Efficacy and Safety of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass Exposure (EMERALD2)

August 16, 2022 updated by: Alejandra Ramirez Venegas, National Institute of Respiratory Diseases, Mexico

Efficacy and Safety of Indacaterol vs tiotropiuM on walkEd Distance From Baseline to 24 Weeks, in Women With modeRAte-severe COPD Secondary to Biomass Exposure: Randomized, Non Inferior, Open Label, Parallel Groups Clinical Trial

Chronic Obstructive Pulmonary Disease (COPD) is a disease that produces a high rate of social and economic health mortality and morbidity not only in our country but in the international field. The causes of this disease are well-known, being smoking what produces the major portion and the less (but no less important) frequently, biomass exposure (when people cook or warm the house). It is described that the COPD secondary to biomass exposure it is approximately a third half of all the cases in cohorts in patients with this disease.

Patients clinical affection with COPD by biomass is different from the one described in patients by smoking, being the most frequent the affection peripheral airway, with major proportion of symptoms such as dyspnoea, cough and expectoration (Phenotype "chronic bronchitis"), major frequency of exacerbations, as well as, major affection in the quality of life related to health and a minimum emphysema proportion.

Currently, there is a trend of paying attention on the outcomes based on patients, such as symptoms, quality of life and the risk prevention (exacerbations) as it is exposed in the strategy GOLD 2011. In that way, the bronchodilators use as a pillar in the COPD due to the utility for the exacerbation prevention, symptomatic improvement and in quality of life, predominating the utility of ultra long-acting bronchodilators, such as tiotropium. Recently, it is available more information on new bronchodilators as indacaterol, demonstrating at least no inferiority effect on FEV1, inspiring capacity (in fact, discreet superiority on the last one) and symptoms. A functional outcome clinically important is the capacity of exercising; Six-Minute Walk Test (6MWT) has been widely used to predict prognosis of COPD secondary to smoking. This test has not been evaluated in predicting the response to the specific treatment in patients with COPD secondary to biomass exposure.

Long-acting bronchodilators have been demonstrated a benefit to the patients with COPD by smoking, in the exercising capacity measured by 6MWT. There are several reasons why this outcome could be more relevant especially in this population: inhabit in rural areas where people walk long distances, most of them are women and they are usually in charge of all the housework.

Almost all the studies reported until now exclude patients with COPD due to some cause other than smoking. Due to the lack of information on this item and the particularities in this clinical and functional characteristics observed in this kind of patients, it is considered that these patients will be benefit with the use of ultra long-acting bronchodilators, to long period and, potentially can be observed additional benefits in the decrease of the frequency of the exacerbations and symptomatology as well as other important outcomes such as the functional, respiratory capacity among others.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of bronchodilators is an invaluable tool in COPD, in outcomes such as the exacerbation preventions, improvement of symptoms and exercise capacity and therefore in quality of life. However, as the efficacy as the security such as bronchodilators benefits that have only been characterized in patients with COPD secondary to smoking and it is only assumed benefits in COPD by other causes but without confirmation.

There are no national or international studies that describe the ultra long-acting bronchodilator's efficacy and security in COPD secondary to biomass exposure (BE).

The proportion of patients with COPD secondary by biomass exposure vary between 20-30%, depending on what kind of study and population, which is an important number leading to a great mortality, morbidity, social and economic, being important to characterize in a better way several relevant aspects such as the long period treatment response.

The proportion of patients with COPD by BE presents major proportion of phenotype "bronchitis" with major condition of peripheral airways level, with major proportion of dyspnoea and a decrease in the quality of life. It is precisely in these aspects where have been demonstrated benefits with ultra long-acting bronchodilators, as consequence, it is expected that this group of patients will be benefitted equal and perhaps in greater magnitude that those that are encompassed in the "emphysematous" phenotype.

Additionally, it is well described that the sub-diagnostic and sub-optimum treatment in patients with COPD in first level; because this kind of patients generally have low social-economic status and assuming that in the first level they will find the principal attention, it would be important to define major therapeutic alternatives in them.

As it was mentioned before, the exercising capacity is a functional outcome deeply studied with prognostic capacity in patients with COPD secondary to smoking; it is probably that it could be an outcome with major impact in this special group of patients (COPD secondary to biomass exposure), because they live, in general, in rural areas, heads of household and therefore, in terms of social rolls their functionality requirement is higher.

Finally, there is a finding well described the low adherence to patient's treatment with COPD, with various reasons including low economic resources and others such as devices of complicated application, multiple dosage, etc. Due to the fact that most of the people who suffer COPD by biomass exposure are women dedicated to housework all the day, it is probable that this kind of medicines (dosage once a day) as well as free treatment, is a strategy that improves the treatment adherence and could represent an improvement in the important outcomes in this devastating disease (functional capacity, quality of life, frequency of exacerbations, mortality).

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico, City, Mexico, 14080
        • Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age: >50
  2. Female (female eligibility criteria are: Women in no fertile age who are non pregnant and committed to use effective contraception).*See note.
  3. Relation FEV1/FVC less than 70% of predicted and the index obtained by the relation between the hours and the years of exposure (IEHL) more than 100 hrs/year (COPD of any grade or symptomatic).
  4. Be able to assist at all the study visits.
  5. Informed consent signed.
  6. Be able to perform the functional pulmonary test satisfactorily.
  7. Without any contraindication to perform any functional pulmonary test or exercise ( six-minute walking test.
  8. Stable COPD (No history of exacerbations in the last 6 weeks previous to the inclusion).
  9. In treatment with inhaled steroid at least 4 weeks before the inclusion.
  10. Smoking index less than 5.
  11. If the subject is chronic - degenerative diseases associated, these must be controlled.

  12. II-III functional class that allow her assist to the study visits.

    *Note: This problem predominates in WOMEN, as gender and roles (predominately in rural areas) who are the ones that cook and are exposed enough time to appear the comorbidity associated (COPD, headache, backache, conjunctival irritation, etc). That is why in this study were included only women because this is a problem of gender and poverty.

  13. Women with at least 5 years with amenorrhea (postmenopause).

Exclusion Criteria:

  1. History of:

    • Allergy or known intolerance to any of the bronchodilator drugs in the study.
    • Asthma, bronchiectasis (as tuberculosis, whooping cough or other infection sequelae associated in the clinic history), tuberculosis, COPD recent exacerbation or acute respiratory infection.
    • Cardiovascular disease recent (less than 3 months) that contraindicate the functional pulmonary test.
  2. Patients of childbearing age who do not agree to use effective methods of contraception.
  3. Patients with suspected cancer at any level.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indacaterol
Indacaterol 150 mcgr, one inhaled capsule, dose once daily, with dry powder inhaler device.
Drug: Indacaterol
Indacaterol, one inhales capsule, 150 mcgr, by dry powder dispositive
Other Names:
  • Onbrize
Active Comparator: Tiotropium
Tiotropium 18 mcgr, 1 inhaled capsule, dose once daily, with dry powder inhaler device
Drug: Tiotropium
Tiotropium 18 mcgr, one inhaled capsule, by dry powder inhaler handihaler
Other Names:
  • Spiriva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on the pulmonary function in functional capacity (walked meters on six minute walking test, 6MWT) from baseline to 6 month treatment.
Time Frame: Baseline, 1, 3 and 6 months
Changes on the pulmonary function in functional capacity
Baseline, 1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in exacerbations (rate exacerbations/patient/year). Total frequency of exacerbations, frequency of exacerbations that required hospitalization and exacerbations free period since the baseline up to 1, 3 and 6 month treatment.
Time Frame: Baseline, 1, 3 and 6 months
The exacerbation outcome will be measured according to the use of health resources and through the confirmation with the symptoms diary.
Baseline, 1, 3 and 6 months
Changes in pulmonary function (forced respiratory volume in first second (FEV1), forced vital capacity (FVC) and inspiratory capacity (IC))
Time Frame: Baseline, 1, 3 and 6 months
Changes in exacerbations
Baseline, 1, 3 and 6 months
Changes in quality of life (COPD Assessment Test (CAT) and Saint George Respiratory Questionnaire (SGRQ))
Time Frame: Baseline, 1, 3 and 6 months
Changes in quality of life
Baseline, 1, 3 and 6 months
Changes in dyspnea (modified Medical Research Council (mMRC) scale, Transition Dyspnea Index (TDI) questionnaires).
Time Frame: Baseline, 1, 3 and 6 months
Changes in dyspnea
Baseline, 1, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Respiratory Diseases, Mexico

Investigators

  • Principal Investigator: Alejandra Ramírez-Venegas, M.Cs., Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C 26-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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