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Efficacy in Walked Distance of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass (EMERALD) (EMERAL)

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ClinicalTrials.gov Identifier: NCT02473237
Recruitment Status : Completed
First Posted : June 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Alejandra Ramirez Venegas, National Institute of Respiratory Diseases, Mexico

Brief Summary:

Chronic Obstructive Pulmonary Disease (COPD) secondary to biomass exposure constitutes a chronic respiratory condition frequently excluded from large clinical trials. Biomass exposure COPD have some histopathologic, clinical, radiological and functional differences with tobacco smoke COPD. However, until now, there are no evidence in this patients about the clinical response to bronchodilators routinely used in tobacco smoke COPD.

Primary objective: To compare changes in walked meters from baseline on six minute walking test (6MWT) to 23:45 hours after one dose of indacaterol vs tiotropium in patients with moderate to severe COPD secondary to biomass exposure.

Secondary objectives: To compare changes in pulmonary function (inspiratory capacity, Forced Expiratory Volume in first second (FEV1) milliliters, FEV1 "through") from baseline (-10 minutes) to 23:45 hours after one dose of indacaterol vs tiotropium in patients with moderate to severe COPD secondary to biomass exposure.

This will be an open label study, double blinded, cross over and conducted at specialized respiratory care center (National Institute of Respiratory Diseases), to compare the acute effects of ultra long acting bronchodilators used in tobacco smoke exposure COPD. Unicentric study.

Ethics Committee approbation: C 22-12


Condition or disease Intervention/treatment Phase
COPD Drug: indacaterol Drug: Tiotropium Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Acute Effects on Walked Distance froM basEline and Post Dose of indacateRol vs Tiotropium in Women With modeRAte to Severe COPD Secondary to Biomass Exposure: Open Label Crossover Clinical Trial
Study Start Date : April 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: indacaterol
Indacaterol 150 mcgr, one inhaled capsule, dose once time on visit one, with dry powder inhaler device.
Drug: indacaterol
Indacaterol, one inhales capsule, 150 mcgr, by dry powder dispositive
Other Name: Onbrize

Active Comparator: Tiotropium
Tiotropium 18 mcgr, 1 inhaled capsule, dose once time a Day, with dry powder inhaler device.
Drug: Tiotropium
Tiotropium 18 mcgr, one inhaled capsule, by dry powder inhaler handihaler
Other Name: Spiriva




Primary Outcome Measures :
  1. changes in walked meters on six minute walking test (6MWT) from baseline to 23:45 hours after one dose of indacaterol vs tiotropium in patients with moderate to severe COPD secondary to biomass exposure. [ Time Frame: baseline, 30, 60, 240 and 23:45 hours post dose of indacaterol vs tiotropium ]

Secondary Outcome Measures :
  1. changes in Inspiratory Capacity (IC) from baseline (-10 minutes) to 30, 60, 240 minutes and 23:45 hours post dose of Indacaterol (150 µg) vs Tiotropium (18µg) in patients with with biomass smoke COPD. [ Time Frame: baseline, 30, 60, 240 and 23:45 hours post dose of indacaterol vs tiotropium ]
  2. the 'trough' FEV1 (mean of values at 23 h 10 min and 23 h 45 min post-dose) after one dose of indacaterol vs tiotropium in patients with COPD secondary to biomass exposure. [ Time Frame: 23:10 and 23:45 hours post dose of indacaterol vs tiotropium ]
  3. changes in dyspnea perception by using the Borg scale from baseline (-10 minutes) to 30, 60, 240 min and 23:45 hours post dose of Indacaterol (150 µg) vs Tiotropium (18 µg) in patients with COPD secondary to biomass exposure. [ Time Frame: baseline, 30, 60, 240 and 23:45 hours post dose of indacaterol vs tiotropium ]
  4. the frequency of adverse events presented during the study, between indacaterol vs tiotropium arm [ Time Frame: 4 weeks ]
    non serious adverse events; serious adverse events.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Mexican patients at the COPD outpatient clinic
  2. Age: >50
  3. Female (female eligibility criteria are: Women in no fertile age who are non pregnant and committed to use effective contraception).
  4. FEV1 less than 80% of predicted and risk of exacerbation (GOLD update 2011) B, C or D
  5. Women with COPD diagnostic with biomass exposition (defined with an Hours/years index >200 hr/y).
  6. Be Able to assist at the different visits during the study.
  7. Be Able to performed the spirometry
  8. Patients without contraindications to perform the six-minute walk test.
  9. Informed consent signed.
  10. No history of exacerbations in the last 6 weeks previous to the inclusion.
  11. With amenorrhea history more than a year duration.

Exclusion Criteria:

  1. Pregnant or breastfeeding women
  2. Use of Methotrexate, gold salts, troleandomycin, cyclosporine, immunosuppressants,
  3. History of uncontrolled renal disease, liver disease, uncontrolled cardiovascular disease, metabolic disease, neurologic disease, hematologic disease, oncologic disease, or autoimmune disease.
  4. Any alteration in normal values of the following Laboratory test: liver test, PIE, Biochemistry tests.
  5. History of asthma, bronchiectases, tuberculosis, recent respiratory tract infection, were hospitalized for a COPD exacerbation (6 weeks prior to visit 1), any significant pulmonary disease o cardiovascular abnormality
  6. Patients that is under suspicion of having cancer.

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): NCT02473237


Locations
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Mexico
Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Mexico, City, Mexico, 14080
Sponsors and Collaborators
National Institute of Respiratory Diseases, Mexico
Investigators
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Principal Investigator: Alejandra Ramírez-Venegas, M.Cs. Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Publications of Results:

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Responsible Party: Alejandra Ramirez Venegas, MD, National Institute of Respiratory Diseases, Mexico
ClinicalTrials.gov Identifier: NCT02473237     History of Changes
Other Study ID Numbers: C 22-12
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015
Keywords provided by Alejandra Ramirez Venegas, National Institute of Respiratory Diseases, Mexico:
COPD
biomass
Additional relevant MeSH terms:
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Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action