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Aclidinium bromide 100 μg

Phase 2

Chronic Obstructive Pulmonary Disease (COPD) | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jan 9, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment79

FDA Designations

No designations recorded

Clinical trial landscape

Aclidinium bromide 100 μg · 1 trial · 1 indication

Phase 2 1
NCT01120093Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED79 Analytics
PHASE2COMPLETED
Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment
Day 7

Secondary Endpoints

Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment
Day 7
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment
Day 7
Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment
Day 7
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Aclidinium bromide 100 μg bidEXPERIMENTALAclidininum bromide 100 μg twice daily by inhalation
Aclidininum bromide 200 μg bidEXPERIMENTALAclidininum bromide 200 μg twice daily by inhalation
Aclidininum bromide 400 μg bidEXPERIMENTALAclidininum bromide 400 μg twice daily by inhalation
PlaceboPLACEBO_COMPARATORPlacebo twice-daily by inhalation
Formoterol 12 μg bidACTIVE_COMPARATORFormoterol 12 μg twice daily by inhalation

Interventions

NameTypeDescription
Aclidinium bromide 100 μg bidDRUGAclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
Aclidinium bromide 200 μg bidDRUGAclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
Aclidininum bromide 400 μg bidDRUGAclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
PlaceboDRUGPlacebo via inhalation in the morning and evening for 7 days
Formoterol 12 μg bidDRUGFormoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. Males and non-pregnant, non-lactating females aged ≥ 40. 2. Patients with a clinical diagnosis of stable moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines: (http://www.goldcopd.com) and stable airway obstruction...

Countries:BelgiumGermany
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Frequently asked questions about Aclidinium bromide 100 μg

What is Aclidinium bromide 100 μg used for?

Aclidinium bromide 100 μg is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is a long-acting muscarinic antagonist that is administered via inhalation to help manage symptoms of COPD.

Who makes Aclidinium bromide 100 μg?

Aclidinium bromide 100 μg is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN.

What phase is Aclidinium bromide 100 μg in?

Aclidinium bromide 100 μg is currently in Phase 2 of clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for its efficacy and safety in patients with COPD.

What clinical trials is Aclidinium bromide 100 μg in?

Aclidinium bromide 100 μg has been studied in one completed Phase 2 clinical trial, identified by the National Clinical Trial number NCT01120093. This trial evaluated the efficacy and safety of three doses of aclidinium bromide compared to placebo and an active comparator in patients with COPD.

Is Aclidinium bromide 100 μg the same as aclidinium bromide?

Yes, Aclidinium bromide 100 μg is a specific dose of the drug aclidinium bromide. The 100 μg formulation is being investigated as a potential treatment for COPD, and it is the dose that was evaluated in the Phase 2 clinical trial.