Chronic Obstructive Pulmonary Disease (COPD)Phase 3ILLUMINATENCT01315249

QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing indacaterol and glycopyrronium (QVA149) and fluticasone/salmeterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 93 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: indacaterol and glycopyrronium (QVA149) and fluticasone/salmeterol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 523 participants
Where: 93 sitesin 9 countries
Study dates: Mar 2011to Mar 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Smoking history of at least 10 pack years
Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2009)
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >40% and < 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <70%

Who cannot join

Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer (within last 5 years)
Patients with a history of certain cardiovascular co-morbid conditions

Trial locations and contacts

93 sites in 9 countries.

Country

City, postcode or hospital

93 sites in 9 countries

Germany42 sites

Novartis Investigative Site
Aschaffenburg, 63739
Novartis Investigative Site
Bad Wörishofen, 86825
Novartis Investigative Site
Bamberg, 96049
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Berlin, Germany, 14050
Novartis Investigative Site
Berlin, 13057
Novartis Investigative Site
Berlin, 13086
Novartis Investigative Site
Berlin, 13507
Novartis Investigative Site
Berlin, 13581
Novartis Investigative Site
Berlin, 14050
Novartis Investigative Site
Berlin, D-12165
Novartis Investigative Site
Bielefeld, 33617
Novartis Investigative Site
Bochum, 44787
Novartis Investigative Site
Bonn, 53123
Novartis Investigative Site
Borstel, 23845
Novartis Investigative Site
Düren, 52349
Novartis Investigative Site
Eschwege, 37269
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Freudenberg, 57258
Novartis Investigative Site
Fulda, 36039
Novartis Investigative Site
Fürstenwalde, 15517
Novartis Investigative Site
Gelsenkirchen, 45879
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Gummersbach, 51643
Novartis Investigative Site
Güstrow, 18273
Novartis Investigative Site
Hagen, 59065
Novartis Investigative Site
Hamburg, 20253
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Hamburg, 20357
Novartis Investigative Site
Hanover, 30167
Novartis Investigative Site
Hildesheim, 31134
Novartis Investigative Site
Leipzig, Germany, 04207
Novartis Investigative Site
Lübeck, 23558
Novartis Investigative Site
München, 80539
Novartis Investigative Site
Oschersleben, 39387
Novartis Investigative Site
Ratingen, 40878
Novartis Investigative Site
Rheine, 48431
Novartis Investigative Site
Saarbrücken, Germany, 66111
Novartis Investigative Site
Schwerte, 58239
Novartis Investigative Site
Solingen, 42651
Novartis Investigative Site
Ulm, 89081
Novartis Investigative Site
Wissen, 57537

Other trials in Germany

Hungary9 sites

Novartis Investigative Site
Budapest, 1191
Novartis Investigative Site
Cegléd, Hungary, 2700
Novartis Investigative Site
Debrecen, Hungary, 4032
Novartis Investigative Site
Eger, 3300
Novartis Investigative Site
Gödöllő, 2100
Novartis Investigative Site
Mosonmagyaróvár, 9200
Novartis Investigative Site
Szarvas, Hungary, 5540
Novartis Investigative Site
Szeged, 6770
Novartis Investigative Site
Törökbálint, 2045

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Czechia8 sites

Novartis Investigative Site
Cvikov, Czech Republic, 471 54
Novartis Investigative Site
Jindřichův Hradec, Czech Republic, 377 01
Novartis Investigative Site
Kyjov, CZE, 697 70
Novartis Investigative Site
Mělník, Czech Republic, 276 01
Novartis Investigative Site
Pardubice, Czech Republic, 530 09
Novartis Investigative Site
Prague, Czech Republic, 108 00
Novartis Investigative Site
Prague, Czech Republic, 130 00
Novartis Investigative Site
Teplice, Czech Republic, 415 01

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Belgium7 sites

Novartis Investigative Site
Aalst, 9300
Novartis Investigative Site
Brussels, 1000
Novartis Investigative Site
Hasselt, 3500
Novartis Investigative Site
Jambes, 5100
Novartis Investigative Site
Jette, 1090
Novartis Investigative Site
Luxembourg, Luxembourg, 1210
Novartis Investigative Site
Malmedy, Belgium, 4960

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South Korea7 sites

Novartis Investigative Site
Daegu, 705-717
Novartis Investigative Site
Seoul, Seoul, 130-709
Novartis Investigative Site
Seoul, 100-032
Novartis Investigative Site
Seoul, 130-702
Novartis Investigative Site
Seoul, 143-729
Novartis Investigative Site
Seoul, 152-703
Novartis Investigative Site
Wŏnju, Gangwon-do, 220-701

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Spain7 sites

Novartis Investigative Site
Alicante, Alicante, 03114
Novartis Investigative Site
Barcelona, Catalonia, 08025
Novartis Investigative Site
Oviedo, Principality of Asturias, 33006
Novartis Investigative Site
Pamplona, Navarre, 31008
Novartis Investigative Site
Sabadell, Catalonia, 08208
Novartis Investigative Site
Sant Boi de Llobregat, Catalonia, 08830
Novartis Investigative Site
Valladolid, Valladolid, 47011

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Lithuania6 sites

Novartis Investigative Site
Alytus, LT-62114
Novartis Investigative Site
Kaunas, 44320
Novartis Investigative Site
Klaipėda, 92288
Novartis Investigative Site
Klaipėda, LT-92231
Novartis Investigative Site
Utena, LT-28151
Novartis Investigative Site
Vilnius, 06001

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Norway5 sites

Novartis Investigative Site
Ålesund, 6017
Novartis Investigative Site
Kongsvinger, 2212
Novartis Investigative Site
Skedsmokorset, 2020
Novartis Investigative Site
Stavanger, 4005
Novartis Investigative Site
Trondheim, 7006

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Estonia2 sites

Novartis Investigative Site
Tallinn, 13419
Novartis Investigative Site
Tartu, Estonia, 51014

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About this study

Official title: A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: indacaterol and glycopyrronium (QVA149), Placebo to fluticasone/salmeterol, fluticasone/salmeterol, Placebo to indacaterol and glycopyrronium (QVA149)
Keywords: QVA149, indacaterol, NVA237, COPD, fluticasone/salmeterol
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.

indacaterol and glycopyrronium (QVA149)Drug
QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily.
Placebo to fluticasone/salmeterolDrug
Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily.
fluticasone/salmeterolDrug
Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily.
Placebo to indacaterol and glycopyrronium (QVA149)Drug
Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily

Study groups in NCT01315249
Study group	Role	What they receive
QVA149	Experimental	Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol. Receives: Drug: indacaterol and glycopyrronium (QVA149); Drug: Placebo to fluticasone/salmeterol
fluticasone/salmeterol	Active comparator	Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149). Receives: Drug: fluticasone/salmeterol; Drug: Placebo to indacaterol and glycopyrronium (QVA149)

What is being measured

The primary outcome is the main question the study is designed to answer.

Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.
Measured: Week 26

Secondary outcomes (10)

Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours
Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model.
Measured: Week 12
Forced Vital Capacity at All-time Points (Week 12)
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model.
Measured: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12
Forced Vital Capacity at All-time Points (Week 26)
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model.
Measured: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26
Focal Score of the Transitional Dyspnea Index (TDI)
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement.
Measured: 12 weeks and 26 weeks
Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)
The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
Measured: 12 weeks and 26 weeks
Mean Change From Baseline in Daily Number of Puffs of Rescue Medication
Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.
Measured: Baseline, 12 weeks and 26 weeks
Change From Baseline in Symptom Scores Reported Using the Ediary
Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use.
Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked.
0 is the minimum score = "none" or "No symptoms" or "never" or "No"
1. = mild, a little
2. = moderate
3. = severe For the scale range provided, high values represent a worse outcome.
Measured: 12 weeks and 26 weeks
Inspiratory Capacity (IC) at All-time Points (12 Weeks)
After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
Measured: 12 weeks
Inspiratory Capacity (IC) at All-time Points (26 Weeks)
After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
Measured: 26 weeks
Number of Participants With Adverse Events
The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section.
Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Mar 2012

First posted15 Mar 2011 (estimated)
Study startMar 2011
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 523 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01315249
Sponsor's protocol ID: CQVA149A2313
Other IDs: 2010-023621-37
Acronym: ILLUMINATE
Status last verified: Jul 2013
First submitted: 11 Mar 2011
Last updated: 9 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Vogelmeier CF, Bateman ED, Pallante J, Alagappan VK, D'Andrea P, Chen H, Banerji D. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respir Med. 2013 Mar;1(1):51-60. doi: 10.1016/S2213-2600(12)70052-8. Epub 2012 Dec 6.
PubMed 24321804

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT01315249
Acronym / sponsor ID: ILLUMINATE / CQVA149A2313
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: QVA149, indacaterol, NVA237, COPD, fluticasone/salmeterol
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 523 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 15 Mar 2011 (estimated)
Results: Posted 9 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
QVA149	Experimental	Drug: indacaterol and glycopyrronium (QVA149), Drug: Placebo to fluticasone/salmeterolParticipants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
fluticasone/salmeterol	Active comparator	Drug: fluticasone/salmeterol, Drug: Placebo to indacaterol and glycopyrronium (QVA149)Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Smoking history of at least 10 pack years
Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2009)
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >40% and < 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <70%

Key exclusion criteria (7 listed)

Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
Patients with concomitant pulmonary disease
Patients with a history of asthma

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
indacaterol and glycopyrronium (QVA149)QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily.	Drug	QVA149
Placebo to fluticasone/salmeterolPlacebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily.	Drug	QVA149
fluticasone/salmeterolFluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily.	Drug	fluticasone/salmeterol
Placebo to indacaterol and glycopyrronium (QVA149)Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily	Drug	fluticasone/salmeterol

Primary outcome

Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12
Time frame: Week 26
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.

10 secondary outcomes

Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours
Time frame: Week 12
Forced Vital Capacity at All-time Points (Week 12)
Time frame: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12
Forced Vital Capacity at All-time Points (Week 26)
Time frame: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26
Focal Score of the Transitional Dyspnea Index (TDI)
Time frame: 12 weeks and 26 weeks
Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)
Time frame: 12 weeks and 26 weeks
Mean Change From Baseline in Daily Number of Puffs of Rescue Medication
Time frame: Baseline, 12 weeks and 26 weeks
Change From Baseline in Symptom Scores Reported Using the Ediary
Time frame: 12 weeks and 26 weeks
Inspiratory Capacity (IC) at All-time Points (12 Weeks)
Time frame: 12 weeks
Inspiratory Capacity (IC) at All-time Points (26 Weeks)
Time frame: 26 weeks
Number of Participants With Adverse Events
Time frame: 26 weeks

Results and safety

Results posted to the registry on 9 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QVA149	259	215
Fluticasone/Salmeterol	264	217

Primary outcome: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12

Time frame: Week 26. Least squares mean (Standard Error). Unit: liters

Measure	QVA149 n = 212	Fluticasone/Salmeterol n = 216
Value	1.69 (0.027)	1.56 (0.026)

Population analysed: The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QVA149	13 of 258 (5%)	73 of 258 (28.3%)	Not reported
Fluticasone/Salmeterol	14 of 264 (5.3%)	82 of 264 (31.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24321804Vogelmeier CF, Bateman ED, Pallante J, Alagappan VK, D'Andrea P, Chen H, Banerji D. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respir Med. 2013 Mar;1(1):51-60. doi: 10.1016/S2213-2600(12)70052-8. Epub 2012 Dec 6.

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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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

93 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 7 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 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in Germany, Hungary, Czechia, Belgium, South Korea and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (time frame: Week 26). 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 NCT01315249, which also lists 1 linked publication.

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 9 Aug 2013.