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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:
ClinicalTrials.gov Identifier:
NCT01908140
First Posted: July 25, 2013
Last Update Posted: March 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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
Chronic Obstructive Pulmonary Disease (COPD) Drug: Aclidinium Bromide / Formoterol Fumarate Drug: Salmeterol / Fluticasone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 AstraZeneca:

Primary Outcome Measures:
  • Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 [ Time Frame: At Week 24 ]
    Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration


Secondary Outcome Measures:
  • Transition Dyspnoea Index (TDI) Focal Score at Week 24 [ Time Frame: At Week 24 ]
    The TDI includes the same 3 categories as BDI and 7 ratings indicating the magnitude of the change from baseline in each category: from -3 ("major deterioration") to zero ("no change") to +3 ("major improvement"). Category scores are added to compute the Focal Score (from -9 to 9)


Enrollment: 933
Study Start Date: September 2013
Study Completion Date: August 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male or non-pregnant, non-lactating female aged ≥40.
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908140


  Show 126 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Esther Garcia, Ph.D. Global Medicines Development
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01908140     History of Changes
Other Study ID Numbers: M/40464/39
2013-000116-14 ( EudraCT Number )
First Submitted: July 23, 2013
First Posted: July 25, 2013
Results First Submitted: August 6, 2015
Results First Posted: March 7, 2016
Last Update Posted: March 7, 2016
Last Verified: February 2016

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