Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01908140 | Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD) | PHASE3 | COMPLETED | 933 | — | — | Sep 1, 2013 | Aug 1, 2014 | Mar 7, 2016 | 126 | Austria, Bulgaria +12 |
| NCT01462929 | Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) | PHASE3 | COMPLETED | 414 | — | — | Nov 1, 2011 | May 1, 2012 | Jan 4, 2017 | 41 | Czechia, Germany +2 |
| NCT01471171 | Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) | PHASE3 | COMPLETED | 112 | — | — | Nov 1, 2011 | Jun 1, 2012 | Jan 4, 2017 | 14 | Germany, Spain +1 |
| NCT01462942 | Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination | PHASE3 | COMPLETED | 2,443 | — | — | Oct 1, 2011 | Jan 1, 2013 | Feb 15, 2017 | 197 | Austria, Belgium +20 |
| NCT00435760 | Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients | PHASE3 | COMPLETED | 115 | — | — | Feb 1, 2007 | Aug 1, 2007 | Nov 17, 2016 | 1 | United Kingdom |
| NCT00358436 | Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD) | PHASE3 | COMPLETED | 804 | — | — | Aug 1, 2006 | Jun 1, 2008 | Jan 4, 2017 | 120 | United States, Argentina +5 |
| NCT00363896 | A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) | PHASE3 | COMPLETED | 843 | — | — | Jul 1, 2006 | May 1, 2008 | Jan 6, 2017 | 132 | Andorra, Austria +14 |
| NCT00626522 | Aclidinium/Formoterol Fixed Combination Dose Finding Study | PHASE2 | COMPLETED | 808 | — | — | Feb 1, 2008 | Nov 1, 2008 | Nov 16, 2016 | 9 | Australia, Czechia +2 |
Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration
Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.
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.
Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks
Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks
| Arm | Type | Description |
|---|---|---|
| Aclidinium Bromide / Formoterol Fumarate | EXPERIMENTAL | Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks |
| Salmeterol / Fluticasone propionate | ACTIVE_COMPARATOR | Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks |
| Aclidinium bromide | EXPERIMENTAL | Aclidinium bromide 400 µg administered twice per day during 6 weeks of treatment |
| Tiotropium | ACTIVE_COMPARATOR | Tiotropium bromide 18 µg administered once per day during 6 weeks of treatment |
| Placebo | PLACEBO_COMPARATOR | Placebo comparator administered during 6 weeks of treatment |
| Aclidinium/Formoterol 400/6 μg | EXPERIMENTAL | 24 week, double blind treatment period |
| Aclidinium/Formoterol 400/12 μg | EXPERIMENTAL | 24 week, double blind treatment period |
| Aclidinium monotherapy 400 μg | EXPERIMENTAL | 24 week, double blind treatment period |
| Formoterol monotherapy 12 μg | ACTIVE_COMPARATOR | 24 week, double blind treatment period |
| Aclidinium 200 μg once-daily | EXPERIMENTAL | Aclidinium bromide 200 μg once-daily by inhalation |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | PLACEBO_COMPARATOR | - |
| 5 | PLACEBO_COMPARATOR | - |
| 6 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Aclidinium Bromide / Formoterol Fumarate | DRUG | - |
| Salmeterol / Fluticasone | DRUG | - |
| Aclidinium bromide | DRUG | Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) |
| Tiotropium | DRUG | Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) |
| Placebo | DRUG | Dosage form: Dry powder Route of administration: 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) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h). |
| Aclidinium Bromide/Formoterol Fumarate | DRUG | Inhaled Aclidinium/formoterol Fixed Dose Combination (FDC) low dose (400/6 μg), twice per day |
| Formoterol Fumarate | DRUG | Inhaled Formoterol 12 μg, twice per day |
| Placebo Tiotropium | DRUG | 1 puff once daily, 1 day treatment |
| Placebo LAS34273 | DRUG | 1 puff, 1 dat treatment |
| Aclidinium bromide and formoterol | DRUG | once daily |
| Aclidinium bromide and formoterol placebo | DRUG | once daily |
Inclusion Criteria: * Adult male or non-pregnant, non-lactating female aged ≥40. * Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years * Patients with a clinical diagnosis of COPD according to GOLD guidelines 2013, with a post-bronchodilator FEV1 \<80%, and FEV1/FVC \< ...