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Glittre ADL-test: Responsiveness to Acute Bronchodilation in Chronic Obstructive Pulmonary Disease (COPD) (Glittre)

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ClinicalTrials.gov Identifier: NCT03071731
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
Institut Universitaire de Cardiologie et Pneumologie de Québec
Information provided by (Responsible Party):
Didier Saey, Laval University

Brief Summary:
This project is aimed to assess the responsiveness of the Glittre ADL-test and the 1-Minute Sit-to-Stand test (1-Minute STST) to acute bronchodilation in patients with COPD. We also aim to investigate the physiological and perceptual response to bronchodilation of the Glittre ADL-test and the 1-minute STST. The specific objectives are 1)To measure the changes in time for completion of the Glittre ADL-test and the number of standing up during the 1-minute STST induced by a single dose of nebulized ipratropium bromide/salbutamol sulfate against those induced by a placebo in patients with moderate to severe COPD and 2)To compare in patients with moderate to severe COPD the CR (minute ventilation (VE), oxygen uptake (VO2), carbon dioxide production (VCO2) and heart rate) and symptomatic (dyspnea and leg fatigue perception) responses during the Glittre ADL-test and the 1-Minute STST following a single dose of ipratropium bromide/salbutamol sulfate or placebo. We suppose among others that the Glittre test completion time will be lesser, that the number of repetitions in the 1-Minute STST will be higher and symptoms intensity will be lesser among patients with COPD receiving bronchodilators.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Bronchodilators Drug: Placebos Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants receive one intervention (bronchodilation before performing a functional test) during the initial phase of the study and during the second phase of the study are evaluated in parallel after receiving a placebo or vice versa (random order)
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Randomization to decide on which visit the participant will receive the placebo will be generated by a software and managed by the main investigator. Bronchodilators and the placebo will be put in an aerosol of same shape and color so the participants and outcomes assessor won't be able to tell which one is which.
Primary Purpose: Other
Official Title: Glittre Activities of Daily Life-test: Responsiveness to Acute Bronchodilation in Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : April 13, 2017
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Bronchodilators
Nebulization of ipratropium bromide/salbutamol sulfate (500 µg/2.5 mg) before the administration of the Glittre ADL-test
Drug: Bronchodilators
Administration of a nebulized combination of bronchodilators before the administration of a functional test.
Other Name: ipratropium bromide; salbutamol sulfate

Drug: Placebos
Administration of a nebulized placebo before the administration of a functional test
Other Name: nebulized placebo

Placebo Comparator: Placebo
Nebulization of a placebo before the administration of the Glittre ADL-test
Drug: Bronchodilators
Administration of a nebulized combination of bronchodilators before the administration of a functional test.
Other Name: ipratropium bromide; salbutamol sulfate

Drug: Placebos
Administration of a nebulized placebo before the administration of a functional test
Other Name: nebulized placebo




Primary Outcome Measures :
  1. Glittre ADL-test time completion [ Time Frame: Between 2 and 12 minutes for each test; up to three days between the two tests ]
    Time to complete 5 laps as fast as possible


Secondary Outcome Measures :
  1. Perceptual variables [ Time Frame: Up to three days between the two administrations ]
    Dyspnea and fatigue in the legs at the end of the Glittre ADL-test

  2. Perceptual variables [ Time Frame: Up to three days between the two administrations ]
    Dyspnea and fatigue in the legs at the end of the 1-minute STST

  3. Breathing discomfort [ Time Frame: Up to three days between the two administrations ]
    Overall subjective experience of breathing discomfort after the Glittre ADL-test assessed with the Multidimensional Dyspnea Profile questionnaire

  4. Breathing discomfort [ Time Frame: Up to three days between the two administrations ]
    Overall subjective experience of breathing discomfort after the 1-minute STST assessed with the Multidimensional Dyspnea Profile questionnaire

  5. Accelerometry-subduration [ Time Frame: Up to three days between the two administrations ]
    Subduration (in seconds) in the Glittre ADL-test for each component, in each lap

  6. Accelerometry-steps [ Time Frame: Up to three days between the two administrations ]
    Number of steps in the Glittre ADL-test for each walking section, in each lap

  7. Accelerometry [ Time Frame: Up to three days between the two administrations ]
    Vertical and horizontal acceleration and deceleration (m/s) in the Glittre ADL-test for each component, in each lap

  8. Accelerometry [ Time Frame: Up to three days between the two administrations ]
    Vertical and horizontal acceleration and deceleration (m/s) in the 1-minute STST for each repetition.

  9. Hyperinflation [ Time Frame: Between 2 and 12 minutes for the IC measures at the beginning and at the end of the Glittre test, and up to 3 days before the 2nd assessment ]
    Change of IC between the beginning and end of the Glittre ADL-test completed after the administration of the placebo compared with the change of IC between the beginning and end of the Glittre test after the administration of the combination of bronchodilators

  10. Hyperinflation [ Time Frame: In a 5-minute time frame for the IC measures at the beginning and at the end of the 1-minute STST, and up to 3 days before the 2nd assessment ]
    Change of IC between the beginning and end of the 1-minute STST completed after the administration of the placebo compared with the change of IC between the beginning and end of the 1-minute STST after the administration of the combination of bronchodilators

  11. Physiological variable-ventilation [ Time Frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test ]
    Minute ventilation (VE; L/min) during the two Glittre ADL-test compared to the VE during an incremental cardiopulmonary maximal exercise test on bike.

  12. Physiological variable-ventilation [ Time Frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST ]
    Minute ventilation (VE; L/min) during the two 1-minute STST compared to the VE during an incremental cardiopulmonary maximal exercise test on bike.

  13. Physiological variable-ratio exchange rate [ Time Frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test ]
    Ratio exchange rate (RER) the two Glittre ADL-tests compared to RER during an incremental cardiopulmonary maximal exercise test on bike.

  14. Physiological variable-ratio exchange rate [ Time Frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST ]
    Ratio exchange rate (RER) the two 1-minute STST compared to RER during an incremental cardiopulmonary maximal exercise test on bike.

  15. Physiological variables-VO2 and VCO2 [ Time Frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test ]
    VO2 and VCO2 during the two Glittre ADL-tests compared to those during an incremental cardiopulmonary maximal exercise test on bike.

  16. Physiological variables-VO2 and VCO2 [ Time Frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST ]
    VO2 and VCO2 during the two 1-minute STST compared to those during an incremental cardiopulmonary maximal exercise test on bike.

  17. Physiological variable-HR [ Time Frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test ]
    Peak Heart rate (HR; beats/minute) during the two Glittre ADL-test compared to peak heart rate during an incremental cardiopulmonary maximal exercise test on bike.

  18. Physiological variable-HR [ Time Frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST ]
    Peak Heart rate (HR; beats/minute) during the two 1-minute STST compared to peak heart rate during an incremental cardiopulmonary maximal exercise test on bike.

  19. Physiological variable-RR [ Time Frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test ]
    Peak respiratory rate (breaths/min) during the two Glittre ADL-test compared to peak heart rate during an incremental cardiopulmonary maximal exercise test on bike.

  20. Physiological variable-RR [ Time Frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST ]
    Peak respiratory rate (breaths/min) during the two 1-minute STST compared to peak heart rate during an incremental cardiopulmonary maximal exercise test on bike.

  21. Number of repetitions 1-Minute STST [ Time Frame: About 2-3 minutes for test administration including instructions and demonstration; up to 3 days between both administration ]
    Number of full stand-up repetitions in the 1-Minute STST in both conditions (following the administration of the placebo and the bronchodilators)



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

Inclusion Criteria:

  • Diagnosis of moderate to severe COPD based on the GOLD spirometric classification
  • able to provide written informed consent
  • able to follow verbal directions for testing.

Exclusion Criteria:

  • diagnosed with cardiovascular, neurological or, neuromuscular conditions that could affect ability to perform the tests (e.g. stroke, knee osteoarthritis);
  • currently participating in a structured exercise or pulmonary rehabilitation program or been involved in pulmonary rehabilitation in the past 6 months;
  • experienced a COPD exacerbation in the past 6 weeks
  • receiving a daily dose > 10mg of oral Prednisone within the past 3 months
  • unable to walk 4 metres without use of a gait aid (e.g. walker, cane)
  • receiving oxygen supply

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): NCT03071731


Contacts
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Contact: Kim-Ly Bui, M.pht 418-656-8711 ext 2713 kim-ly.bui@criucpq.ulaval.ca

Locations
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Canada, Quebec
Centre de recherche-Institut Universitaire de Cardiologie et Pneumologie de Québec Recruiting
Quebec City, Quebec, Canada, G1V4G5
Contact: Kim-Ly Bui, M.pht    418-656-8711 ext 2713    kim-ly.bui@criucpq.ulaval.ca   
Contact: Didier Saey, Ph.D.    418-656-8711 ext 2614    didier.saey@rea.ulaval.ca   
Sponsors and Collaborators
Laval University
Institut Universitaire de Cardiologie et Pneumologie de Québec
Investigators
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Principal Investigator: Didier Saey, Ph.D. Centre de recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec

Publications:
Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Mölken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum in: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.

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Responsible Party: Didier Saey, Researcher-Associate Professor, Laval University
ClinicalTrials.gov Identifier: NCT03071731     History of Changes
Other Study ID Numbers: 2017-2739
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant data sets on characterization (muscle and pulmonary function, cardiopulmonary exercise testing) and medical history collected during the recruitment interview will be made available to other researchers after the end of the study, upon request. Data will be obtained through electronical denominalized files.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Didier Saey, Laval University:
Glittre
COPD
sit-to-stand
responsiveness
bronchodilation
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Albuterol
Bronchodilator Agents
Ipratropium
Anticonvulsants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents