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Effect of Aclidinium/Formoterol on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe COPD Patients (ACTIVATE)

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ClinicalTrials.gov Identifier: NCT02424344
Recruitment Status : Completed
First Posted : April 23, 2015
Results First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Menarini Group
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The present study is planned to evaluate the effect of the aclidinium bromide/formoterol fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in patients with moderate to severe COPD. Additionally, the effect of the behavioural intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both on the exercise endurance and the physical activity.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Aclidinium/Formoterol Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose, Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Assess the Effect of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combination on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : April 27, 2015
Actual Primary Completion Date : July 25, 2016
Actual Study Completion Date : July 25, 2016


Arm Intervention/treatment
Experimental: Aclidinium Bromide/Formoterol Fumarate FDC 400/12μg
8 weeks, double blind treatment period
Drug: Aclidinium/Formoterol
Aclidinium bromide/Formoterol fumarate FDC 400/12μg dry powder for oral inhalation twice daily via Genuair inhaler

Placebo Comparator: Placebo to Aclidinium/Formoterol
8 weeks, double blind treatment period
Drug: Placebo
Dose-matched placebo dry powder for oral inhalation twice daily via Genuair inhaler




Primary Outcome Measures :
  1. Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment [ Time Frame: Baseline and Week 4 ]
    Baseline values in FRC were defined as the corresponding values just before randomization on Day 1 of treatment (Week 0). Trough values were obtained prior to study drug administration.


Secondary Outcome Measures :
  1. Change From Baseline in Endurance Time (ET) During Constant Work Rate Cycle Ergometry at Week 8 [ Time Frame: Baseline to Week 8 ]

    The ET was the time from the increase in work rate to 75% Wmax to the point of symptom limitation.

    Baseline measurements were taken prior to the IP dose on Day 1. Measurements at Week 8 were taken at 3 hours post-dose. Participants underwent a behavioural intervention (consisting of a telecoaching programme to enhance physical activity) between Week 4 and Week 8.


  2. Percentage of Inactive Patients (Mean of <6000 Steps Per Day) at Week 8 [ Time Frame: Week 8 ]

    Physical activity was assessed by means of measurement of activity parameters (e.g. number of steps) through a Dynaport MoveMonitor and completion of the Daily ProActive Physical Activity in chronic obstructive pulmonary disease (COPD) questionnaire.

    Compliant criterion based on at least 8 hours per day, and at least 3 days per week. Participants underwent a behavioural intervention (consisting of a telecoaching programme to enhance physical activity) between Week 4 and Week 8.

    Baseline was defined as mean of steps/day assessed during the week before the randomisation visit.




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Ages Eligible for Study:   40 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and non-pregnant, non-lactating females aged ≥ 40.
  2. Patients with a clinical diagnosis of COPD according to GOLD guidelines 2014, with a post bronchodilator FEV1 ≥ 40% and < 80% of the predicted value and FEV1/FVC < 70% at Visit 1.
  3. Functional residual capacity (FRC) measured by body plethysmography at Visit 1 ≥ 120% of predicted value.
  4. Patients with modified Medical Research Council dyspnea scale (mMRC) ≥ 2 at Visit 1.
  5. Current or former cigarette smokers with a smoking history of at least 10 pack-years at Visit 1
  6. Patients willing to participate in the telecoaching program during the four last weeks and to enhance their physical activity
  7. Patients who understand and are able to follow the study procedures, are cooperative 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. Any respiratory tract infection (including upper respiratory tract) or COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period.
  3. Patients who have been hospitalised for an acute COPD exacerbation within 3 months prior to Visit 1 or during the run-in period.
  4. Clinically significant respiratory conditions other than COPD.
  5. Use of long-term oxygen therapy (≥ 15 hours/day).
  6. Oxygen saturation ≤ 85% as measured by pulse oximetry during exercise testing at Visit 1, Visit 2 or Visit 3 prior to randomisation.
  7. Patients with a Body Mass Index (BMI) ≥ 40kg/m2.
  8. Patient who may need to start a pulmonary rehabilitation program during the study and/or who started/finished it within 3 months prior to Visit 1 or during the run-in period.
  9. Patients with clinically significant cardiovascular conditions.
  10. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension.
  11. Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.
  12. Patients with clinically relevant abnormalities in the results of the blood pressure, ECG, or physical examination at Visit 1.
  13. Patients with any serious or uncontrolled physical or mental dysfunction that could place the patient at higher risk derived from his/her participation in the study or could confound the results
  14. Patients with conditions other than COPD that may contribute to dyspnoea and exercise limitation or with contraindications to clinical exercise testing according to ATS recommendations for CPET
  15. Patients with other relevant comorbidities that make the patient nor suitable to follow-up study procedures and/or could affect physical activity
  16. Patients who cycled < 2 minutes or > 15 minutes during the constant work-rate exercise tests conducted at Visit 2 (Run-in Visit) or at Visit 3 even after adjustment of the work load.
  17. Patients with history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
  18. Patients for whom the use of anticholinergic drugs is contraindicated (acute urinary retention, symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma)
  19. Patients unable to properly use a multidose dry powder inhaler or a pressurized metered-dose inhaler (pMDI).
  20. Patients using any prohibited medication (including IMP within 30 days (or 6 half-lives, whichever is longer) before Visit 1) or who have not undergone the required washout period.
  21. 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).
  22. Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers, sleep apnea).
  23. Patients unable to give their consent, or patients of consenting age but under guardianship, or vulnerable patients

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): NCT02424344


Locations
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Canada, Ontario
Research Site
Hamilton, Ontario, Canada, L8N 3Z5
Research Site
Kingston, Ontario, Canada, K7L 2V7
Canada, Quebec
Research Site
Sainte Foy, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
Research Site
Saskatoon, Saskatchewan, Canada, S7N 0W8
Germany
Research Site
Berlin, Germany, 10117
Research Site
Berlin, Germany, 10717
Research Site
Berlin, Germany, 10787
Research Site
Berlin, Germany, 10969
Research Site
Berlin, Germany, 13086
Research Site
Dortmund, Germany, 44263
Research Site
Frankfurt, Germany, 60596
Research Site
Großhansdorf, Germany, 22927
Research Site
Hamburg, Germany, 20253
Research Site
Hamburg, Germany, 20354
Research Site
Hannover, Germany, 30173
Research Site
Jena, Germany, 7740
Research Site
Lübeck, Germany, 23552
Research Site
München, Germany, 80331
Research Site
Wiesbaden, Germany, 65187
Hungary
Research Site
Budapest, Hungary, 1125
Research Site
Deszk, Hungary, 6772
Research Site
Nyíregyháza, Hungary, 4400
Research Site
Törökbálint, Hungary, 2045
Spain
Research Site
Alicante, Spain, 03004
Research Site
Cáceres, Spain, 10003
Research Site
Madrid, Spain, 28046
Sponsors and Collaborators
AstraZeneca
Menarini Group
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02424344    
Other Study ID Numbers: D6570C00001
M-40464-33 ( Other Identifier: Clinical Trial Protocol Code )
2014-005318-50 ( EudraCT Number )
First Posted: April 23, 2015    Key Record Dates
Results First Posted: October 9, 2018
Last Update Posted: October 9, 2018
Last Verified: December 2017
Keywords provided by AstraZeneca:
COPD
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action