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Aclidinium Bromide 400 μg · 2 trials · 2 indications
To assess the bronchodilatory effect by evaluating the mean changes from baseline in FEV1 at 1 hour post-dose of AB/FF 400/12 µg compared to AB 400 μg after administration of oral inhalation powder BID via DIP to participants with COPD. Baseline was defined as the average of the two FEV1 values measured just prior to the administration of the first dose of investigational product (IP) at randomization Visit. If one of the two was missing, then the available one would be used as baseline value.
To assess the bronchodilatory effect by evaluating the mean changes from baseline in FEV1 in morning pre-dose (trough) of AB/FF 400/12 µg compared to FF 12 μg after administration of oral inhalation powder BID via DPI to participants with COPD. Morning pre-dose (trough) FEV1 was defined as the average of the corresponding -30 minute and 0 minute before the morning study medication at Week 24. If one time-point was missing then the available one would be used as morning pre-dose.
To assess the non-inferior bronchodilatory effect by evaluating the mean changes from baseline in FEV1 in morning pre-dose (trough)of AB 400 µg compared to TIO 18 μg after administration of oral inhalation powder BID via DPI to participants with COPD.
| Arm | Type | Description |
|---|---|---|
| AB/FF 400/12 μg BID | EXPERIMENTAL | Participants were administered AB/FF 400/12 μg via Pressair®/Genuair® inhaler twice daily for 24 weeks of treatment. |
| AB 400 μg BID | EXPERIMENTAL | Participants were administered AB 400 μg via Pressair®/Genuair® inhaler twice daily for 24 weeks of treatment. |
| FF 12 μg BID | EXPERIMENTAL | Participants were administered FF 12 μg via Pressair®/Genuair® inhaler twice daily for 24 weeks of treatment. |
| TIO 18 μg QD | EXPERIMENTAL | Participants were administered TIO 18 μg via Handihaler® inhale once daily for 24 weeks of treatment. |
| 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 |
|---|---|---|
| Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg) | DRUG | Inhalation powder |
| Aclidinium bromide 400 μg (AB 400 μg) | DRUG | Inhalation powder |
| Formoterol fumarate 12 μg (FF 12 μg) | DRUG | Inhalation powder |
| Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg | OTHER | Inhalation powder |
| Tiotropium 18 μg (TIO 18 μg) | DRUG | Powder in capsules for oral inhalation |
| Placebo to TIO 18 μg | OTHER | Powder in capsules for oral inhalation |
| 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. |
| 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. |
Inclusion Criteria: * Adult male or non-pregnant, non-lactating female patients aged ≥40. * Patients with diagnosis of moderate to very severe stable COPD: post-bronchodilator FEV1 \< 80% of the predicted normal and post-bronchodilator FEV1/FVC \< 70% at Screening Visit. * Symptomatic patients with...
Aclidinium Bromide 400 μg is used for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is an inhaled small molecule developed by AstraZeneca PLC (ticker: AZN) and has been studied in Phase 3 clinical trials for this respiratory condition.
Aclidinium Bromide 400 μg works by targeting CHRM3, the M3 muscarinic acetylcholine receptor. It acts as an antagonist at this receptor, blocking muscarinic signaling in the airways, which is the mechanism explored for treating COPD.
Aclidinium Bromide 400 μg is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca conducted the clinical development program for this inhaled COPD therapy.
Aclidinium Bromide 400 μg is in Phase 3 development. Two clinical trials have been completed, including the Phase 3 AMPLIFY study (NCT02796677) and a Phase 2 study (NCT00868231), with no active trials currently listed.
Aclidinium Bromide 400 μg has been studied in two completed trials: the Phase 3 AMPLIFY study (NCT02796677) with 1,595 participants across multiple countries, and a Phase 2 trial (NCT00868231) with 30 participants in Germany. Both enrolled adults with COPD.