NCT03395002

Brief 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 with stable moderate to severe 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2018

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 22, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

June 12, 2020

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

December 7, 2017

Last Update Submit

June 11, 2020

Conditions

COPD

Keywords

TiotropiumSalmeterolFluticasoneCOPDBronchodilator effectDiscairDiskusSpirometry

Outcome Measures

Primary Outcomes (12)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    48 hrs

Secondary Outcomes (3)

  • The time to onset of bronchodilator effect

    48 hrs

  • The time to onset of maximum effect

    48 hrs

  • Evaluation of safety of study drug

    48 hrs

Study Arms (2)

Tiotropium/Salmeterol/Fluticasone

EXPERIMENTAL

Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Discair®

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®

Drug: Tiotropium 18 mcg Inhalation PowderDrug: Salmeterol/Fluticasone 50/500 mcg Inhalation Powder

Interventions

Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation PowderDRUG

Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder (1 puff) twice daily via Discair® for two days.

Also known as: Saltif 9/50/500 mcg Inhalation Powder
Tiotropium/Salmeterol/Fluticasone
Tiotropium 18 mcg Inhalation PowderDRUG

Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler® for two days.

Also known as: Spiriva 18 mcg Inhalation Powder
Tiotropium + Salmeterol/Fluticasone
Salmeterol/Fluticasone 50/500 mcg Inhalation PowderDRUG

Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for two days

Also known as: Seretide Diskus® 500 mcg Inhalation Powder
Tiotropium + Salmeterol/Fluticasone

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cukurova University Faculty of Medicine, Chest Diseases Department

Adana, Turkey (Türkiye)

Location

Health Sciences University, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium BromideSalmeterol XinafoateFluticasone

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingAlbuterolEthanolaminesAmino AlcoholsAlcoholsAminesPhenethylaminesEthylaminesAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

January 9, 2018

Study Start

March 22, 2018

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

June 12, 2020

Record last verified: 2019-01

Locations

TU(2)