Long-term Efficacy and Safety of Aclidinium/Formoterol Fixed-Dose Combination

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01462942
First received: October 26, 2011
Last updated: February 8, 2013
Last verified: October 2011
  Purpose

The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Aclidinium Bromide/Formoterol Fumarate
Drug: Aclidinium Bromide
Drug: Placebo
Drug: Formoterol Fumarate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in morning pre-dose (through) Forced Expiratory Volume in one second (FEV1) [ Time Frame: Change from Baseline (Week 0) to 24 Weeks ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in one second (FEV1)will be measured

  • Change from baseline in 1-hour post-morning dose Forced Expiratory Volume in one second (FEV1) [ Time Frame: Change from Baseline (Week 0) to 24 Weeks ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in one second (FEV1)will be measured


Secondary Outcome Measures:
  • Improvement of Transition Dyspnoea Index (TDI) focal score [ Time Frame: Change from Baseline (Week 0) to 24 Weeks ] [ Designated as safety issue: No ]
    Transition Dyspnoea Index will be recorded

  • Change from baseline in St. George´s Respiratory Questionnaire(SGRQ) total score [ Time Frame: Change from Baseline (Week 0) to 24 Weeks ] [ Designated as safety issue: No ]
    St. George´s Respiratory Questionnaire will be used to record the total score


Enrollment: 1731
Study Start Date: October 2011
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aclidinium/formoterol Fixed Dose Combination (FDC) low dose
24 week, double blind treatment period
Drug: Aclidinium Bromide/Formoterol Fumarate
Inhaled Aclidinium/formoterol Fixed Dose Combination (FDC) low dose, twice per day
Experimental: Aclidinium/formoterol FDC high dose
24 week, double blind treatment period
Drug: Aclidinium Bromide/Formoterol Fumarate
Inhaled Aclidinium/formoterol FDC high dose, twice per day
Experimental: Aclidinium monotherapy 400 μg
24 week, double blind treatment period
Drug: Aclidinium Bromide
Inhaled Aclidinium 400 μg, twice per day
Active Comparator: Formoterol monotherapy 12 μg
24 week, double blind treatment period
Drug: Formoterol Fumarate
Inhaled Formoterol 12 μg, twice per day
Placebo Comparator: Placebo
24 week, double blind treatment period
Drug: Placebo
Inhaled dose-matched placebo, twice per day

  Eligibility

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

Inclusion Criteria:

  • Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing potential are allowed to enter the trial if they show to have a negative serum pregnancy test at the Screening Visit and are using, during the last two months before the Screening Visit, at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal Intrauterine Devices (IUDs), sexual abstinence or vasectomy of the partner.
  • Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years.
  • Patient with a clinical diagnosis of stable COPD according to the Global Initiative for Chronic Lung Disease "GOLD" Guidelines at the Screening Visit.
  • Patient whose FEV1/FVC (Forced Vital Capacity) at the Screening Visit measured between 10-15 minutes post inhalation of 400 micrograms of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%).
  • Patient with a diagnosis of moderate to severe COPD according to the GOLD Guidelines classification (stages II and III) at the Screening Visit: FEV1 measured between 10-15 minutes post inhalation of 400 micro grams 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 must be able to perform repeatable pulmonary function testing for FEV1 according to American Thoracic Society/European Respiratory Society "ATS/ERS" 2005 criteria at Screening Visit.
  • 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.

Exclusion Criteria:

  • History or current diagnosis of asthma.
  • Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Screening Visit.
  • Patient hospitalised for COPD exacerbation within 3 months prior to Screening Visit.
  • Clinically significant respiratory conditions defined as: Known active tuberculosis.
  • History of interstitial lung or massive pulmonary thromboembolic disease.

    • Pulmonary resection or lung volume reduction surgery within 12 months prior to Screening Visit.
    • History of lung transplantation.
    • History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener's syndrome, etc).
    • Known a1-antitrypsin deficiency.
  • Use of long-term oxygen therapy (≥ 15 hours/day).
  • Clinically significant cardiovascular conditions changes in the pharmacological therapy or other intervention within 12 months prior to Screening Visit, or newly diagnosed arrhythmia within the previous 3 months prior to Screening Visit.
  • Hospitalisation within 12 months prior to Screening Visit for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association.
  • Patient with interval corrected for heart rate "QTc" [calculated according to formulae (QTc=QT/RR1/2) > 470 msec as indicated in the centralised reading report assessed at Screening Visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462942

  Show 197 Study Locations
Sponsors and Collaborators
Almirall, S.A.
Forest Laboratories
Investigators
Study Director: Estrella Garcia, Ph.D. Almirall Global Clinical Operations & SR
  More Information

No publications provided

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01462942     History of Changes
Other Study ID Numbers: M/40464/30
Study First Received: October 26, 2011
Last Updated: February 8, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
South Korea: Korea Food and Drug Administration (KFDA)
Netherlands: Medicines Evaluation Board (MEB)
Belgium: Federal Agency for Medicinal Products and Health Products
Sweden: Institutional Review Board
Austria: Ethikkommission
Finland: Finnish Medicines Agency
Denmark: Ethics Committee
France: Institutional Ethical Committee
Czech Republic: Ethics Committee
Hungary: Scientific and Medical Research Council Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Russia: Ethics Committee
Slovak Republic: Ethics Committee
Ukraine: Ethics Committee
Romania: National Medicines Agency
South Africa: Human Research Ethics Committee
Bulgaria: Bulgarian Drug Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Almirall, S.A.:
COPD
Bronchitis
Chronic
Emphysema

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Bromides
Formoterol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 20, 2014