (12 microg twice daily by Aerolizer) in adults with moderate-to-severe stable COPD. Curr Med Res Opin. 2019 Dec;35(12):2187-2196. doi: 10.1080/03007995.2019.1654722. Epub 2019 Sep 16.
Results publication: PubMed 32270722Yildiz BP, Bayraktaroglu M, Gunen H. Reply: Re: Yildiz BP, Bayraktaroglu M, Gunen H. Bronchodilator efficacy of tiotropium/formoterol (18/12 mug once daily via a discair inhaler), tiotropium alone (18 mug by handihaler) or combined with formoterol (12 mug twice daily by aerolizer) in adults with moderate-to-severe stable COPD. Curr Med Res Opin. 2019;35(12):2187-2196. Curr Med Res Opin. 2020 Jun;36(6):1061-1062. doi: 10.1080/03007995.2020.1754187. Epub 2020 Apr 29. No abstract available.
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.

Pinar Yildiz, Professor Doctor principal investigator

Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital-Turkey

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 Tiotropium/Formoterol, Tiotropium and Formoterol 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 8 inclusion and 14 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 change (ml) from baseline in FEV1 over a period of 24 h. (time frame: Pre-treatment (10 minutes prior to the first dose of randomized study medication) and post-treatment (Day 1)). The study lists 10 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 NCT02988869, which also lists 2 linked publications.

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; AzTrials last refreshed its copy on 8 Nov 2026.