Tiotropium/Formoterol Via Discair® vs Tiotropium Monotherapy or Tiotropium + Formoterol Free Combination Treatment
NCT ID: NCT02988869
Last Updated: 2020-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
84 participants
INTERVENTIONAL
2016-08-31
2017-08-31
Brief Summary
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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 \[24 hr\].
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Detailed Description
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Patients will be randomly assigned to receive Tiotropium/Formoterol combination as dry powder for inhalation by Discair® (test inhaler, n = 29) or Tiotropium as dry powder capsule for inhalation by HandiHaler or tiotropium dry powder capsule for inhalation by HandiHaler + formoterol as dry powder capsule for inhalation by Aerolizer. Patients will be evaluated at 4 consecutive visits: baseline (enrollment), screening, treatment, and 24h after treatment.
For newly diagnosed and formerly diagnosed patients who are not on COPD medication, the screening visit will be performed on the day of enrollment. For formerly diagnosed patients 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.
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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tiotropium/Formoterol
Tiotropium/Formoterol 18/12 mcg Inhalation Powder (1 puff) once daily via Discair®
Tiotropium/Formoterol
Tiotropium/Formoterol 18/12 mcg Inhalation Powder (1 puff) once daily via Discair®
Tiotropium
Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler
Tiotropium
Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler
Tiotropium + Formoterol
Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler + Formoterol 12 mcg Inhalation Powder (1 puff) twice daily via Aerolizer
Formoterol
Formoterol 12 mcg Inhalation Powder (1 puff) twice daily via Aerolizer
Tiotropium
Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler
Interventions
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Tiotropium/Formoterol
Tiotropium/Formoterol 18/12 mcg Inhalation Powder (1 puff) once daily via Discair®
Tiotropium
Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler
Formoterol
Formoterol 12 mcg Inhalation Powder (1 puff) twice daily via Aerolizer
Tiotropium
Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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Neutec Ar-Ge San ve Tic A.Ş
INDUSTRY
Responsible Party
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Principal Investigators
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Pinar Yildiz, Professor Doctor
Role: PRINCIPAL_INVESTIGATOR
Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital-Turkey
Locations
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Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
Other Identifiers
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NEU-22.12
Identifier Type: -
Identifier Source: org_study_id
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