COPDPhase 4COPDNCT03363503

Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Via Capsair vs Seretide Diskus 500 mcg Inhalation Powder in Patients With COPD

A Phase 4 study testing Salmeterol/Fluticasone Capsair® and Salmeterol/Fluticasone Diskus® in people with COPD, run by Neutec Ar-Ge San ve Tic A.Ş at 2 sites in Turkey (Türkiye).

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The aim of the current study is to compare the efficacy and safety of Salmeterol/Fluticasone 50/500 mcg Inhalation Powder treatment administered via Capsair twice daily and original product Seretide Diskus 500 mcg Inhalation Powder treatment twice daily in patients with moderate-severe COPD. Read more about this study

Who is it for?: Ages 40 to 100 years
Conditions the study is for: COPD
What is being tested?: Salmeterol/Fluticasone Capsair® and Salmeterol/Fluticasone Diskus®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 2 sitesTurkey (Türkiye)
Study dates: 13 Apr 2018to 13 Apr 2022
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 moderate-severe 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/ Forced Vital Capacity (FVC) <0.70, and FEV1 ≥30% and <80% of predicted normal value 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
Females patients with childbearing potential using effective birth control method
Patients whose medication unchanged within least 4 weeks

Show all 9Show fewer

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 long acting beta-2 agonists or corticosteroids
History of asthma or significant chronic respiratory diseases (e.g., interstitial lung diseases, significant bronchiectasis, etc.)
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
Use of immunosupresants or systemic corticosteroids within least 4 weeks
History of severe cardiac arrhythmia or myocardial infarction within less than 6 months
Significant or uncontrolled disease that may preclude participant from participating in the study

Show all 11Show fewer

Diognosis of cancer
History of lung volume reduction operation
Patients vaccinated with 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 and atopy

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

Akdeniz University Faculty of Medicine, Chest Diseases Department
Antalya
Republic of Turkey Ministry of Health Antalya Training and Research Hospital
Antalya

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Efficacy and Safety of Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Treatment Administered Via Capsair and Original Product Seretide Diskus 500 mcg Inhalation Powder Treatment in Patients With Moderate-severe Chronic Obstructive Pulmonary Disease (COPD)

Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits of 11-weeks study period.

Read the detailed description

Patients who met all the inclusion criteria will enter a 1-week run-in period with the length determine by the specific medication, during which their usual treatment will be stopped and they will receive salbutamol as required.

Following run-in period, patients will be randomly assigned to receive Salmeterol/Fluticasone 50/500 mcg as dry powder capsule for inhalation by Capsair or Salmeterol/Fluticasone 50/500 mcg as dry powder for inhalation by Diskus twice daily for 8-weeks treatment period.

Patients will be evaluated at 6 consecutive visits: baseline (enrollment), screening, treatment (treatment initiation, after 4 and 8 weeks of treatment) and after treatment (will carry out by telephone two weeks following the last dose of study medication).

Safety will be assessed through vital signs, adverse events, serious adverse events and all cause mortality.

Conditions: COPD
Being tested: Salmeterol/Fluticasone Capsair®, Salmeterol/Fluticasone Diskus®
Keywords: COPD, Salmeterol/Fluticasone, 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.

Salmeterol/Fluticasone Capsair®Drug
Also called Serair 50/500 mcg Capsair® Inhalation Powder
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks
Salmeterol/Fluticasone Diskus®Drug
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 8 weeks

Study groups in NCT03363503
Study group	Role	What they receive
Salmeterol/Fluticasone Capsair®	Experimental	Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks Receives: Drug: Salmeterol/Fluticasone Capsair®
Salmeterol/Fluticasone Diskus®	Active comparator	Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for 8 weeks Receives: Drug: Salmeterol/Fluticasone Diskus®

What is being measured

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

Mean maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1)
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Measured: 8-weeks treatment period after randomization
Mean percentage (%) change from baseline in
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Measured: 8-weeks treatment period after randomization
Comparison of FEV1 values at pre-dose and 2 hours post-dose
Spirometric measurement will be performed at pre-dose and 2 hours post-dose
Measured: 8-weeks treatment period after randomization
FEV1 (AUC0-12) response [AUC: area under the curve; response defined as change from baseline]
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Measured: 8-weeks treatment period after randomization
FVC (AUC0-12) response
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Measured: 8-weeks treatment period after randomization
FEV1 (AUC12-24) response
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Measured: 8-weeks treatment period after randomization
FVC (AUC12-24) response
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Measured: 8-weeks treatment period after randomization
FEV1 (AUC0-24) response
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Measured: 8-weeks treatment period after randomization
FVC (AUC0-24) response
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Measured: 8-weeks treatment period after randomization

Secondary outcomes (6)

Mean change from baseline in transition dyspnea index (TDI) after 8-weeks treatment
Transition Dyspnea Index (TDI), a measure of the degree of breathlessness, captures changes from baseline. Baseline Dyspnea Index (BDI) score is based on three domains: functional impairment, magnitude of task and magnitude of effort. BDI will be measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best).
Measured: 8-weeks treatment period after randomization
Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) after 8-weeks treatment
SGRQ is a 51-item health related quality of life questionnaire and it consists of three sections; Symptoms-measuring the frequency and severity of respiratory symptoms, Activity-measuring limitation of activities by breathlessness and activities that cause breathlessness and Impacts-measuring disturbances in social and psychological functioning due to airway disease. It will be performed to evaluate quality of life of the patients by comparing pre-treatment and post-treatment values. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
Measured: 8-weeks treatment period after randomization
Mean change from baseline in symptom severity and frequency (mean change from baseline in CAT score)
The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. It contains 8 questions regarding symptoms with scoring rage of zero to 40 (It will be completed using a 6 point scale).
Measured: 8-weeks treatment period after randomization
Frequency of rescue medicine (salbutamol) used
Patients will use a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.
Measured: 8-weeks treatment period after randomization
Time to onset of bronchodilator effect and maximum effect
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Measured: 8-weeks treatment period after randomization
Adverse events, serious adverse events and all cause mortality.
Safety will be assessed through the vital signs, number of adverse events, serious adverse events and all cause mortality.
Measured: 10 weeks after randomization

Timeline

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

13 Apr 201813 Apr 2022

First posted6 Dec 2017
Study start13 Apr 2018
Primary completion13 Apr 2022
Study completion13 Apr 2022

Why it stopped: Adequate number of patients could not be reached in the relevant centers.

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: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03363503
Sponsor's protocol ID: NEU-11.15
Acronym: COPD
Status last verified: May 2022
First submitted: 17 Nov 2017
Last updated: 20 May 2022
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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Study at a glance

From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Efficacy and Safety of Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Treatment Administered Via Capsair and Original Product Seretide Diskus 500 mcg Inhalation Powder Treatment in Patients With Moderate-severe Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT03363503
Acronym / sponsor ID: COPD / NEU-11.15
Conditions: COPD
Keywords: COPD, Salmeterol/Fluticasone, Discair, Diskus, Spirometry
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Adequate number of patients could not be reached in the relevant centers.
Enrolment: 64 participants (actual)
Lead sponsor: Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
Study start: 13 Apr 2018 (actual)
Primary completion: 13 Apr 2022 (actual)
Study completion: 13 Apr 2022 (actual)
First posted: 6 Dec 2017 (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

Safety will be assessed through vital signs, adverse events, serious adverse events and all cause mortality.

Study design

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

Arm	Type	Receives
Salmeterol/Fluticasone Capsair®	Experimental	Drug: Salmeterol/Fluticasone Capsair®Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks
Salmeterol/Fluticasone Diskus®	Active comparator	Drug: Salmeterol/Fluticasone Diskus®Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for 8 weeks

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 moderate-severe 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/ Forced Vital Capacity (FVC) <0.70, and FEV1 ≥30% and <80% of predicted normal value 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
Females patients with childbearing potential using effective birth control method

Key exclusion criteria (11 listed)

History of hypersensitivity to long acting beta-2 agonists or corticosteroids
History of asthma or significant chronic respiratory diseases (e.g., interstitial lung diseases, significant bronchiectasis, etc.)
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
Use of immunosupresants or systemic corticosteroids within least 4 weeks
History of severe cardiac arrhythmia or myocardial infarction within less than 6 months

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
Salmeterol/Fluticasone Capsair®Also: Serair 50/500 mcg Capsair® Inhalation PowderSalmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks	Drug	Salmeterol/Fluticasone Capsair®
Salmeterol/Fluticasone Diskus®Also: Seretide Diskus® 500 mcg Inhalation PowderSalmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for 8 weeks	Drug	Salmeterol/Fluticasone Diskus®

Primary outcome

Mean maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1)
Time frame: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Mean percentage (%) change from baseline in
Time frame: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Comparison of FEV1 values at pre-dose and 2 hours post-dose
Time frame: 8-weeks treatment period after randomization
Spirometric measurement will be performed at pre-dose and 2 hours post-dose
FEV1 (AUC0-12) response [AUC: area under the curve; response defined as change from baseline]
Time frame: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FVC (AUC0-12) response
Time frame: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FEV1 (AUC12-24) response
Time frame: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FVC (AUC12-24) response
Time frame: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FEV1 (AUC0-24) response
Time frame: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FVC (AUC0-24) response
Time frame: 8-weeks treatment period after randomization
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.

6 secondary outcomes

Mean change from baseline in transition dyspnea index (TDI) after 8-weeks treatment
Time frame: 8-weeks treatment period after randomization
Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) after 8-weeks treatment
Time frame: 8-weeks treatment period after randomization
Mean change from baseline in symptom severity and frequency (mean change from baseline in CAT score)
Time frame: 8-weeks treatment period after randomization
Frequency of rescue medicine (salbutamol) used
Time frame: 8-weeks treatment period after randomization
Time to onset of bronchodilator effect and maximum effect
Time frame: 8-weeks treatment period after randomization
Adverse events, serious adverse events and all cause mortality.
Time frame: 10 weeks after randomization

Results and safety

The study was stopped early (reason given: Adequate number of patients could not be reached in the relevant centers.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.

Related trials for COPD

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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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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?

A Phase 4 study testing Salmeterol/Fluticasone Capsair® and Salmeterol/Fluticasone Diskus® in people with COPD, run by Neutec Ar-Ge San ve Tic A.Ş at 2 sites 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 9 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: stopped early, as of the sponsor's last update on 20 May 2022. 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 was stopped early (reason given: Adequate number of patients could not be reached in the relevant centers.). Results are not available in the source record.

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 maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1) (time frame: 8-weeks treatment period after randomization). The study lists 9 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 NCT03363503.

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 20 May 2022.