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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004715-37 | EudraCT Number | ||
| M-34273-46 | Other Identifier | Clinical Trial Protocol Code |
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| Name | Class |
|---|---|
| Menarini Group | INDUSTRY |
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The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID compared with placebo on COPD symptoms in a symptomatic patients population with moderate COPD and chronic bronchitis, and particularly assess the effects in cough by using specific tools to assess the occurrence and impact of this relevant COPD symptom.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aclidinium Bromide 400 μg | Experimental | Aclidinium Bromide 400 μg twice daily by inhalation |
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| Placebo | Placebo Comparator | placebo twice daily by inhalation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aclidinium Bromide | Drug | Inhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period | The EXACT-Respiratory Symptoms (E-RS) questionnaire was completed every evening The E-RS scale is an instrument comprising a subset of EXACT items to test the effect of treatment on the severity of respiratory symptoms in stable COPD Eleven of the 14-items of the EXACT questionnaire provides information about COPD symptoms: The E-RS Total Score is an aggregate of three domains: chest symptoms (derived sum of 3 items), cough and sputum (derived sum of 3 items) and RS-breathlessness (derived sum of 4 items); Individual scores were rated from 0 to 4 The E-RS Total score is based on a logit scoring system with conversion to a 0 (lowest score) to 100 scale (highest score) with higher scores indicating more severe symptoms | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period | The scale range of the 'cough and sputum' domain of the E-RS was 0-11, with higher scores indicating more severe symptoms | Baseline to Week 8 |
| Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | Germany | ||||
| Research Site |
300 patients were screened; 269 were assessed as eligible and were randomized into the study
Thirty-one patients failed screening, with the main reason for screening failure being non-fulfilment of the inclusion or exclusion criteria (24 patients)
Patients were randomized in 30 study sites in 5 countries Germany (10 sites), Hungary (6), Italy (2), Spain (9) and the United Kingdom (3)
First patient was enrolled in March 2015 and last patient last visit was in November 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | Aclidinium 400 μg | Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler |
| FG001 | Placebo | Placebo BID administered by Genuair® multidose dry powder inhaler |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Inhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler |
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The LCQ is a self-administered questionnaire that assesses cough related quality of life The LCQ comprises 19 items and 3 domains (physical, psychological and social) The total score ranges from 3 to 21 and each domain scores range from 1 to 7; a higher score indicates a better quality of life |
| Week 8 |
| Dortmund |
| Germany |
| Research Site | Frankfurt | Germany |
| Research Site | Frankfurt am Main | Germany |
| Research Site | Hanover | Germany |
| Research Site | Lübeck | Germany |
| Research Site | Balassagyarmat | Hungary |
| Research Site | Debrecen | Hungary |
| Research Site | Komárom | Hungary |
| Research Site | Nyíregyháza | Hungary |
| Research Site | Pécs | Hungary |
| Research Site | Százhalombatta | Hungary |
| Research Site | Naples | Italy |
| Research Site | Pisa | Italy |
| Research Site | Alicante | Spain |
| Research Site | Barcelona | Spain |
| Research Site | Hospitalet de Llobregat(Barcel | Spain |
| Research Site | Laredo | Spain |
| Research Site | Madrid | Spain |
| Research Site | Santiago(A Coruña) | Spain |
| Research Site | Seville | Spain |
| Research Site | Manchester | United Kingdom |
| Research Site | Northwood | United Kingdom |
| Research Site | Sidcup | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aclidinium 400 μg | Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler |
| BG001 | Placebo | Placebo BID administered by Genuair® multidose dry powder inhaler |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period | The EXACT-Respiratory Symptoms (E-RS) questionnaire was completed every evening The E-RS scale is an instrument comprising a subset of EXACT items to test the effect of treatment on the severity of respiratory symptoms in stable COPD Eleven of the 14-items of the EXACT questionnaire provides information about COPD symptoms: The E-RS Total Score is an aggregate of three domains: chest symptoms (derived sum of 3 items), cough and sputum (derived sum of 3 items) and RS-breathlessness (derived sum of 4 items); Individual scores were rated from 0 to 4 The E-RS Total score is based on a logit scoring system with conversion to a 0 (lowest score) to 100 scale (highest score) with higher scores indicating more severe symptoms | Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product E-RS data were available for 131/135 patients receiving aclidinium and 133/134 receiving placebo | Posted | Least Squares Mean | Standard Error | Score | Baseline to Week 8 |
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| Secondary | Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period | The scale range of the 'cough and sputum' domain of the E-RS was 0-11, with higher scores indicating more severe symptoms | Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product E-RS data were available for 131/135 patients receiving aclidinium and 133/134 receiving placebo | Posted | Least Squares Mean | Standard Error | Score | Baseline to Week 8 |
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| Secondary | Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 8 | The LCQ is a self-administered questionnaire that assesses cough related quality of life The LCQ comprises 19 items and 3 domains (physical, psychological and social) The total score ranges from 3 to 21 and each domain scores range from 1 to 7; a higher score indicates a better quality of life | Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product LCQ data were available for 126/135 patients receiving aclidinium and 128/134 receiving placebo | Posted | Least Squares Mean | Standard Error | Score | Week 8 |
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Day 70±3
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aclidinium 400 μg | Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler | 2 | 135 | 11 | 135 | ||
| EG001 | Placebo | Placebo BID administered by Genuair® multidose dry powder inhaler | 2 | 134 | 20 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Cartilage injury | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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Publication and/or presentation whether complete or partial, of any part of the data or results of this trial will not be allowed until global publication and study results disclosure by the sponsor as per EMA / FDA regulatory compliance obligations, and only after mutual agreement between the investigator and the sponsor
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical | Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C542859 | aclidinium bromide |
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| Male |
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