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Aclidinium Bromide 200 µg

Phase 3

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Apr 20, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment605

FDA Designations

No designations recorded

Clinical trial landscape

Aclidinium Bromide 200 µg · 2 trials · 2 indications

Phase 3 2
NCT01044459Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)Chronic Obstructive Pulmonary Disease
COMPLETED605 Analytics
NCT01001494Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) PatientsChronic Obstructive Pulmonary Disease (COPD)
COMPLETED828 Analytics
PHASE3COMPLETED
Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
From baseline to 52 weeks

Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.

Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment
Baseline and Week 24
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment
Baseline and Week 12

Secondary Endpoints

Change From Baseline in Peak FEV1
52 weeks
Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment
Baseline and Week 24
Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment
Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Aclidinium Bromide 200 µgEXPERIMENTALaclidinium bromide, inhaled, 52 weeks of treatment
Aclidinium Bromide 400 µgEXPERIMENTALaclidinium bromide, inhaled, 52 weeks of treatment
Aclidinium bromide 200 μg bidEXPERIMENTALAclidinium bromide 200 μg twice-daily via inhalation
Aclidininum bromide 400 μg bidEXPERIMENTALAclidinium bromide 400 μg twice-daily via inhalation
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
Aclidinium Bromide 200 µgDRUGaclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
Aclidinium Bromide 400 µgDRUGaclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
Aclidinium bromide 200 μg bidDRUGAclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
Aclidinium bromide 400 μg bidDRUGAclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
PlaceboDRUGPlacebo twice-daily by inhalation for 24 weeks
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites113

Inclusion Criteria: * A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2010; postbronchodilator FEV1/FVC \< 70%, and postbronchodilator FEV1 ≥ 30% and \< 80% predicted * Current or former cigarette smokers Exc...

Countries:United StatesCanadaCzechiaFranceGermanyHungaryItalyPeruPolandRussiaSouth AfricaSpainUkraine
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Frequently asked questions about Aclidinium Bromide 200 µg

What is Aclidinium Bromide 200 µg used for?

Aclidinium Bromide 200 µg is used for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is a small molecule being developed by AstraZeneca PLC (AZN) as an inhaled therapy for patients with this respiratory condition.

How does Aclidinium Bromide 200 µg work?

Aclidinium Bromide 200 µg is a small molecule designed to treat COPD by acting on the airways. Its mechanism involves bronchodilation, which helps open the airways to improve breathing in patients with chronic obstructive pulmonary disease.

Who makes Aclidinium Bromide 200 µg?

Aclidinium Bromide 200 µg is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's efficacy and safety in COPD patients.

What phase is Aclidinium Bromide 200 µg in?

Aclidinium Bromide 200 µg is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trials are designed to assess its efficacy and safety in patients with COPD.

What clinical trials is Aclidinium Bromide 200 µg in?

Aclidinium Bromide 200 µg has been studied in two completed Phase 3 trials. The first, NCT01001494, enrolled 828 patients with COPD across multiple countries. The second, NCT01044459, enrolled 605 patients with moderate to severe COPD in the United States and Canada.

Is Aclidinium Bromide 200 µg the same as aclidinium bromide?

Aclidinium Bromide 200 µg is a specific dose formulation of the drug aclidinium bromide. The 200 µg strength is being investigated for the treatment of COPD, and the clinical trials referenced evaluate this particular dose level.