Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT00868231 | Completed Phase 2 Results

• 1 other identifier: M/34273/23
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Antimuscarinic

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment.

  Day 15

Secondary Outcomes (11)

• Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment

  Day 15

• Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment

  Day 15

• Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC0-12) in Liters at Day 1 on Treatment

  Day 1

• Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment

  Day 1

• Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment

  Day 1

Study Arms (3)

Aclidinium 400 μg bid

EXPERIMENTAL

Aclidinium bromide 400 μg twice-daily by inhalation

Drug: Aclidinium bromide 400 μg bid

Tiotropium 18 μg once-daily

ACTIVE COMPARATOR

Tiotropium 18 μg once-daily by inhalation

Drug: Tiotropium 18 μg once-daily

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

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.

Aclidinium 400 μg bid

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.

Tiotropium 18 μg once-daily

Placebo DRUG

Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female patients aged 40 with stable moderate to severe COPD (GOLD guidelines).
• Post-salbutamol (FEV1) \< 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%.
• Current or ex smokers of 10 pack-years.

You may not qualify if:

• Patients with no history or current diagnosis of asthma.
• No evidence of an exacerbation within 6 weeks prior to the screening visit.
• No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
• No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Almirall Investigational Site #1

Berlin, D-14050, Germany

Location

Almirall Investigational Site #2

Großhansdorf, D-22927, Germany

Location

Related Publications (1)

• Fuhr R, Magnussen H, Sarem K, Llovera AR, Kirsten AM, Falques M, Caracta CF, Garcia Gil E. Efficacy of aclidinium bromide 400 mug twice daily compared with placebo and tiotropium in patients with moderate to severe COPD. Chest. 2012 Mar;141(3):745-752. doi: 10.1378/chest.11-0406. Epub 2011 Sep 8.

  PMID: 21903737 DERIVED

Related Links

• Almirall Corporate Website

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

aclidinium bromide; BID protein, human; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: AstraZeneca Clinical
• Organization: Study Information Center

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Esther Garcia, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 4, 2017
• Results First Posted: September 12, 2012

Record last verified: 2016-09

Locations

DE (2)