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The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aclidinium bromide | Experimental | 3-week treatment periods |
|
| Placebo | Experimental | 3-week treatment periods |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aclidinium Bromide | Drug | 1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Endurance Time (Seconds) | Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment. | Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough Inspiratory Capacity (IC) (Litres) | Change from baseline in trough IC after 3 weeks of treatment | Week 3 |
| Change From Baseline in Intensity of Dyspnoea | Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Garcia, Ph.D. | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almirall Investigational Site #10 | Berlin | 10117 | Germany | |||
| Almirall Investigational Site #6 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25539654 | Derived | Beeh KM, Watz H, Puente-Maestu L, de Teresa L, Jarreta D, Caracta C, Garcia Gil E, Magnussen H. Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo-controlled, crossover trial. BMC Pulm Med. 2014 Dec 23;14:209. doi: 10.1186/1471-2466-14-209. |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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Eligible patients entered a 14-21 day run-in period to assess disease stability. During this period, one site visit was performed to familiarise patients with study testing procedures (body plethysmography, spirometry and a constant work rate cycle exercise test).
This study was conducted at 16 enrolling sites. A total of 14 sites randomised patients: 10 sites in Germany, 3 sites in Spain and one site in the United Kingdom. The first patient was screened in November 2011 and the last patient visit was in June 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aclidinium Bromide 400 μg - Placebo | The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Placebo | Drug | 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) |
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| Week 3 |
| Berlin |
| 10117 |
| Germany |
| Almirall Investigational Site #2 | Berlin | 14050 | Germany |
| Almirall Investigational Site #4 | Frankfurt | 60596 | Germany |
| Almirall Investigational Site #5 | Großhansdorf | 22927 | Germany |
| Almirall Investigational Site #8 | Hamburg | 20354 | Germany |
| Almirall Investigational Site #9 | Hamburg | 22335 | Germany |
| Almirall Investigational Site #3 | Hanover | 30625 | Germany |
| Almirall Investigational Site #7 | Lübeck | 23552 | Germany |
| Almirall Investigational Site #1 | Wiesbaden | 65187 | Germany |
| Almirall Investigational Site #1 | Alicante | 03114 | Spain |
| Almirall Investigational Site #4 | Barcelona | 08003 | Spain |
| Almirall Investigational Site #2 | Madrid | 28007 | Spain |
| Almirall Investigational Site #2 | London | W1G 8HU | United Kingdom |
| FG001 | Placebo - Aclidinium Bromide 400 μg | The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. |
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| NOT COMPLETED |
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| Treatment Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Safety Population | All patients randomized into the crossover study were included in the safety population |
| 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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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 Endurance Time (Seconds) | Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment. | Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population. | Posted | Least Squares Mean | Standard Error | Seconds | Week 3 |
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| Secondary | Change From Baseline in Trough Inspiratory Capacity (IC) (Litres) | Change from baseline in trough IC after 3 weeks of treatment | Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population. | Posted | Least Squares Mean | Standard Error | Litres | Week 3 |
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| Secondary | Change From Baseline in Intensity of Dyspnoea | Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment. | Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population. | Posted | Least Squares Mean | Standard Error | Units on a scale | Week 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 Bromide 400 μg Bid | Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. | 0 | 111 | 7 | 111 | ||
| EG001 | Placebo | Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks. | 2 | 108 | 4 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Troponin T increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment | Preferred term was coded as chronic obstructive pulmonary disease (COPD). However, per protocol, only COPD exacerbations (worsening of COPD symptoms for at least 2 consecutive days that required a change in COPD treatment) were reported as AEs. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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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.
| 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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| United Kingdom |
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| Participants |
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