Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate

NCT01078623 | Completed Phase 2 Results

• 1 other identifier: M/40464/26
• Study Type: interventional
• Target: 176
• Locations: 2 countries
• Sites: 10

Brief Summary

The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD. Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Bronchitis; Chronic; Emphysema

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14

  FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose

  0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14

Secondary Outcomes (2)

• Change From Baseline in Morning Pre-dose FEV1 at Day 14

  Day 14

• Change From Baseline in Morning Peak FEV1 at Day 14

  0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14

Study Arms (5)

Formoterol 12 μg

ACTIVE COMPARATOR

Formoterol fumarate 12 μg twice daily

Drug: Formoterol 12 μg

Placebo

PLACEBO COMPARATOR

Placebo twice daily

Drug: Placebo

Aclidinium 200 μg / formoterol 12 μg

EXPERIMENTAL

Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily

Drug: Aclidinium 200 μg / formoterol 12 μg

Aclidinium 200 μg / formoterol 6 μg

EXPERIMENTAL

Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily

Drug: Aclidinium 200 μg / Formoterol 6 μg

Aclidinium 200 μg

EXPERIMENTAL

Aclidinium bromide 200 μg twice daily

Drug: Aclidinium 200 μg

Interventions

Aclidinium 200 μg / formoterol 12 μg DRUG

Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily

Aclidinium 200 μg / formoterol 12 μg

Placebo DRUG

Placebo control twice daily

Placebo

Formoterol 12 μg DRUG

Formoterol fumarate 12 μg twice daily

Formoterol 12 μg

Aclidinium 200 μg DRUG

Aclidinium bromide 200 μg twice daily

Aclidinium 200 μg

Aclidinium 200 μg / Formoterol 6 μg DRUG

Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily

Aclidinium 200 μg / formoterol 6 μg

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive.
• Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification
• Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.
• Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is 30% FEV1 \<80% of the predicted normal value (i.e., 100 x Post-salbutamol \< FEV1/ Predicted FEV1 must be \< 80% and ≥ 30%).
• Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is \< 70% (i.e., 100 x Post-salbutamol FEV1 /FVC \< 70%).
• Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.
• Patient whose COPD symptoms and FEV1 values at the time of randomisation are stable compared to the Screening Visit, according to the investigator's medical judgment

You may not qualify if:

• History or current diagnosis of asthma or exercise-induced bronchospasm.
• Clinically significant respiratory conditions at the time of Inform Consent signature
• Hospitalisation due to COPD exacerbation within the previous 3 months.
• Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.
• Patient who has a resting systolic blood pressure ≥ 200 mmHg, a resting diastolic blood pressure ≥ 120 mmHg or a resting heart rate ≥ 105 bpm at screening visit.
• Clinically significant cardiovascular conditions
• Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
• Presence of narrow-angle glaucoma.
• QTc \[calculated according to Bazett's formulae (QTc=QT/RR1/2) above 470 milliseconds in the ECG performed at Screening Visit,
• Patient who does not maintain regular day/night, waking/sleeping cycles

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (10)

Research Site

Bucuresti, Czechia

Location

Research Site

Constanta, Czechia

Location

Research Site

Iasi, Czechia

Location

Research Site

Tg Mures, Czechia

Location

Research Site

Bucharest, Romania

Location

Research Site

Cluj-Napoca, Romania

Location

Research Site

Deva, Romania

Location

Research Site

Iași, Romania

Location

Research Site

Oradea, Romania

Location

Research Site

Timișoara, Romania

Location

Related Links

• Almirall Corporate Website
• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis; Bronchiolitis Obliterans Syndrome; Emphysema

Interventions

aclidinium bromide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Bronchial Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Study Director
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

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 1, 2010
• First Posted: March 2, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 23, 2017
• Results First Posted: November 15, 2016

Record last verified: 2016-12

Locations

RO (6); CZ (4)