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

NCT02988869 | Completed Phase 4

• 1 other identifier: NEU-22.12
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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 in patients with stable moderate to severe 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 \[24 hr\].

Conditions

COPD

Keywords

COPD; Tiotropium; Formoterol

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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)

  Predose and up to 24 hours postdose

Study Arms (3)

Tiotropium/Formoterol

EXPERIMENTAL

Tiotropium/Formoterol 18/12 mcg Inhalation Powder (1 puff) once daily via Discair®

Drug: Tiotropium/Formoterol

Tiotropium

ACTIVE COMPARATOR

Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler

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

Drug: Formoterol; Drug: Tiotropium

Interventions

Tiotropium/Formoterol DRUG

Tiotropium/Formoterol 18/12 mcg Inhalation Powder (1 puff) once daily via Discair®

Also known as: TRITON 18/12 mcg Discair Inhalation Powder

Tiotropium/Formoterol

Tiotropium DRUG

Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler

Also known as: SPIRIVA 18 mcg Inhalation Powder

Tiotropium

Formoterol DRUG

Formoterol 12 mcg Inhalation Powder (1 puff) twice daily via Aerolizer

Also known as: FORADIL 12 mcg Inhalation Powder

Tiotropium + Formoterol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Neutec Ar-Ge San ve Tic A.Ş: lead

Study Sites (1)

Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, 34020, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 31397184 RESULT

• 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.

  PMID: 32270722 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; Formoterol Fumarate; Neptune

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines; Planets; Solar System; Astronomical Objects; Astronomical Phenomena; Physical Phenomena

Study Officials

• Pinar Yildiz, Professor Doctor

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

  PRINCIPAL INVESTIGATOR

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: October 6, 2016
• First Posted: December 9, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: June 16, 2020

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)