COPDPhase 4EMERALD2NCT05506865
Efficacy and Safety of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass Exposure
A Phase 4 study testing Indacaterol and Tiotropium in people with COPD, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- COPD
- What is being tested?
- Indacaterol and Tiotropium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2012to Jul 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- Without any contraindication to perform any functional pulmonary test or exercise ( six-minute walking test.
- Stable COPD (No history of exacerbations in the last 6 weeks previous to the inclusion).
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Mexico City, Mexico City, 14080
About this study
Official title: Efficacy and Safety of Indacaterol vs Tiotropium 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.
Read more
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.
Read the 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).
- Conditions
- COPD
- Being tested
- Indacaterol, Tiotropium
- Keywords
- COPD, Biomass
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndacaterolDrug
Also called Onbrize
Indacaterol, one inhales capsule, 150 mcgr, by dry powder dispositive
TiotropiumDrug
Also called Spiriva
Tiotropium 18 mcgr, one inhaled capsule, by dry powder inhaler handihaler
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol | Experimental | Indacaterol 150 mcgr, one inhaled capsule, dose once daily, with dry powder inhaler device. Receives: Drug: Indacaterol |
| Tiotropium | Active comparator | Tiotropium 18 mcgr, 1 inhaled capsule, dose once daily, with dry powder inhaler device Receives: Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quality of life (Saint George Respiratory Questionnaire (SGRQ))
Changes in quality of life with SGRQ score.
Measured: Baseline, 1, 3 and 6 months
Secondary outcomes (6)
Changes in quality of life (COPD Assessment Test (CAT)
Changes in quality of life with CAT score.
Measured: Baseline, 1, 3 and 6 months
Changes in dyspnea (modified Medical Research Council (mMRC) score.
Changes in dyspnea by mMRC score
Measured: Baseline, 1, 3 and 6 months
Changes in dyspnea (Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) questionnaires).
Changes in dyspnea with BDI/TDI scores.
Measured: Baseline, 1, 3 and 6 months
Changes in pulmonary function 1 (inspiratory capacity (IC))
Changes in IC in mL
Measured: Baseline, 1, 3 and 6 months
Changes in pulmonary function (forced respiratory volume in the first second (FEV1)
Changes in FEV1 in mL.
Measured: Baseline, 1, 3 and 6 months
Changes on the pulmonary function in functional capacity (walked meters on six minute walking test, 6MWT) from baseline to 6 month treatment.
Changes on the pulmonary function in functional capacity
Measured: Baseline, 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study startSep 2012
- Primary completionJan 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Respiratory Diseases, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alejandra Ramirez Venegas, National Institute of Respiratory Diseases, Mexico
- Investigators
- Alejandra Ramírez-Venegas, M.Cs., Principal investigator, Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506865
- Sponsor's protocol ID
- C 26-12
- Acronym
- EMERALD2
- Status last verified
- Sep 2022
- First submitted
- 6 Jul 2022
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11019457Torres-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.
PubMed 18625750Regalado 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.
PubMed 16799080Perez-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.
PubMed 8810608Barr RG, Bourbeau J, Camargo CA, Ram FS. Tiotropium for stable chronic obstructive pulmonary disease: A meta-analysis. Thorax. 2006 Oct;61(10):854-62. doi: 10.1136/thx.2006.063271. Epub 2006 Jul 14.
PubMed 16844726Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, Decramer M; UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008 Oct 9;359(15):1543-54. doi: 10.1056/NEJMoa0805800. Epub 2008 Oct 5.
PubMed 18836213Donohue JF, van Noord JA, Bateman ED, Langley SJ, Lee A, Witek TJ Jr, Kesten S, Towse L. A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. Chest. 2002 Jul;122(1):47-55. doi: 10.1378/chest.122.1.47.
PubMed 12114338Brusasco V, Hodder R, Miravitlles M, Korducki L, Towse L, Kesten S. Health outcomes following treatment for 6 months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax. 2006 Jan;61(1):91. doi: 10.1136/thx.2005.brusascolett. No abstract available.
PubMed 16396956Vogelmeier C, Kardos P, Harari S, Gans SJ, Stenglein S, Thirlwell J. Formoterol mono- and combination therapy with tiotropium in patients with COPD: a 6-month study. Respir Med. 2008 Nov;102(11):1511-20. doi: 10.1016/j.rmed.2008.07.020. Epub 2008 Sep 19.
PubMed 18804362van Noord JA, Aumann JL, Janssens E, Smeets JJ, Verhaert J, Disse B, Mueller A, Cornelissen PJ. Comparison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD. Eur Respir J. 2005 Aug;26(2):214-22. doi: 10.1183/09031936.05.00140404.
PubMed 16055868Rennard S, Bantje T, Centanni S, Chanez P, Chuchalin A, D'Urzo A, Kornmann O, Perry S, Jack D, Owen R, Higgins M. A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison. Respir Med. 2008 Jul;102(7):1033-44. doi: 10.1016/j.rmed.2008.02.001. Epub 2008 May 13.
PubMed 18479895Vogelmeier C, Hederer B, Glaab T, Schmidt H, Rutten-van Molken MP, Beeh KM, Rabe KF, Fabbri LM; POET-COPD Investigators. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med. 2011 Mar 24;364(12):1093-1103. doi: 10.1056/NEJMoa1008378.
PubMed 21428765Wedzicha JA, Seemungal TA. COPD exacerbations: defining their cause and prevention. Lancet. 2007 Sep 1;370(9589):786-96. doi: 10.1016/S0140-6736(07)61382-8.
PubMed 17765528Niewoehner DE, Rice K, Cote C, Paulson D, Cooper JA Jr, Korducki L, Cassino C, Kesten S. Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial. Ann Intern Med. 2005 Sep 6;143(5):317-26. doi: 10.7326/0003-4819-143-5-200509060-00007.
PubMed 16144890Caballero 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.
PubMed 17951621
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Indacaterol vs Tiotropium From Baseline to 24 Weeks, in Women With Moderate-severe COPD Secondary to Biomass Exposure: Randomized, Non Inferior, Open Label, Parallel Groups Clinical Trial
- ClinicalTrials.gov ID
- NCT05506865
- Acronym / sponsor ID
- EMERALD2 / C 26-12
- Conditions
- COPD
- Keywords
- COPD, Biomass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- National Institute of Respiratory Diseases, MexicoOther government
- Study start
- Sep 2012 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indacaterol | Experimental | Drug: IndacaterolIndacaterol 150 mcgr, one inhaled capsule, dose once daily, with dry powder inhaler device. |
| Tiotropium | Active comparator | Drug: TiotropiumTiotropium 18 mcgr, 1 inhaled capsule, dose once daily, with dry powder inhaler device |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (6 listed)
- History of:
- Patients of childbearing age who do not agree to use effective methods of contraception.
- Patients with suspected cancer at any level.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IndacaterolAlso: OnbrizeIndacaterol, one inhales capsule, 150 mcgr, by dry powder dispositive | Drug | Indacaterol |
| TiotropiumAlso: SpirivaTiotropium 18 mcgr, one inhaled capsule, by dry powder inhaler handihaler | Drug | Tiotropium |
Primary outcome
Changes in quality of life (Saint George Respiratory Questionnaire (SGRQ))
Time frame: Baseline, 1, 3 and 6 months
Changes in quality of life with SGRQ score.
6 secondary outcomes
Changes in quality of life (COPD Assessment Test (CAT)
Time frame: Baseline, 1, 3 and 6 months
Changes in dyspnea (modified Medical Research Council (mMRC) score.
Time frame: Baseline, 1, 3 and 6 months
Changes in dyspnea (Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) questionnaires).
Time frame: Baseline, 1, 3 and 6 months
Changes in pulmonary function 1 (inspiratory capacity (IC))
Time frame: Baseline, 1, 3 and 6 months
Changes in pulmonary function (forced respiratory volume in the first second (FEV1)
Time frame: Baseline, 1, 3 and 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Results publication: PubMed 11019457Bruce 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.
- Results publication: PubMed 18625750Torres-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.
- Results publication: PubMed 16799080Regalado 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.
- Results publication: PubMed 8810608Perez-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.
- Results publication: PubMed 16844726Barr RG, Bourbeau J, Camargo CA, Ram FS. Tiotropium for stable chronic obstructive pulmonary disease: A meta-analysis. Thorax. 2006 Oct;61(10):854-62. doi: 10.1136/thx.2006.063271. Epub 2006 Jul 14.
- Results publication: PubMed 18836213Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, Decramer M; UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008 Oct 9;359(15):1543-54. doi: 10.1056/NEJMoa0805800. Epub 2008 Oct 5.
- Results publication: PubMed 12114338Donohue JF, van Noord JA, Bateman ED, Langley SJ, Lee A, Witek TJ Jr, Kesten S, Towse L. A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. Chest. 2002 Jul;122(1):47-55. doi: 10.1378/chest.122.1.47.
- Results publication: PubMed 16396956Brusasco V, Hodder R, Miravitlles M, Korducki L, Towse L, Kesten S. Health outcomes following treatment for 6 months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax. 2006 Jan;61(1):91. doi: 10.1136/thx.2005.brusascolett. No abstract available.
- Results publication: PubMed 18804362Vogelmeier C, Kardos P, Harari S, Gans SJ, Stenglein S, Thirlwell J. Formoterol mono- and combination therapy with tiotropium in patients with COPD: a 6-month study. Respir Med. 2008 Nov;102(11):1511-20. doi: 10.1016/j.rmed.2008.07.020. Epub 2008 Sep 19.
- Results publication: PubMed 16055868van Noord JA, Aumann JL, Janssens E, Smeets JJ, Verhaert J, Disse B, Mueller A, Cornelissen PJ. Comparison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD. Eur Respir J. 2005 Aug;26(2):214-22. doi: 10.1183/09031936.05.00140404.
- Results publication: PubMed 18479895Rennard S, Bantje T, Centanni S, Chanez P, Chuchalin A, D'Urzo A, Kornmann O, Perry S, Jack D, Owen R, Higgins M. A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison. Respir Med. 2008 Jul;102(7):1033-44. doi: 10.1016/j.rmed.2008.02.001. Epub 2008 May 13.
- Results publication: PubMed 21428765Vogelmeier C, Hederer B, Glaab T, Schmidt H, Rutten-van Molken MP, Beeh KM, Rabe KF, Fabbri LM; POET-COPD Investigators. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med. 2011 Mar 24;364(12):1093-1103. doi: 10.1056/NEJMoa1008378.
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandra Ramírez-Venegas, M.Cs. principal investigator
Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indacaterol and Tiotropium in people with COPD, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quality of life (Saint George Respiratory Questionnaire (SGRQ)) (time frame: Baseline, 1, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05506865, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.