COPDPhase 4NCT03395002

Tiotropium/Salmeterol/Fluticasone Fixed Dose Combination Tratment Via Discair vs Tiotropium Via Handihaler + Salmeterol/Fluticasone Via Diskus Free Combination Treatment

A Phase 4 study testing Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder, Tiotropium 18 mcg Inhalation Powder and Salmeterol/Fluticasone 50/500 mcg Inhalation Powder in people with COPD, run by Neutec Ar-Ge San ve Tic A.Ş at 2 sites 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 Tiotropium/Salmeterol/Fluticasone combination delivered via Discair® twice daily as compared with original products Seretide Diskus 500 mcg Inhalation Powder twice daily and Spiriva 18 mcg Inhalation Powder once daily free combination treatment in patients… Read more about this study

Who is it for?: Ages 40 to 100 years
Conditions the study is for: COPD
What is being tested?: Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder, Tiotropium 18 mcg Inhalation Powder and Salmeterol/Fluticasone 50/500 mcg Inhalation Powder
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 2 sitesTurkey (Türkiye)
Study dates: 22 Mar 2018to 30 Apr 2020
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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients aged ≥40 years with COPD diagnosis according to the 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 value at screening visit.
Patients with a mMRC score ≥2
Current smokers or ex-smokers with a smoking history of at least 10 pack-years
Patients who have an exacerbation within least a year and no exacerbation within last 4 weeks
Females patients with childbearing potential using effective birth control method

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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

History of hypersensitivity to drugs contains long acting beta-2 agonists, corticosteroids, anticholinergics or lactose.
History of asthma or significant chronic respiratory diseases except COPD.
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 with serum potassium level ≤ 3.5 mEq/L or >5.5 mEq/L
Patients who used systemic corticosteroids or immunosupresants within 4 weeks prior to study onset
Patients who have a history of myocardial infarction, hearth failure, acute ischemic coroner disease or severe cardiac arrhythmia requiring treatment within least 6 weeks

Show all 12Show fewer

Patients who have lung cancer
Patients who had lung volume reduction operation
Patients who had live attenuated vaccines within 2 weeks prior to screening visit or during run-in period
Women patients who are pregnant or nursing
History of allergic rhinitis or atopy
Known symptomatic prostatic hypertrophy requiring drug therapy or operation

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

Cukurova University Faculty of Medicine, Chest Diseases Department
Adana
Health Sciences University, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Bronchodilator Efficacy of Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Combination Treatment Administered Via Discair® With Original Products Seretide Diskus 500 mcg Inhalation Powder Plus Spiriva 18 mcg Inhalation Powder Treatment in Patients With Moderate-severe Chronic Obstructive Pulmonary Disease (COPD)

Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

Read the detailed description

For formerly diagnosed patients who met all the inclusion criteria and 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.

Patients (following run-in period for formerly diagnosed patients) will be randomly assigned to receive Tiotropium/Salmeterol/Fluticasone fixed dose combination as dry powder inhalation delivered via Discair® twice daily or Seretide Diskus 500 mcg Inhalation Powder twice daily and Spiriva 18 mcg Inhalation Powder once daily free combination for 2-days treatment period.

Patients will be evaluated at 4 consecutive visits: baseline (enrollment), screening, treatment and after treatment.

Conditions: COPD
Being tested: Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder, Tiotropium 18 mcg Inhalation Powder, Salmeterol/Fluticasone 50/500 mcg Inhalation Powder
Keywords: Tiotropium, Salmeterol, Fluticasone, COPD, Bronchodilator effect, Discair, Diskus, Spirometry
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/Salmeterol/Fluticasone 9/50/500 mcg Inhalation PowderDrug
Also called Saltif 9/50/500 mcg Inhalation Powder
Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder (1 puff) twice daily via Discair® for two days.
Tiotropium 18 mcg Inhalation PowderDrug
Also called Spiriva 18 mcg Inhalation Powder
Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler® for two days.
Salmeterol/Fluticasone 50/500 mcg Inhalation PowderDrug
Also called Seretide Diskus® 500 mcg Inhalation Powder
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for two days

Study groups in NCT03395002
Study group	Role	What they receive
Tiotropium/Salmeterol/Fluticasone	Experimental	Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Discair® Receives: Drug: Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder
Tiotropium + Salmeterol/Fluticasone	Active comparator	Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler® + Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® Receives: Drug: Tiotropium 18 mcg Inhalation Powder; Drug: Salmeterol/Fluticasone 50/500 mcg Inhalation Powder

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 48 hrs.
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: 48 hrs
Mean % change from baseline in FEV1 over a period of 48 hrs.
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: 48 hrs
Mean max change (ml) from baseline in FVC over a period of 48 hrs.
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: 48 hrs
Mean % change from baseline in FVC over a period of 48 hrs.
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: 48 hrs
FEV1 (AUC0-12) response [AUC: area under the curve; response defined as change from baseline]
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: Day 1: 0-12 hrs
FVC (AUC0-12) response
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: Day 1: 0-12 hrs
FEV1 (AUC12-24) response
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: Day 1: 12-24 hrs
FVC (AUC12-24) response
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: Day 1: 12-24 hrs
FEV1 (AUC24-48) response
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: Day 2: 0-24 hrs
FVC (AUC24-48) response
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: Day 2: 0-24 hrs
FEV1 (AUC0-48) response
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: 48 hrs
FVC (AUC0-48) response
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: 48 hrs

Secondary outcomes (3)

The time to onset of bronchodilator effect
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: 48 hrs
The time to onset of maximum effect
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Measured: 48 hrs
Evaluation of safety of study drug
Number of participants with treatment-related adverse events and/or abnormal laboratory values.
Measured: 48 hrs

Timeline

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

22 Mar 201830 Apr 2020

First posted9 Jan 2018
Study start22 Mar 2018
Primary completion30 Apr 2020
Study completion30 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03395002
Sponsor's protocol ID: NEU-01.17
Status last verified: Jan 2019
First submitted: 7 Dec 2017
Last updated: 12 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Bronchodilator Efficacy of Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Combination Treatment Administered Via Discair® With Original Products Seretide Diskus 500 mcg Inhalation Powder Plus Spiriva 18 mcg Inhalation Powder Treatment in Patients With Moderate-severe Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT03395002
Acronym / sponsor ID: NEU-01.17
Conditions: COPD
Keywords: Tiotropium, Salmeterol, Fluticasone, COPD, Bronchodilator effect, Discair, Diskus, Spirometry
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
Study start: 22 Mar 2018 (actual)
Primary completion: 30 Apr 2020 (actual)
Study completion: 30 Apr 2020 (actual)
First posted: 9 Jan 2018 (actual)
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

Patients will be evaluated at 4 consecutive visits: baseline (enrollment), screening, treatment and after treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tiotropium/Salmeterol/Fluticasone	Experimental	Drug: Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation PowderTiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Discair®
Tiotropium + Salmeterol/Fluticasone	Active comparator	Drug: Tiotropium 18 mcg Inhalation Powder, Drug: Salmeterol/Fluticasone 50/500 mcg Inhalation PowderTiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler® + Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus®

Who may qualify

Ages: 40 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients aged ≥40 years with COPD diagnosis according to the 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 value at screening visit.
Patients with a mMRC score ≥2
Current smokers or ex-smokers with a smoking history of at least 10 pack-years
Patients who have an exacerbation within least a year and no exacerbation within last 4 weeks

Key exclusion criteria (12 listed)

History of hypersensitivity to drugs contains long acting beta-2 agonists, corticosteroids, anticholinergics or lactose.
History of asthma or significant chronic respiratory diseases except COPD.
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 with serum potassium level ≤ 3.5 mEq/L or >5.5 mEq/L
Patients who used systemic corticosteroids or immunosupresants within 4 weeks prior to study onset

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/Salmeterol/Fluticasone 9/50/500 mcg Inhalation PowderAlso: Saltif 9/50/500 mcg Inhalation PowderTiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder (1 puff) twice daily via Discair® for two days.	Drug	Tiotropium/Salmeterol/Fluticasone
Tiotropium 18 mcg Inhalation PowderAlso: Spiriva 18 mcg Inhalation PowderTiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler® for two days.	Drug	Tiotropium + Salmeterol/Fluticasone
Salmeterol/Fluticasone 50/500 mcg Inhalation PowderAlso: Seretide Diskus® 500 mcg Inhalation PowderSalmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for two days	Drug	Tiotropium + Salmeterol/Fluticasone

Primary outcome

Mean max change (ml) from baseline in FEV1 over a period of 48 hrs.
Time frame: 48 hrs
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Mean % change from baseline in FEV1 over a period of 48 hrs.
Time frame: 48 hrs
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Mean max change (ml) from baseline in FVC over a period of 48 hrs.
Time frame: 48 hrs
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
Mean % change from baseline in FVC over a period of 48 hrs.
Time frame: 48 hrs
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
FEV1 (AUC0-12) response [AUC: area under the curve; response defined as change from baseline]
Time frame: Day 1: 0-12 hrs
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
FVC (AUC0-12) response
Time frame: Day 1: 0-12 hrs
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
FEV1 (AUC12-24) response
Time frame: Day 1: 12-24 hrs
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
FVC (AUC12-24) response
Time frame: Day 1: 12-24 hrs
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
FEV1 (AUC24-48) response
Time frame: Day 2: 0-24 hrs
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
FVC (AUC24-48) response
Time frame: Day 2: 0-24 hrs
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
FEV1 (AUC0-48) response
Time frame: 48 hrs
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.
FVC (AUC0-48) response
Time frame: 48 hrs
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

3 secondary outcomes

The time to onset of bronchodilator effect
Time frame: 48 hrs
The time to onset of maximum effect
Time frame: 48 hrs
Evaluation of safety of study drug
Time frame: 48 hrs

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 12 Jun 2020.

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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 12 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 12 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 2 sites 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 48 hrs. (time frame: 48 hrs). The study lists 12 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 NCT03395002.

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 12 Jun 2020.