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The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aclidinium 400 μg bid | Experimental | Aclidinium bromide 400 μg twice-daily by inhalation |
|
| Tiotropium 18 μg once-daily | Active Comparator | Tiotropium 18 μg once-daily by inhalation |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aclidinium bromide 400 μg bid | Drug | Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment. | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment | Day 15 | |
| Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Garcia, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almirall Investigational Site #1 | Berlin | D-14050 | Germany | |||
| Almirall Investigational Site #2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21903737 | Derived | Fuhr R, Magnussen H, Sarem K, Llovera AR, Kirsten AM, Falques M, Caracta CF, Garcia Gil E. Efficacy of aclidinium bromide 400 mug twice daily compared with placebo and tiotropium in patients with moderate to severe COPD. Chest. 2012 Mar;141(3):745-752. doi: 10.1378/chest.11-0406. Epub 2011 Sep 8. |
| Label | URL |
|---|---|
| Almirall Corporate Website | View source |
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Eligible patients had at least a 5-day run-in period (and a maximum of 9 days) to assess patient's clinical stability.
This study was conducted at 2 sites in Germany. The first patient was screened in Mar 2009 and the last patient visit was in Jul 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aclidinium 400 μg BID - Placebo - Tiotropium 18 μg | The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days. In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. |
| FG001 | Aclidinium 400 μg BID - Tiotropium 18 μg - Placebo | The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days. In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. |
| FG002 | Tiotropium 18 μg - Aclidinium 400 μg BID - Placebo | The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days. In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. |
| FG003 | Tiotropium 18 μg - Placebo - Aclidinium 400 μg BID | The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days. In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the evening and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium from the Eklira Genuair® inhaler in the evening for 15 consecutive days. |
| FG004 | Placebo - Aclidinium 400 μg BID - Tiotropium 18 μg | The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days. In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. |
| FG005 | Placebo - Tiotropium 18 μg - Aclidinium 400 μg BID | The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days. In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days. In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler at in the evening for 15 consecutive days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
| ||||||||||||||||||
| Treatment Period 2 |
| |||||||||||||||||||
| Treatment Period 3 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | All patients randomized into the crossover study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment. | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 15 |
|
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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 | Aclidininum Bromide 400 μg Bid | Aclidinium bromide 400 μg twice-daily via inhalation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical | Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
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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 |
|---|---|
| C542859 | aclidinium bromide |
| C494814 | BID protein, human |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Tiotropium 18 μg once-daily | Drug | Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days. |
|
| Placebo | Drug | Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days. |
|
| Day 15 |
| Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC0-12) in Liters at Day 1 on Treatment | Day 1 |
| Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment | Day 1 |
| Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment | Day 1 |
| Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment | Day 15 |
| Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 15 on Treatment | Day 15 |
| Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment | Day 15 |
| Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 1 on Treatment | Day 1 |
| Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment | Day 1 |
| Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment | Day 1 |
| Großhansdorf |
| D-22927 |
| Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Placebo via inhalation |
|
|
| Secondary | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 15 |
|
|
|
| Secondary | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 15 |
|
|
|
| Secondary | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC0-12) in Liters at Day 1 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 1 |
|
|
|
| Secondary | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 1 |
|
|
|
| Secondary | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 1 |
|
|
|
| Secondary | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 15 |
|
|
|
| Secondary | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 15 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 15 |
|
|
|
| Secondary | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 15 |
|
|
|
| Secondary | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 1 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 1 |
|
|
|
| Secondary | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 1 |
|
|
|
| Secondary | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment | Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1 | Posted | Least Squares Mean | Standard Error | Liters | Day 1 |
|
|
|
| 0 |
| 29 |
| 2 |
| 29 |
| EG001 | Tiotropium 18 μg Once-daily | Tiotropium 18 μg once-daily by inhalation | 0 | 28 | 0 | 28 |
| EG002 | Placebo | Placebo via inhalation | 1 | 30 | 3 | 30 |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
All the information related to this clinical trial is considered strictly confidential and is the property of Almirall. This information will not be given to a third party without the written consent of Almirall. Publication and/or presentation, whether complete or partial, of any part of the data or results of this trial will be subject to revision and written agreement between the investigator and Almirall.
| 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 |