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

NCT02473237 | Completed Phase 4 DMC

• 1 other identifier: C 22-12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

COPD

Keywords

COPD; biomass

Outcome Measures

Primary Outcomes (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.

  baseline, 30, 60, 240 and 23:45 hours post dose of indacaterol vs tiotropium

Secondary Outcomes (4)

• 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.

  baseline, 30, 60, 240 and 23:45 hours post dose of indacaterol vs tiotropium

• 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.

  23:10 and 23:45 hours post dose of indacaterol vs tiotropium

• 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.

  baseline, 30, 60, 240 and 23:45 hours post dose of indacaterol vs tiotropium

• the frequency of adverse events presented during the study, between indacaterol vs tiotropium arm

  4 weeks

Study Arms (2)

indacaterol

EXPERIMENTAL

Indacaterol 150 mcgr, one inhaled capsule, dose once time on visit one, with dry powder inhaler device.

Drug: indacaterol

Tiotropium

ACTIVE COMPARATOR

Tiotropium 18 mcgr, 1 inhaled capsule, dose once time a Day, with dry powder inhaler device.

Drug: Tiotropium

Interventions

indacaterol DRUG

Indacaterol, one inhales capsule, 150 mcgr, by dry powder dispositive

Also known as: Onbrize

indacaterol

Tiotropium DRUG

Tiotropium 18 mcgr, one inhaled capsule, by dry powder inhaler handihaler

Also known as: Spiriva

Tiotropium

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or breastfeeding women
• Use of Methotrexate, gold salts, troleandomycin, cyclosporine, immunosuppressants,
• History of uncontrolled renal disease, liver disease, uncontrolled cardiovascular disease, metabolic disease, neurologic disease, hematologic disease, oncologic disease, or autoimmune disease.
• Any alteration in normal values of the following Laboratory test: liver test, PIE, Biochemistry tests.
• 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
• Patients that is under suspicion of having cancer.

Sponsors & Collaborators

• National Institute of Respiratory Diseases, Mexico: lead

Study Sites (1)

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (7)

• Perez-Padilla R, Regalado J, Vedal S, Pare P, Chapela R, Sansores R, Selman M. Exposure to biomass smoke and chronic airway disease in Mexican women. A case-control study. Am J Respir Crit Care Med. 1996 Sep;154(3 Pt 1):701-6. doi: 10.1164/ajrccm.154.3.8810608.

  PMID: 8810608 RESULT

• Bruce N, Perez-Padilla R, Albalak R. Indoor air pollution in developing countries: a major environmental and public health challenge. Bull World Health Organ. 2000;78(9):1078-92.

  PMID: 11019457 RESULT

• Torres-Duque C, Maldonado D, Perez-Padilla R, Ezzati M, Viegi G; Forum of International Respiratory Studies (FIRS) Task Force on Health Effects of Biomass Exposure. Biomass fuels and respiratory diseases: a review of the evidence. Proc Am Thorac Soc. 2008 Jul 15;5(5):577-90. doi: 10.1513/pats.200707-100RP.

  PMID: 18625750 RESULT

• Regalado J, Perez-Padilla R, Sansores R, Paramo Ramirez JI, Brauer M, Pare P, Vedal S. The effect of biomass burning on respiratory symptoms and lung function in rural Mexican women. Am J Respir Crit Care Med. 2006 Oct 15;174(8):901-5. doi: 10.1164/rccm.200503-479OC. Epub 2006 Jun 23.

  PMID: 16799080 RESULT

• Caballero A, Torres-Duque CA, Jaramillo C, Bolivar F, Sanabria F, Osorio P, Orduz C, Guevara DP, Maldonado D. Prevalence of COPD in five Colombian cities situated at low, medium, and high altitude (PREPOCOL study). Chest. 2008 Feb;133(2):343-9. doi: 10.1378/chest.07-1361. Epub 2007 Oct 20.

  PMID: 17951621 RESULT

• Ramirez-Venegas A, Sansores RH, Perez-Padilla R, Regalado J, Velazquez A, Sanchez C, Mayar ME. Survival of patients with chronic obstructive pulmonary disease due to biomass smoke and tobacco. Am J Respir Crit Care Med. 2006 Feb 15;173(4):393-7. doi: 10.1164/rccm.200504-568OC. Epub 2005 Dec 1.

  PMID: 16322646 RESULT

• Aaron SD, Vandemheen KL, Fergusson D, Maltais F, Bourbeau J, Goldstein R, Balter M, O'Donnell D, McIvor A, Sharma S, Bishop G, Anthony J, Cowie R, Field S, Hirsch A, Hernandez P, Rivington R, Road J, Hoffstein V, Hodder R, Marciniuk D, McCormack D, Fox G, Cox G, Prins HB, Ford G, Bleskie D, Doucette S, Mayers I, Chapman K, Zamel N, FitzGerald M; Canadian Thoracic Society/Canadian Respiratory Clinical Research Consortium. Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2007 Apr 17;146(8):545-55. doi: 10.7326/0003-4819-146-8-200704170-00152. Epub 2007 Feb 19.

  PMID: 17310045 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Alejandra Ramírez-Venegas, M.Cs.

  Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: June 16, 2015
• Study Start: April 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

ME (1)