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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01120093
First received: May 7, 2010
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Aclidinium bromide 100 μg bid
Drug: Aclidinium bromide 200 μg bid
Drug: Aclidininum bromide 400 μg bid
Drug: Placebo
Drug: Formoterol 12 μg bid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator All Administered Twice Daily by Inhalation in Patients With Stable Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD).

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: May 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aclidinium bromide 100 μg bid
Aclidininum bromide 100 μg twice daily by inhalation
Drug: Aclidinium bromide 100 μg bid
Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
Experimental: Aclidininum bromide 200 μg bid
Aclidininum bromide 200 μg twice daily by inhalation
Drug: Aclidinium bromide 200 μg bid
Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
Experimental: Aclidininum bromide 400 μg bid
Aclidininum bromide 400 μg twice daily by inhalation
Drug: Aclidininum bromide 400 μg bid
Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
Placebo Comparator: Placebo
Placebo twice-daily by inhalation
Drug: Placebo
Placebo via inhalation in the morning and evening for 7 days
Active Comparator: Formoterol 12 μg bid
Formoterol 12 μg twice daily by inhalation
Drug: Formoterol 12 μg bid
Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and non-pregnant, non-lactating females aged ≥ 40.
  2. 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%).
  3. Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.
  4. 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%).
  5. 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.
  6. Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent.

Exclusion Criteria:

  1. History or current diagnosis of asthma.
  2. Clinically significant respiratory conditions other than COPD at the time of Inform Consent signature
  3. Hospitalisation due to COPD exacerbation within the previous 3 months.
  4. Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.
  5. Clinically significant cardiovascular conditions
  6. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
  7. Presence of narrow-angle glaucoma.
  8. QTcB) above 470 milliseconds in the ECG performed at Screening Visit,
  9. Patient who does not maintain regular day/night, waking/sleeping cycles
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120093

Locations
Belgium
Almirall Investigational Sites#1
Gent, Belgium, B-9000
Germany
Almirall Investigational Sites#3
Berlín, Germany, 10117
Almirall Investigational Sites#9
Berlín, Germany, 14050
Almirall Investigational Sites#4
Berlín, Germany, 13125
Almirall Investigational Sites#8
Frankfurt, Germany, 60596
Almirall Investigational Sites#1
Groβhansdorf, Germany, 22927
Almirall Investigational Sites#5
Hamburg, Germany, 20249
Almirall Investigational Sites#7
Hannover, Germany, 30159
Almirall Investigational Sites#2
Hannover, Germany, 30625
Almirall Investigational Sites#6
Schwerin, Germany, 19055
Almirall Investigational Sites#10
Wiesbaden, Germany, 65187
Sponsors and Collaborators
Almirall, S.A.
Forest Laboratories
Investigators
Study Director: Estrella Garcia, PhD Almirall Global Clinical Operations & SR
  More Information

Additional Information:
No publications provided

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01120093     History of Changes
Other Study ID Numbers: M/34273/29, LAS29
Study First Received: May 7, 2010
Results First Received: August 14, 2012
Last Updated: August 14, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Almirall, S.A.:
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Phenylpropanolamine
Guaifenesin
Formoterol
Chlorpheniramine, phenylpropanolamine drug combination
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014