Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.

NCT01120093 | Completed Phase 2 Results

• 2 other identifiers: M/34273/29LAS29
• Study Type: interventional
• Target: 79
• Locations: 2 countries
• Sites: 11

Brief Summary

The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (5)

Aclidinium bromide 100 μg bid

EXPERIMENTAL

Aclidininum bromide 100 μg twice daily by inhalation

Drug: Aclidinium bromide 100 μg bid

Aclidininum bromide 200 μg bid

EXPERIMENTAL

Aclidininum bromide 200 μg twice daily by inhalation

Drug: Aclidinium bromide 200 μg bid

Aclidininum bromide 400 μg bid

EXPERIMENTAL

Aclidininum bromide 400 μg twice daily by inhalation

Drug: Aclidininum bromide 400 μg bid

Placebo

PLACEBO COMPARATOR

Placebo twice-daily by inhalation

Drug: Placebo

Formoterol 12 μg bid

ACTIVE COMPARATOR

Formoterol 12 μg twice daily by inhalation

Drug: Formoterol 12 μg bid

Interventions

Aclidinium bromide 100 μg bid DRUG

Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days

Aclidinium bromide 100 μg bid

Aclidinium bromide 200 μg bid DRUG

Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days

Aclidininum bromide 200 μg bid

Aclidininum bromide 400 μg bid DRUG

Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days

Aclidininum bromide 400 μg bid

Placebo DRUG

Placebo via inhalation in the morning and evening for 7 days

Placebo

Formoterol 12 μg bid DRUG

Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days

Formoterol 12 μg bid

Eligibility Criteria

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

You may qualify if:

• Males and non-pregnant, non-lactating females aged ≥ 40.
• 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. Post-salbutamol FEV1/FVC \< 70% at Screening Visit (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC \<70%).
• 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 salbutamol is 30% \< FEV1 \<80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be \< 80% and ≥ 30%).
• Female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception.
• Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent.

You may not qualify if:

• History or current diagnosis of asthma.
• Clinically significant respiratory conditions other than COPD 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.
• Clinically significant cardiovascular conditions
• Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
• Presence of narrow-angle glaucoma.
• QTcB) 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 (11)

Almirall Investigational Sites#1

Ghent, B-9000, Belgium

Location

Almirall Investigational Sites#3

Berlin, 10117, Germany

Location

Almirall Investigational Sites#4

Berlin, 13125, Germany

Location

Almirall Investigational Sites#9

Berlin, 14050, Germany

Location

Almirall Investigational Sites#8

Frankfurt, 60596, Germany

Location

Almirall Investigational Sites#1

Groβhansdorf, 22927, Germany

Location

Almirall Investigational Sites#5

Hamburg, 20249, Germany

Location

Almirall Investigational Sites#7

Hanover, 30159, Germany

Location

Almirall Investigational Sites#2

Hanover, 30625, Germany

Location

Almirall Investigational Sites#6

Schwerin, 19055, Germany

Location

Almirall Investigational Sites#10

Wiesbaden, 65187, Germany

Location

Related Publications (1)

• Singh D, Magnussen H, Kirsten A, Mindt S, Caracta C, Seoane B, Jarreta D, Garcia Gil E. A randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients. Pulm Pharmacol Ther. 2012 Jun;25(3):248-53. doi: 10.1016/j.pupt.2012.03.008. Epub 2012 Apr 4.

  PMID: 22497752 DERIVED

Related Links

• Almirall Corporate Website
• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

aclidinium bromide; BID protein, human; Formoterol Fumarate

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)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

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: May 7, 2010
• First Posted: May 10, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 9, 2017
• Results First Posted: September 12, 2012

Record last verified: 2016-11

Locations

DE (10); BE (1)