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| ID | Type | Description | Link |
|---|---|---|---|
| M-40464-33 | Other Identifier | Clinical Trial Protocol Code | |
| 2014-005318-50 | EudraCT Number |
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| Name | Class |
|---|---|
| Menarini Group | INDUSTRY |
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The present study is planned to evaluate the effect of the aclidinium bromide/formoterol fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in patients with moderate to severe COPD. Additionally, the effect of the behavioural intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both on the exercise endurance and the physical activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aclidinium Bromide/Formoterol Fumarate FDC 400/12μg | Experimental | 8 weeks, double blind treatment period |
|
| Placebo to Aclidinium/Formoterol | Placebo Comparator | 8 weeks, double blind treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aclidinium/Formoterol | Drug | Aclidinium bromide/Formoterol fumarate FDC 400/12μg dry powder for oral inhalation twice daily via Genuair inhaler |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment | Baseline values in FRC were defined as the corresponding values just before randomization on Day 1 of treatment (Week 0). Trough values were obtained prior to study drug administration. | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Endurance Time (ET) During Constant Work Rate Cycle Ergometry at Week 8 | The ET was the time from the increase in work rate to 75% Wmax to the point of symptom limitation. Baseline measurements were taken prior to the IP dose on Day 1. Measurements at Week 8 were taken at 3 hours post-dose. Participants underwent a behavioural intervention (consisting of a telecoaching programme to enhance physical activity) between Week 4 and Week 8. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hamilton | Ontario | L8N 3Z5 | Canada | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35342289 | Derived | Koopman M, Franssen FME, Gaffron S, Watz H, Troosters T, Garcia-Aymerich J, Paggiaro P, Molins E, Moya M, van Burk L, Maier D, Garcia Gil E, Wouters EFM, Vanfleteren LEGW, Spruit MA. Differential Outcomes Following 4 Weeks of Aclidinium/Formoterol in Patients with COPD: A Reanalysis of the ACTIVATE Study. Int J Chron Obstruct Pulmon Dis. 2022 Mar 8;17:517-533. doi: 10.2147/COPD.S308600. eCollection 2022. |
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335 patients were screened; 267 were assessed as eligible and were randomized into the study. 68 patients failed screening. The main reason for screening failure was non-fulfilment of inclusion or exclusion criteria (16.7%).
This study was conducted at 26 study centers, 15 in Germany, 4 in Hungary, 3 in Spain and 4 in Canada. The first patient was enrolled in April 2015 and the last patient visit was in July 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | AB/FF 400/12 μg | Aclidinium Bromide/Formoterol Fumarate 400/12 μg |
| FG001 | Placebo | Placebo to Aclidinium/Formoterol |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Dose-matched placebo dry powder for oral inhalation twice daily via Genuair inhaler |
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| Baseline to Week 8 |
| Percentage of Inactive Patients (Mean of <6000 Steps Per Day) at Week 8 | Physical activity was assessed by means of measurement of activity parameters (e.g. number of steps) through a Dynaport MoveMonitor and completion of the Daily ProActive Physical Activity in chronic obstructive pulmonary disease (COPD) questionnaire. Compliant criterion based on at least 8 hours per day, and at least 3 days per week. Participants underwent a behavioural intervention (consisting of a telecoaching programme to enhance physical activity) between Week 4 and Week 8. Baseline was defined as mean of steps/day assessed during the week before the randomisation visit. | Week 8 |
| Kingston |
| Ontario |
| K7L 2V7 |
| Canada |
| Research Site | Sainte-Foy | Quebec | G1V 4G5 | Canada |
| Research Site | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Research Site | Berlin | 10117 | Germany |
| Research Site | Berlin | 10717 | Germany |
| Research Site | Berlin | 10787 | Germany |
| Research Site | Berlin | 10969 | Germany |
| Research Site | Berlin | 13086 | Germany |
| Research Site | Dortmund | 44263 | Germany |
| Research Site | Frankfurt | 60596 | Germany |
| Research Site | Großhansdorf | 22927 | Germany |
| Research Site | Hamburg | 20253 | Germany |
| Research Site | Hamburg | 20354 | Germany |
| Research Site | Hanover | 30173 | Germany |
| Research Site | Jena | 7740 | Germany |
| Research Site | Lübeck | 23552 | Germany |
| Research Site | München | 80331 | Germany |
| Research Site | Wiesbaden | 65187 | Germany |
| Research Site | Budapest | 1125 | Hungary |
| Research Site | Deszk | 6772 | Hungary |
| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Törökbálint | 2045 | Hungary |
| Research Site | Alicante | 03004 | Spain |
| Research Site | Cáceres | 10003 | Spain |
| Research Site | Madrid | 28046 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Population defined as all randomized patients who took at least one dose of investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | AB/FF 400/12 μg | Aclidinium Bromide/Formoterol Fumarate 400/12 μg |
| BG001 | Placebo | Placebo to Aclidinium/Formoterol |
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment | Baseline values in FRC were defined as the corresponding values just before randomization on Day 1 of treatment (Week 0). Trough values were obtained prior to study drug administration. | The intent-to-treat (ITT) population - equal to the Safety population and defined as all randomised patients who took at least one dose of investigational product (IP) - who had available trough FRC values at baseline and Week 4. | Posted | Least Squares Mean | Standard Error | Liters | Baseline and Week 4 |
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| Secondary | Change From Baseline in Endurance Time (ET) During Constant Work Rate Cycle Ergometry at Week 8 | The ET was the time from the increase in work rate to 75% Wmax to the point of symptom limitation. Baseline measurements were taken prior to the IP dose on Day 1. Measurements at Week 8 were taken at 3 hours post-dose. Participants underwent a behavioural intervention (consisting of a telecoaching programme to enhance physical activity) between Week 4 and Week 8. | Intention-to-treat population - which was equal to the safety population, defined as all participants who took at least one dose of investigational product - who had available ET values at baseline and Week 8. | Posted | Least Squares Mean | Standard Error | Seconds | Baseline to Week 8 |
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| Secondary | Percentage of Inactive Patients (Mean of <6000 Steps Per Day) at Week 8 | Physical activity was assessed by means of measurement of activity parameters (e.g. number of steps) through a Dynaport MoveMonitor and completion of the Daily ProActive Physical Activity in chronic obstructive pulmonary disease (COPD) questionnaire. Compliant criterion based on at least 8 hours per day, and at least 3 days per week. Participants underwent a behavioural intervention (consisting of a telecoaching programme to enhance physical activity) between Week 4 and Week 8. Baseline was defined as mean of steps/day assessed during the week before the randomisation visit. | The intent-to-treat (ITT) population - equal to the Safety population and defined as all randomised patients who took at least one dose of IP - who had available activity data (compliant criterion). | Posted | Number | Percent of inactive participants | Week 8 |
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From Screening, Week -2 (Days -17 to -11) to Follow-up, Week 10 (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 | AB/FF 400/12 μg | Aclidinium Bromide/Formoterol Fumarate 400/12 μg | 2 | 134 | 14 | 134 | ||
| EG001 | Placebo | Placebo to Aclidinium/Formoterol | 3 | 133 | 24 | 133 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA version 18.0 | Systematic Assessment |
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| Lens dislocation | Eye disorders | MedDRA version 18.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Pubis fracture | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
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Publication of the results by the Principal Investigator (PI) will be subject to mutual agreement between the PI and the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | AstraZeneca | ClinicalTrialTransparency@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 |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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| Male |
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