Chronic Obstructive Pulmonary DiseasePhase 4NCT02547558
Pulmonary Gas Exchange Response to Indacaterol in COPD
A Phase 4 study testing Arterial blood gases, Cardiac Output and Vital signs in people with Chronic Obstructive Pulmonary Disease, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
To evaluate the pulmonary gas exchange response to a therapeutic high dose of inhaled indacaterol (300 mcg) in 20 outpatients with stable symptomatic COPD B and D GOLD 2011 groups. Measurements on a single day before and after 60 and 120 minutes of indacaterol will include arterial PO2, PaCO2 and pH. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Arterial blood gases, Cardiac Output and Vital signs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to Nov 2015
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients with COPD diagnosis according to GOLD 2011 criteria (VEF1/CVF less than 70%), groups B and D.
Who cannot join
- Conditions or serious comorbidities (i.e., asthma, bronchiectasis, lung cancer and/or cardiovascular diseases).
- Patients with frequent exacerbations (2 or more exacerbations in the past year).
- History of acute COPD exacerbation in the previous 3 months.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clínic
Barcelona, 08036
Isabel Blanco, MD, PhD, +34 649539835, iblanco2@clinic.ub.es
About this study
Official title: Pulmonary Gas Exchange Response to Indacaterol in Stable Symptomatic Chronic Obstructive Pulmonary Disease Patients
To evaluate the pulmonary gas exchange response to a therapeutic high dose of inhaled indacaterol (300 mcg) in 20 outpatients with stable symptomatic COPD B and D GOLD 2011 groups.
Measurements on a single day before and after 60 and 120 minutes of indacaterol will include arterial PO2, PaCO2 and pH. AaPO2; SaO2 (by pulse oximetry) and oxygen and carbon dioxide in exhaled breath, systemic arterial pressure and heart rate will also be measured/calculated. Cardiac output will be directly measured by bio-impedance.
Read the detailed description
The investigators hypothesize that in stable chronic obstructive pulmonary disease (COPD) patients the interaction between intrapulmonary and extrapulmonary determinants contributing to gas exchange abnormalities after indacaterol will ultimately preserve arterial oxygenation (primary end-point outcome).
The study will include 20 outpatients with diagnosis of stable COPD in GOLD 2011 groups B and D (10 each), without frequent exacerbations (≥2 in the previous year). Patients with a COPD exacerbation within 3 months of study, use of long-term oxygen therapy and associated conditions or serious comorbidities (i.e., asthma, bronchiectasis, lung cancer and/or cardiovascular diseases) will be excluded.
Each patient will be studied on a single day. All subjects will remain on their regular treatment for the study. Subjects will be required to withhold SABAs for at least 12 h and LABAs and theophylline for at least 24 h before study. During measurements, patients will breath room air and will be seated in an armchair. Measurements will be performed before and 60 and 120 min after a single dose administration of indacaterol Breezhaler@ 300 mcg (1 inhalation).
After ensuring steady-state conditions, as assessed by stability (± 5%) of both ventilatory and hemodynamic variables, and by the close agreement (within ± 5%) between duplicate of mixed expired and arterial oxygen and carbon dioxide, a set of duplicate measurements for each variable will be obtained at each time point.
Blood samples will be collected through a catheter inserted under local anesthesia into the radial artery. Samples of blood (5 ml) will be removed for measurement of arterial O2 tension (PaO2), CO2 tension (PaCO2) and pH; alveolar-arterial PO2 difference (A-a)DO2, oxygen saturation (SaO2), and VO2, VCO2, Ve, respiratory rate (f), systemic arterial pressure (Psa), and heart rate (HR) will be measured or calculated, as previously described.
Cardiac output will be directly measured by bio-impedance. Spirometry values will be recorded from the history records of each patient. All measurements will be performed in the Centre de Diagnòstic Respiratori (CDR), Servei de Pneumologia, Institut del Tòrax, Hospital Clínic, Barcelona.
The primary outcome will be the PaO2 change after indacaterol at each analysis time. Based on a previous study in stable severe COPD patients using nebulized salbutamol during convalescence of exacerbation, Polverino et al. calculated that for a significant PaO2 fall of the order of 8 mmHg, a sample of 6 subjects is needed; this number was increased to 20 patients to ensure better data.
Secondary outcomes were changes in PaCO2, pH, the calculated D(A-a)DO2 and the response of cardiac output.
Results will be expressed as mean (±SEM) or median (95% CI). The effects of indacaterol on each of the end-point variables will be assessed by one-way repeated measures analysis of variance (ANOVA). Paired t tests and Pearson's correlation tests will be used as appropriate. All significances will be set at p<0.05, without correction for multiple tests.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Arterial blood gases, Cardiac Output, Vital signs, Exhaled breath, Spirometry
- Keywords
- Indacaterol, Pulmonary gas exchange, Long-acting bronchodilators
- 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.
Arterial blood gasesProcedure or surgery
Also called PaO2, PaCO2, pH, AaPO2
Measured through radial arterial catheter
Cardiac OutputProcedure or surgery
Also called CO
Measured through bioimpedance: FloTrac pressure transducer (FloTrac sensor; Edwards Lifesciences) using the third-generation (3.01) FloTrac software for continuous CO display.
Vital signsProcedure or surgery
Also called Respiratory rate, Heart rate (HR), Systemic arterial pressure
As measured in clinical practice
Exhaled breathProcedure or surgery
Also called Oxygen, Carbon dioxide
Were recorded using a pneumotachograph (CPX/D; Med Graphics, St. Paul, MN, U.S.A.).
SpirometryProcedure or surgery
Also called FEV1, VFC
In a daily calibrated spirometer.
IndacaterolDrug
Also called Ultra long acting beta 2 agonist
Indacaterol Breezhaler@ 300 mcg (1 inhalation)
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol | Experimental | Drug:
-Indacaterol, inhaled, single dose, 300 mcg
Diagnostic Interventions:
* Arterial blood gases
* Cardiac output
* Vital signs
* Exhaled breath
* Spirometry Receives: Procedure: Arterial blood gases; Procedure: Cardiac Output; Procedure: Vital signs; Procedure: Exhaled breath; Procedure: Spirometry; Drug: Indacaterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PaO2 after indacaterol.
Measured: 60 and 120 minutes
Secondary outcomes (4)
Change in PaCO2 after indacaterol.
Measured: 60 and 120 minutes
Change in D(A-a)DO2 after indacaterol.
Measured: 60 and 120 minutes
Change in pH after indacaterol.
Measured: 60 and 120 minutes
Change in cardiac output after indacaterol.
Measured: 60 and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Blanco, Hospital Clinic of Barcelona
- Investigators
- Isabel Blanco, MD, PhD, Principal investigator, Hospital Clínic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547558
- Sponsor's protocol ID
- IndaEPOC
- Status last verified
- Sep 2015
- First submitted
- 4 Sep 2015
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Viegas CA, Ferrer A, Montserrat JM, Barbera JA, Roca J, Rodriguez-Roisin R. Ventilation-perfusion response after fenoterol in hypoxemic patients with stable COPD. Chest. 1996 Jul;110(1):71-7. doi: 10.1378/chest.110.1.71.
PubMed 8681669Pillet O, Manier G, Castaing Y. Anticholinergic versus beta 2-agonist on gas exchange in COPD: a comparative study in 15 patients. Monaldi Arch Chest Dis. 1998 Feb;53(1):3-8.
PubMed 9632900Whale CI, Sovani MP, Mortimer K, Oborne J, Cooper S, Harrison TW, Tattersfield AE. Effects of rac-albuterol on arterial blood gases in patients with stable hypercapnic chronic obstructive pulmonary disease. Br J Clin Pharmacol. 2006 Aug;62(2):153-7. doi: 10.1111/j.1365-2125.2006.02604.x.
PubMed 16842389Kew KM, Mavergames C, Walters JA. Long-acting beta2-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Oct 15;2013(10):CD010177. doi: 10.1002/14651858.CD010177.pub2.
PubMed 24127118Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis. Cochrane Database Syst Rev. 2014 Mar 26;2014(3):CD010844. doi: 10.1002/14651858.CD010844.pub2.
PubMed 24671923Khoukaz G, Gross NJ. Effects of salmeterol on arterial blood gases in patients with stable chronic obstructive pulmonary disease. Comparison with albuterol and ipratropium. Am J Respir Crit Care Med. 1999 Sep;160(3):1028-30. doi: 10.1164/ajrccm.160.3.9812117.
PubMed 10471636Zafar MA, Droege C, Foertsch M, Panos RJ. Update on ultra-long-acting beta agonists in chronic obstructive pulmonary disease. Expert Opin Investig Drugs. 2014 Dec;23(12):1687-701. doi: 10.1517/13543784.2014.942730. Epub 2014 Aug 19.
PubMed 25139313Roskell NS, Anzueto A, Hamilton A, Disse B, Becker K. Once-daily long-acting beta-agonists for chronic obstructive pulmonary disease: an indirect comparison of olodaterol and indacaterol. Int J Chron Obstruct Pulmon Dis. 2014 Jul 31;9:813-24. doi: 10.2147/COPD.S59673. eCollection 2014.
PubMed 25114521Cazzola M, Segreti A, Stirpe E, Puxeddu E, Ora J, Rogliani P, Matera MG. Effect of an additional dose of indacaterol in COPD patients under regular treatment with indacaterol. Respir Med. 2013 Jan;107(1):107-11. doi: 10.1016/j.rmed.2012.09.022. Epub 2012 Oct 18.
PubMed 23083839Gabrijelcic J, Casas A, Rabinovich RA, Roca J, Barbera JA, Chung KF, Rodriguez-Roisin R. Formoterol protects against platelet-activating factor-induced effects in asthma. Eur Respir J. 2004 Jan;23(1):71-5. doi: 10.1183/09031936.03.00057803.
PubMed 14738234Polverino E, Gomez FP, Manrique H, Soler N, Roca J, Barbera JA, Rodriguez-Roisin R. Gas exchange response to short-acting beta2-agonists in chronic obstructive pulmonary disease severe exacerbations. Am J Respir Crit Care Med. 2007 Aug 15;176(4):350-5. doi: 10.1164/rccm.200612-1864OC. Epub 2007 Apr 12.
PubMed 17431221
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Gas Exchange Response to Indacaterol in Stable Symptomatic Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT02547558
- Acronym / sponsor ID
- IndaEPOC
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Indacaterol, Pulmonary gas exchange, Long-acting bronchodilators
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 11 Sep 2015 (estimated)
- 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.
To evaluate the pulmonary gas exchange response to a therapeutic high dose of inhaled indacaterol (300 mcg) in 20 outpatients with stable symptomatic COPD B and D GOLD 2011 groups.
Measurements on a single day before and after 60 and 120 minutes of indacaterol will include arterial PO2, PaCO2 and pH. AaPO2; SaO2 (by pulse oximetry) and oxygen and carbon dioxide in exhaled breath, systemic arterial pressure and heart rate will also be measured/calculated. Cardiac output will be directly measured by bio-impedance.
Detailed description
The investigators hypothesize that in stable chronic obstructive pulmonary disease (COPD) patients the interaction between intrapulmonary and extrapulmonary determinants contributing to gas exchange abnormalities after indacaterol will ultimately preserve arterial oxygenation (primary end-point outcome).
The study will include 20 outpatients with diagnosis of stable COPD in GOLD 2011 groups B and D (10 each), without frequent exacerbations (≥2 in the previous year). Patients with a COPD exacerbation within 3 months of study, use of long-term oxygen therapy and associated conditions or serious comorbidities (i.e., asthma, bronchiectasis, lung cancer and/or cardiovascular diseases) will be excluded.
Each patient will be studied on a single day. All subjects will remain on their regular treatment for the study. Subjects will be required to withhold SABAs for at least 12 h and LABAs and theophylline for at least 24 h before study. During measurements, patients will breath room air and will be seated in an armchair. Measurements will be performed before and 60 and 120 min after a single dose administration of indacaterol Breezhaler@ 300 mcg (1 inhalation).
After ensuring steady-state conditions, as assessed by stability (± 5%) of both ventilatory and hemodynamic variables, and by the close agreement (within ± 5%) between duplicate of mixed expired and arterial oxygen and carbon dioxide, a set of duplicate measurements for each variable will be obtained at each time point.
Blood samples will be collected through a catheter inserted under local anesthesia into the radial artery. Samples of blood (5 ml) will be removed for measurement of arterial O2 tension (PaO2), CO2 tension (PaCO2) and pH; alveolar-arterial PO2 difference (A-a)DO2, oxygen saturation (SaO2), and VO2, VCO2, Ve, respiratory rate (f), systemic arterial pressure (Psa), and heart rate (HR) will be measured or calculated, as previously described.
Cardiac output will be directly measured by bio-impedance. Spirometry values will be recorded from the history records of each patient. All measurements will be performed in the Centre de Diagnòstic Respiratori (CDR), Servei de Pneumologia, Institut del Tòrax, Hospital Clínic, Barcelona.
The primary outcome will be the PaO2 change after indacaterol at each analysis time. Based on a previous study in stable severe COPD patients using nebulized salbutamol during convalescence of exacerbation, Polverino et al. calculated that for a significant PaO2 fall of the order of 8 mmHg, a sample of 6 subjects is needed; this number was increased to 20 patients to ensure better data.
Secondary outcomes were changes in PaCO2, pH, the calculated D(A-a)DO2 and the response of cardiac output.
Results will be expressed as mean (±SEM) or median (95% CI). The effects of indacaterol on each of the end-point variables will be assessed by one-way repeated measures analysis of variance (ANOVA). Paired t tests and Pearson's correlation tests will be used as appropriate. All significances will be set at p<0.05, without correction for multiple tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indacaterol | Experimental | Procedure: Arterial blood gases, Procedure: Cardiac Output, Procedure: Vital signs, Procedure: Exhaled breath, Procedure: Spirometry, Drug: IndacaterolDrug: -Indacaterol, inhaled, single dose, 300 mcg Diagnostic Interventions: * Arterial blood gases * Cardiac output * Vital signs * Exhaled breath * Spirometry |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients with COPD diagnosis according to GOLD 2011 criteria (VEF1/CVF less than 70%), groups B and D.
Key exclusion criteria (3 listed)
- Conditions or serious comorbidities (i.e., asthma, bronchiectasis, lung cancer and/or cardiovascular diseases).
- Patients with frequent exacerbations (2 or more exacerbations in the past year).
- History of acute COPD exacerbation in the previous 3 months.
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 |
|---|---|---|
| Arterial blood gasesAlso: PaO2, PaCO2, pH, AaPO2Measured through radial arterial catheter | Procedure or surgery | Indacaterol |
| Cardiac OutputAlso: COMeasured through bioimpedance: FloTrac pressure transducer (FloTrac sensor; Edwards Lifesciences) using the third-generation (3.01) FloTrac software for continuous CO display. | Procedure or surgery | Indacaterol |
| Vital signsAlso: Respiratory rate, Heart rate (HR), Systemic arterial pressureAs measured in clinical practice | Procedure or surgery | Indacaterol |
| Exhaled breathAlso: Oxygen, Carbon dioxideWere recorded using a pneumotachograph (CPX/D; Med Graphics, St. Paul, MN, U.S.A.). | Procedure or surgery | Indacaterol |
| SpirometryAlso: FEV1, VFCIn a daily calibrated spirometer. | Procedure or surgery | Indacaterol |
| IndacaterolAlso: Ultra long acting beta 2 agonistIndacaterol Breezhaler@ 300 mcg (1 inhalation) | Drug | Indacaterol |
Primary outcome
Change in PaO2 after indacaterol.
Time frame: 60 and 120 minutes
4 secondary outcomes
Change in PaCO2 after indacaterol.
Time frame: 60 and 120 minutes
Change in D(A-a)DO2 after indacaterol.
Time frame: 60 and 120 minutes
Change in pH after indacaterol.
Time frame: 60 and 120 minutes
Change in cardiac output after indacaterol.
Time frame: 60 and 120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
- Background: PubMed 8681669Viegas CA, Ferrer A, Montserrat JM, Barbera JA, Roca J, Rodriguez-Roisin R. Ventilation-perfusion response after fenoterol in hypoxemic patients with stable COPD. Chest. 1996 Jul;110(1):71-7. doi: 10.1378/chest.110.1.71.
- Background: PubMed 9632900Pillet O, Manier G, Castaing Y. Anticholinergic versus beta 2-agonist on gas exchange in COPD: a comparative study in 15 patients. Monaldi Arch Chest Dis. 1998 Feb;53(1):3-8.
- Background: PubMed 16842389Whale CI, Sovani MP, Mortimer K, Oborne J, Cooper S, Harrison TW, Tattersfield AE. Effects of rac-albuterol on arterial blood gases in patients with stable hypercapnic chronic obstructive pulmonary disease. Br J Clin Pharmacol. 2006 Aug;62(2):153-7. doi: 10.1111/j.1365-2125.2006.02604.x.
- Background: PubMed 24127118Kew KM, Mavergames C, Walters JA. Long-acting beta2-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Oct 15;2013(10):CD010177. doi: 10.1002/14651858.CD010177.pub2.
- Background: PubMed 24671923Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis. Cochrane Database Syst Rev. 2014 Mar 26;2014(3):CD010844. doi: 10.1002/14651858.CD010844.pub2.
- Background: PubMed 10471636Khoukaz G, Gross NJ. Effects of salmeterol on arterial blood gases in patients with stable chronic obstructive pulmonary disease. Comparison with albuterol and ipratropium. Am J Respir Crit Care Med. 1999 Sep;160(3):1028-30. doi: 10.1164/ajrccm.160.3.9812117.
- Background: PubMed 25139313Zafar MA, Droege C, Foertsch M, Panos RJ. Update on ultra-long-acting beta agonists in chronic obstructive pulmonary disease. Expert Opin Investig Drugs. 2014 Dec;23(12):1687-701. doi: 10.1517/13543784.2014.942730. Epub 2014 Aug 19.
- Background: PubMed 25114521Roskell NS, Anzueto A, Hamilton A, Disse B, Becker K. Once-daily long-acting beta-agonists for chronic obstructive pulmonary disease: an indirect comparison of olodaterol and indacaterol. Int J Chron Obstruct Pulmon Dis. 2014 Jul 31;9:813-24. doi: 10.2147/COPD.S59673. eCollection 2014.
- Background: PubMed 23083839Cazzola M, Segreti A, Stirpe E, Puxeddu E, Ora J, Rogliani P, Matera MG. Effect of an additional dose of indacaterol in COPD patients under regular treatment with indacaterol. Respir Med. 2013 Jan;107(1):107-11. doi: 10.1016/j.rmed.2012.09.022. Epub 2012 Oct 18.
- Background: PubMed 14738234Gabrijelcic J, Casas A, Rabinovich RA, Roca J, Barbera JA, Chung KF, Rodriguez-Roisin R. Formoterol protects against platelet-activating factor-induced effects in asthma. Eur Respir J. 2004 Jan;23(1):71-5. doi: 10.1183/09031936.03.00057803.
- Background: PubMed 17431221Polverino E, Gomez FP, Manrique H, Soler N, Roca J, Barbera JA, Rodriguez-Roisin R. Gas exchange response to short-acting beta2-agonists in chronic obstructive pulmonary disease severe exacerbations. Am J Respir Crit Care Med. 2007 Aug 15;176(4):350-5. doi: 10.1164/rccm.200612-1864OC. Epub 2007 Apr 12.
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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.
Isabel Blanco, MD, PhD principal investigator
Hospital Clínic
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 Arterial blood gases, Cardiac Output and Vital signs in people with Chronic Obstructive Pulmonary Disease, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Sep 2015. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel Blanco, MD, PhD (+34 649539835, IBLANCO2@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PaO2 after indacaterol. (time frame: 60 and 120 minutes). 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 NCT02547558, which also lists 11 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 11 Sep 2015.