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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].
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.
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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium/Formoterol | Experimental | Tiotropium/Formoterol 18/12 mcg Inhalation Powder (1 puff) once daily via Discair® |
|
| Tiotropium | Active Comparator | Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium/Formoterol | Drug | Tiotropium/Formoterol 18/12 mcg Inhalation Powder (1 puff) once daily via Discair® |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The time to onset of bronchodilator effect | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pinar Yildiz, Professor Doctor | Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital-Turkey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital | Istanbul | 34020 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31397184 | Result | 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. | |
| 32270722 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| D000068759 | Formoterol Fumarate |
| D018541 | Neptune |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Tiotropium | Drug | Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler |
|
|
| Formoterol | Drug | Formoterol 12 mcg Inhalation Powder (1 puff) twice daily via Aerolizer |
|
|
| Tiotropium | Drug | Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler |
|
|
| 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) |
| The time to onset of maximum effect | 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) |
| Evaluation of safety (Physical examination, numbers of adverse reactions and abnormal laboratory values related to treatment) | Predose and up to 24 hours postdose |
| 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D016083 | Planets |
| D016082 | Solar System |
| D055587 | Astronomical Objects |
| D055580 | Astronomical Phenomena |
| D055585 | Physical Phenomena |