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

NCT05506865 | Completed Phase 4 DMC

• 1 other identifier: C 26-12
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Keywords

COPD; Biomass

Outcome Measures

Primary Outcomes (1)

• Changes in quality of life (Saint George Respiratory Questionnaire (SGRQ))

  Changes in quality of life with SGRQ score.

  Baseline, 1, 3 and 6 months

Secondary Outcomes (6)

• Changes in quality of life (COPD Assessment Test (CAT)

  Baseline, 1, 3 and 6 months

• Changes in dyspnea (modified Medical Research Council (mMRC) score.

  Baseline, 1, 3 and 6 months

• Changes in dyspnea (Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) questionnaires).

  Baseline, 1, 3 and 6 months

• Changes in pulmonary function 1 (inspiratory capacity (IC))

  Baseline, 1, 3 and 6 months

• Changes in pulmonary function (forced respiratory volume in the first second (FEV1)

  Baseline, 1, 3 and 6 months

Study Arms (2)

Indacaterol

EXPERIMENTAL

Indacaterol 150 mcgr, one inhaled capsule, dose once daily, with dry powder inhaler device.

Drug: Indacaterol

Tiotropium

ACTIVE COMPARATOR

Tiotropium 18 mcgr, 1 inhaled capsule, dose once daily, 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 - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 50-80 years
• Female (female eligibility criteria are: Women in no fertile age who are non pregnant and committed to use effective contraception).\*See note.
• 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).
• Be able to assist at all the study visits.
• Informed consent signed.
• Be able to perform the functional pulmonary test satisfactorily.
• Without any contraindication to perform any functional pulmonary test or exercise ( six-minute walking test.
• Smoking index less than 5.
• If the subject is chronic - degenerative diseases associated, these must be controlled.
• 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.
• Women with at least 5 years with amenorrhea (postmenopause).

You may not qualify if:

• 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.
• Patients of childbearing age who do not agree to use effective methods of contraception.
• Patients with suspected cancer at any level.

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 (26)

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  PMID: 40169096 DERIVED

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: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: August 18, 2022
• Study Start: September 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 13, 2025

Record last verified: 2022-09

Locations

ME (1)