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Completed

NCT Number: NCT03395002

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cukurova University Faculty of Medicine, Chest Diseases Department, Adana, Turkey (Türkiye)

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About this study

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.

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Drug

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

Other names: Saltif 9/50/500 mcg Inhalation Powder

Tiotropium 18 mcg Inhalation Powder

Drug

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

Other names: Spiriva 18 mcg Inhalation Powder

Salmeterol/Fluticasone 50/500 mcg Inhalation Powder

Drug

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

Other names: Seretide Diskus® 500 mcg Inhalation Powder

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Secondary outcomes

  1. The time to onset of bronchodilator effect

    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.

  2. The time to onset of maximum effect

    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. Evaluation of safety of study drug

    Time frame: 48 hrs

    Number of participants with treatment-related adverse events and/or abnormal laboratory values.

Sponsors and collaborators

Lead sponsor

Neutec Ar-Ge San ve Tic A.Ş

Industry

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 9, 2018
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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