Chronic Obstructive Pulmonary DiseasePhase 4FAVORNCT02125734

Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients

A Phase 4 study testing QVA149 and Tiotropium in people with Chronic Obstructive Pulmonary Disease and COPD, run by Novartis Pharmaceuticals at 18 sites in Germany.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease, COPD
What is being tested?: QVA149 and Tiotropium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 18 sitesGermany
Study dates: Apr 2014to Jan 2015
Phase: Phase 4
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

signed an Informed Consent Form
stable COPD according to current guidelines (GOLD 2013)
airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of <0.70 and a post-bronchodilator FEV1 of ≥30% and <80% of predicted normal values at Visit 2.
current or ex-smokers who have a smoking history of at least 10 pack years
Patients on stable tiotropium (18 µg/d) monotherapy for at least 8 weeks before Visit 1
Symptomatic patients defined as patients with CAT score ≥ 10 at Visit 1 (Screening).

Who cannot join

Pregnant or breast feeding mothers
Patients with conditions contraindicated for treatment
Patients with a history of clinically significant diseases
Patients who have a clinically significant renal disease
Patients with myocardial infarctions less than 6 months prior to study entry
Patients with recent (less than 1 year) history of NYHA Class III/IV left ventricular failure.

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Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or urinary retention
Patients with a history of malignancy of any organ system
Patients who have had a COPD exacerbation that required treatment with antibiotics, and/or systemic steroids (oral or intravenous) and/or hospitalization in the 6 weeks prior to Screening
Patients who have had a respiratory tract infection within 6 weeks prior to Screening
Patients with any history of asthma.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

Germany18 sites

Novartis Investigative Site
Berlin, 12203
Novartis Investigative Site
Berlin, 13057
Novartis Investigative Site
Bonn, 53119
Novartis Investigative Site
Frankfurt, 60318
Novartis Investigative Site
Frankfurt, 60389
Novartis Investigative Site
Garmisch-Partenkirchen, 82467
Novartis Investigative Site
Hanover, 30173
Novartis Investigative Site
Ibbenbüren, Rhineland-Palatinate, 49477
Novartis Investigative Site
Kassel, 34121
Novartis Investigative Site
Leipzig, 04275
Novartis Investigative Site
München, 80686
Novartis Investigative Site
Münster, 48147
Novartis Investigative Site
Neu-Isenburg, 63263
Novartis Investigative Site
Rheine, 48431
Novartis Investigative Site
Siegen, 57072
Novartis Investigative Site
Solingen, 42665
Novartis Investigative Site
Sonneberg, 96515
Novartis Investigative Site
Warendorf, 48231

Other trials in Germany

About this study

Official title: A Randomized, Multicenter, Open-label, Cross-over Study to Assess Lung Function and Patient Preference After a 4 Week Treatment Each With QVA149 vs. Tiotropium in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD) and Moderate to Severe Airflow Limitation Who Are on a Tiotropium Therapy (FAVOR Study)

The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung function. Similarly, this study aims to evaluate patient preference after experiencing both treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at screening despite being treated with tiotropium

Conditions: Chronic Obstructive Pulmonary Disease, COPD
Being tested: QVA149, Tiotropium
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.

QVA149Drug
Also called indacaterol maleate/glycoporromium bromide
QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day
TiotropiumDrug
Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day

Study groups in NCT02125734
Study group	Role	What they receive
Treatment sequence 1	Experimental	QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56 Receives: Drug: QVA149; Drug: Tiotropium
Treatment sequence 2	Experimental	Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56 Receives: Drug: QVA149; Drug: Tiotropium

What is being measured

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

Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation
Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Measured: week 4

Secondary outcomes (2)

Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.
Patient preference after experiencing both treatments. The patient's preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium.
Measured: 8 weeks
Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.
The investigator preference for future treatment suggestion after experiencing both treatments was assessed at the end of treatment period 2 with the Investigator Preference Questionnaire
Measured: 8 weeks

Timeline

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

Apr 2014Jan 2015

First posted29 Apr 2014 (estimated)
Study startApr 2014
Primary completionJan 2015
Study completionJan 2015

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.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 4
Primary purpose: Treatment
Intervention model: Crossover
Masking: None (open label)
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02125734
Sponsor's protocol ID: CQVA149ADE04
Other IDs: 2013-004223-37
Acronym: FAVOR
Status last verified: Mar 2017
First submitted: 24 Apr 2014
Last updated: 12 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Open-label, Cross-over Study to Assess Lung Function and Patient Preference After a 4 Week Treatment Each With QVA149 vs. Tiotropium in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD) and Moderate to Severe Airflow Limitation Who Are on a Tiotropium Therapy (FAVOR Study)
ClinicalTrials.gov ID: NCT02125734
Acronym / sponsor ID: FAVOR / CQVA149ADE04
Conditions: Chronic Obstructive Pulmonary Disease, COPD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 29 Apr 2014 (estimated)
Results: Posted 20 Jan 2016

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
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment sequence 1	Experimental	Drug: QVA149, Drug: TiotropiumQVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
Treatment sequence 2	Experimental	Drug: QVA149, Drug: TiotropiumTiotropium from day 1 to day 28 and QVA149 from day 29 to day 56

Who may qualify

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

Key inclusion criteria (6 listed)

signed an Informed Consent Form
stable COPD according to current guidelines (GOLD 2013)
airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of <0.70 and a post-bronchodilator FEV1 of ≥30% and <80% of predicted normal values at Visit 2.
current or ex-smokers who have a smoking history of at least 10 pack years
Patients on stable tiotropium (18 µg/d) monotherapy for at least 8 weeks before Visit 1

Key exclusion criteria (11 listed)

Pregnant or breast feeding mothers
Patients with conditions contraindicated for treatment
Patients with a history of clinically significant diseases
Patients who have a clinically significant renal disease
Patients with myocardial infarctions less than 6 months prior to study entry

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
QVA149Also: indacaterol maleate/glycoporromium bromideQVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day	Drug	Treatment sequence 1, Treatment sequence 2
TiotropiumTiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day	Drug	Treatment sequence 1, Treatment sequence 2

Primary outcome

Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation
Time frame: week 4
Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.

2 secondary outcomes

Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.
Time frame: 8 weeks
Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.
Time frame: 8 weeks

Results and safety

Results posted to the registry on 20 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence 1	40	40
Treatment Sequence 2	48	48

Primary outcome: Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation

Time frame: week 4. Least squares mean (95% Confidence Interval). Unit: Liters

Measure	QVA149 n = 87	Tiotropium n = 88
Value	1.676 (0.5709)	1.595 (0.6000)

QVA149 vs Tiotropium: Mean Difference (Net): 0.081 (95% CI 0.031 to 0.130), p = 0.0017, ANCOVA

Population analysed: Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QVA149	1 of 88 (1.1%)	28 of 88 (31.8%)	Not reported
Tiotropium	0 of 88 (0%)	21 of 88 (23.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Obstructive Pulmonary Disease

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)

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

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing QVA149 and Tiotropium in people with Chronic Obstructive Pulmonary Disease and COPD, run by Novartis Pharmaceuticals at 18 sites in Germany.

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 6 inclusion and 11 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 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Germany. 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?

Yes. Results are posted in the registry (first posted 20 Jan 2016). 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 One Second (FEV1) at 1 h Post-inhalation (time frame: week 4). 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 NCT02125734.

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 12 Apr 2017; AzTrials last refreshed its copy on 30 Oct 2026.