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The purpose of this study is to investigate heart rate lowering efficacy and respiratory safety of ivabradine in patients with asthma and COPD.
In this double blind, placebo-controlled, crossover study, 20 asthmatics and 20 COPD patients received ivabradine 7,5 mg b.i.d. and placebo for 5 days in crossover manner. HR in ECG holter monitoring, peak expiratory flow rate (PEFR), symptoms, rescue medication consumption and AEs were evaluated in both periods of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivabradine-Placebo | Active Comparator |
| |
| Placebo-Ivabradine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivabradine (Procoralan) | Drug | Ivabradine 7,5 mg b.i.d. for 5 days and Placebo b.i.d. for 5 days (Ivabradine-Placebo) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Difference in mean heart rate during ivabradine and placebo treatment | Change from baseline in heart rate during 5-day ivabradine and 5-day placebo treatment (24-hour ECG monitoring on the 3rd day) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak expiratory flow rate (PEFR) | Difference in mean daily PEFR during ivabradine and placebo treatment | Everyday measurement of morning and evening PEFR during 5-day ivabradine and 5-day placebo treatment |
| Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Lodz, Department of Pneumonology and Allergy | Lodz | 90-153 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3591616 | Background | Kannel WB, Kannel C, Paffenbarger RS Jr, Cupples LA. Heart rate and cardiovascular mortality: the Framingham Study. Am Heart J. 1987 Jun;113(6):1489-94. doi: 10.1016/0002-8703(87)90666-1. | |
| 9369286 | Background | Palatini P, Casiglia E, Pauletto P, Staessen J, Kaciroti N, Julius S. Relationship of tachycardia with high blood pressure and metabolic abnormalities: a study with mixture analysis in three populations. Hypertension. 1997 Nov;30(5):1267-73. doi: 10.1161/01.hyp.30.5.1267. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077550 | Ivabradine |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo b.i.d. for 5 days and Ivabradine 7,5 mg b.i.d. for 5 days (Placebo-Ivabradine) |
|
Difference in mean daily symptom score between ivabradine and placebo treatment
| Everyday symptom scoring during 5 day ivabradine and 5-day placebo treatment |
| Rescue medication | Difference in mean daily rescue medication use between ivabradine and placebo treatment | Everyday rescue medication usage assessments during 5-day ivabradine and 5-day placebo treatment |
| Number of participants with adverse events (AEs) | Difference in number of participants with AEs between ivabradine and placebo treatment | Number of patients with AEs evaluated throughout the study (5-day ivabradine and 5 day placebo treatment) |
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| 22409211 | Derived | Majewski S, Slomka S, Zielinska-Wyderkiewicz E, Ciebiada M, Gorski P. Heart rate-lowering efficacy and respiratory safety of ivabradine in patients with obstructive airway disease: a randomized, double-blind, placebo-controlled, crossover study. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):179-88. doi: 10.2165/11597400-000000000-00000. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |