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Anticholinergic

Aclidinium for Asthma

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline week 0 (visit 4) to week 6 (visit 6)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

Summary

This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria were randomized to one of two treatment groups: aclidinium bromide or placebo.

Eligible Conditions
  • Asthma
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (visit 4) at week 6 (visit 6)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (visit 4) at week 6 (visit 6) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Exercise Endurance Time (ET)
Secondary study objectives
Functional Residual Capacity (FRC)
Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio
Trough Forced Expiratory Volume in 1 Second (FEV1)
+1 more

Side effects data

From 2017 Phase 4 trial • 3635 Patients • NCT01966107
5%
Upper Respiratory Tract Infection
5%
Urinary Tract Infection
4%
Hypertension
4%
Pneumonia
4%
Viral Upper Respiratory Tract Infection
4%
Sinusitis
4%
Cough
4%
Back Pain
4%
Bronchitis
4%
Nausea
3%
Dyspnoea
3%
Headache
3%
Arthralgia
3%
Oedema Peripheral
3%
Diarrhoea
3%
Constipation
2%
Pain In Extremity
2%
Atrial Fibrillation
2%
Anxiety
2%
Dizziness
2%
Musculoskeletal Pain
2%
Anaemia
2%
Muscle Spasms
2%
Gastrooesophageal Reflux Disease
1%
Coronary Artery Disease
1%
Cellulitis
1%
Sepsis
1%
Non-Cardiac Chest Pain
1%
Cardiac Failure Congestive
1%
Respiratory Failure
1%
Cerebrovascular Accident
1%
Acute Respiratory Failure
1%
Acute Myocardial Infarction
1%
Angina Pectoris
1%
Myocardial Infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aclidinium Bromide
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AclidiniumExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aclidinium
FDA approved

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,506 Total Patients Enrolled
348 Trials studying Asthma
661,469 Patients Enrolled for Asthma
Esther Garcia, MDStudy DirectorAstraZeneca
18 Previous Clinical Trials
8,825 Total Patients Enrolled
1 Trials studying Asthma
174 Patients Enrolled for Asthma
~10 spots leftby Nov 2025
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