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Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01908140
First received: July 23, 2013
Last updated: September 29, 2014
Last verified: January 2014
  Purpose

The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Double-dummy, Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Twice-daily Aclidinium Bromide/Formoterol Fumarate Compared With Twice-daily Salmeterol/Fluticasone Propionate for 24 Weeks Treatment in Symptomatic Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Peak forced expiratory volume in one second (FEV1) at week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Transition Dyspnoea Index (TDI) focal score at week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment: 933
Study Start Date: September 2013
Study Completion Date: September 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aclidinium Bromide / Formoterol Fumarate
Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
Drug: Aclidinium Bromide / Formoterol Fumarate
Active Comparator: Salmeterol / Fluticasone propionate
Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
Drug: Salmeterol / Fluticasone
Other Names:
  • Seretide
  • Advair

  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 intra uterine devices (IUDs), sexual abstinence or vasectomy of the partner
  • Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years
  • Patients with a clinical diagnosis of COPD according to GOLD guidelines 2013, with a post-bronchodilator FEV1 <80%, and FEV1/FVC < 70% at Screening Visits
  • Symptomatic patients with a COPD assessment test (CAT) ≥10 at Screening and Randomisation Visits
  • Patient must be able to perform repeatable pulmonary function testing for FEV1 according to ATS/ERS 2005 criteria at Screening Visits
  • Patients 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
  • Development of a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit or during the run-in period
  • Clinically significant respiratory conditions
  • Type I or uncontrolled Type II diabetes, uncontrolled hypo- or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
  • Patients who, in the investigator's opinion, may need to start a pulmonary rehabilitation programme during the study and/or patients who started/finished it within 3 months prior to Screening Visit
  • Use of long-term oxygen therapy (≥15 hours/day)
  • Patients treated on daily basis with triple therapy (LABA+LAMA+ICS) within 4 weeks prior to the Screening Visit
  • Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers
  • Clinically significant cardiovascular conditions
  • Patient with clinically relevant abnormalities in the results of the clinical laboratory tests, ECG parameters or in the physical examination at the Screening Visit
  • Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
  • Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
  • Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis
  • History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer
  • Patient with any other serious or uncontrolled physical or mental dysfunction
  • Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment
  • Patient unlikely to be cooperative or that can't comply with the study procedures
  • Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Screening Visit
  • Patient who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication
  • Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study
  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: NCT01908140

  Show 126 Study Locations
Sponsors and Collaborators
Almirall, S.A.
Investigators
Study Director: Estrella Garcia, Ph.D. Almirall Global Clinical Operations
  More Information

No publications provided

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01908140     History of Changes
Other Study ID Numbers: M/40464/39, 2013-000116-14
Study First Received: July 23, 2013
Last Updated: September 29, 2014
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen (BASG) / Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES)
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada, Therapeutics Products Directorate
Czech Republic: State Institute for Drug Control
France: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Agenzia Italiana del Farmaco (AIFA)
Lithuania: State Medicines Control Agency of Lithuania
Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)
Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow Medycznych i Produktow Biobojczych
South Africa: Medicines Control Council, Registrar of Medicines
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on November 24, 2014