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Trial record 70 of 185 for:    GLYCOPYRROLATE

Acute Effect of Aclidinium on Hyperinflation and Ventilation Inhomogeneity in Severe COPD Patients

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ClinicalTrials.gov Identifier: NCT02181023
Recruitment Status : Completed
First Posted : July 3, 2014
Last Update Posted : October 29, 2014
Sponsor:
Collaborator:
Fondazione Salvatore Maugeri
Information provided by (Responsible Party):
Pierachille Santus, University of Milan

Brief Summary:
  • Chronic Obstructive Pulmonary Disease (COPD) is characterized by lung hyperinflation and flow limitation. These physiopathological modifications are secondary to loss of elastic recoil and bronchial obstruction due to emphysema.
  • The cornerstone of COPD treatment is represented by inhaled beta-2 agonists and anticholinergics. The molecules of the latter classes can be characterized by short lasting action (few hours), long acting action (12 hours) or ultra long acting duration of action (24 hours).
  • For years the only anticholinergic (or antimuscarinic) drug other than those used by aerosol, was Tiotropium Bromide. Recently two new antimuscarinic agents have been launched on the market: glycopyrronium bromide (once daily) and aclidinium (twice daily).
  • The Single Breath Nitrogen Test is capable of identifying the pulmonary closing volume. The part of the curve that reflects lung ventilation inhomogeneity is the slope of phase III
  • For COPD patients, the most important characteristic for an inhalatory drug is a prompt action in order to give a quick relief from respiratory symptoms, in particular dyspnoea.
  • The objective of this study is to study the acute action of glycopyrronium and aclidinium in terms of reduction of hyperinflation, pulmonary specific resistances, lung volume distribution and dyspnoea at rest in severe COPD patients.
  • To our knowledge no study has explored these aspects before.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Aclidinium Bromide Drug: Glycopyrronium Bromide Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Acute Effect of Aclidinium on Hyperinflation and Lung Volume Distribution in Severe COPD Patients
Study Start Date : June 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aclidinium - Glycopyrronium
Patients will assume Aclidinium Bromide 322 dry powder by Genuair inhaler and Glycopyrronium 44 dry powder inhaler by Breezehaler inhaler (placebo) after 72 hours from inhalatory therapy washout (only short acting bronchodilators permitted). Then, after 72 hours of inhalatory drugs washout (only short acting bronchodilators permitted), they will receive Glycopyrronium Bromide 322 mcg via Breezehaler inhaler and Aclidinium Bromide 322 dry powder by Genuair inhaler (placebo).
Drug: Aclidinium Bromide
Aclidinium Bromide 322 mcg inhalation powder via Genuair inhaler (Eklira) Product by Almirall, S.A. Ronda General Mitre, 151. ES-08022 Barcelona, Spain
Other Names:
  • Eklira Genuair (UK)
  • Tudorza Pressair (US)
  • Bretaris Genuair (EU)

Drug: Glycopyrronium Bromide
Glycopyrronium Bromide 44 mcg dry powder (capsules) inhaled via Breezehaler inhaler, Seebri - product by Novartis Europharm Limited - Wimblehurst Road, Horsham, West Sussex, RH12 5AB; United Kingdom
Other Name: Seebri Breezhaler

Experimental: Glycopyrronium - Aclidinium
Patients will assume Glycopyrronium Bromide 44 mcg dry powder by Breezehaler inhaler and Aclidinium Bromide 322 dry powder by Genuair inhaler (placebo) after 72 hours of inhalatory therapy washout (only short acting bronchodilators permitted). Then, after 72 hours of inhalatory drugs washout (only short acting bronchodilators permitted) they will receive Aclidinium Bromide 322 mcg via Genuair inhaler and Glycopyrronium Bromide 44 mcg dry powder by Breezehaler inhaler (placebo).
Drug: Aclidinium Bromide
Aclidinium Bromide 322 mcg inhalation powder via Genuair inhaler (Eklira) Product by Almirall, S.A. Ronda General Mitre, 151. ES-08022 Barcelona, Spain
Other Names:
  • Eklira Genuair (UK)
  • Tudorza Pressair (US)
  • Bretaris Genuair (EU)

Drug: Glycopyrronium Bromide
Glycopyrronium Bromide 44 mcg dry powder (capsules) inhaled via Breezehaler inhaler, Seebri - product by Novartis Europharm Limited - Wimblehurst Road, Horsham, West Sussex, RH12 5AB; United Kingdom
Other Name: Seebri Breezhaler




Primary Outcome Measures :
  1. Residual Volume Variation from baseline [ Time Frame: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration ]
    Residual Volume is obtained by performing body plethysmography before study drug inhalation (baseline), and again 5, 15, 30,60 and 180 minutes after inhalation of study drug. The same subject will undergo the same evaluation in the second part of the study, after the crossing over

  2. Functional Residual Capacity variation from baseline [ Time Frame: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration ]
    Functional Residual Capacity (plethysmographic Intra Thoracic Gas Volume - ITGV) is obtained by performing body plethysmography before study drug inhalation (baseline), and again 5, 15, 30,60 and 180 minutes after inhalation of study drug. The same subject will undergo the same evaluation in the second part of the study, after the crossing over


Secondary Outcome Measures :
  1. Phase III slope variation from baseline [ Time Frame: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration ]
    Phase III slope is measured from the Single Breath Nitrogen Washout curve. It is measured at baseline (before study drug administration, and after 5, 15, 30, 60 and 180 minutes after study drug administration. The same patient will perform the same evaluation after drug crossing over

  2. Visual Analogical Scale (VAS) for Dyspnoea at rest variation from baseline [ Time Frame: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration ]
    Visual Analogical Scale (VAS) for Dyspnoea is obtained by asking the patients to evaluate the intensity of dyspnoea sensation at rest putting a sign in a scale that ranges from 0 to 10, being 10 the maximum dyspnoea discomfort and 0 the absence of dyspnoea sensation. The VAS scale will be performed before study drug inhalation (baseline), and again 5, 15, 30,60 and 180 minutes after inhalation of study drug. The same subject will undergo the same evaluation in the second part of the study, after the crossing over.

  3. Oxygen and Carbon Dioxide variation from baseline [ Time Frame: At baseline and 180 minutes after inhalation of study drug ]
    Partial Pressure of Oxygen (PaO2) and Partial Pressure of Carbon Dioxide (PaCO2) are obtained from arterial blood gas analysis before study drug inhalation and 180 minutes after drug inhalation. Patients will undergo the same evaluation after drug crossing over


Other Outcome Measures:
  1. Specific AirWay Resistances (sRAW) variation from baseline [ Time Frame: At baseline, 5, 15, 30, 60 and 180 minutes after study drug administration ]
    Specific AirWay Resistances (sRAW) are calculated from body plethysmography before study drug inhalation (baseline), and again 5, 15, 30,60 and 180 minutes after inhalation of study drug. The same subject will undergo the same evaluation in the second part of the study, after the crossing over



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signature of informed consent
  • COPD patients with age raging from 50 to 85 years old
  • Patients with at least a history of COPD of one year
  • COPD patients clinically stable in the last three months
  • COPD subjects with Forced Expiratory Volume at one second (FEV1)<50% of predicted value
  • COPD subjects with Residual Volume (RV) >125% predicted value
  • FEV1/Forced Vital Capacity (FVC) <88% (males) or <89% (females) of Low Levels of Normality (LLN)
  • COPD former or active smokers with at least a smoking history of 20 pack year

Exclusion Criteria:

  • Acute Bronchial Exacerbation at recruitment
  • Fertile women with age between 18 and 50 years old or with active period
  • Pregnancy
  • Subjects enrolled in other clinical trials or that have taken part in one of them in the month preceding the enrollment.
  • FEV1/FVC more than 70% of predicted value in basal conditions
  • FEV1 more than 70% of predicted value in basal conditions
  • Known deficit of alpha 1 antitrypsin
  • Subjects that underwent a Lung Volume Reduction Surgery (LVRS)
  • Subjects with known positivity to Human Immunodeficiency Virus (HIV)
  • Misuse of alcool or drugs
  • Lack of compliance in performing respiratory tests
  • Subjects not capable to follow the study prescriptions because of psychic disorders or language problems.
  • Long Term Oxygen Therapy with flows > 6 litres per minute (l/min) at rest

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): NCT02181023


Locations
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Italy
Fondazione Salvatore Maugeri
Milan, Italy, 20142
Sponsors and Collaborators
University of Milan
Fondazione Salvatore Maugeri
Investigators
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Study Director: Pierachille Santus, MD, PhD Università degli Studi di Milano-Pneumologia Riabilitativa-Fondazione Salvatore Maugeri-MILANO

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pierachille Santus, Head of Pulmonary Rehabilitation Unit, University of Milan
ClinicalTrials.gov Identifier: NCT02181023     History of Changes
Other Study ID Numbers: 960CEC
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014
Keywords provided by Pierachille Santus, University of Milan:
COPD
Hyperinflation
Aclidinium
Glycopyrronium
Volume distribution
Anticholinergic
Pharmacokinetics
Single Breath Nitrogen Test
Phase III
Additional relevant MeSH terms:
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Glycopyrrolate
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Bromides
Anticonvulsants
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs