Chronic Obstructive Pulmonary DiseasePhase 3BEACONNCT01529632
Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing QVA149, NVA237 and QAB149 in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 26 sites in 5 countries.
Trial summary
The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- QVA149, NVA237 and QAB149
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 193 participants
- Where
- 26 sitesin 5 countries
- Study dates
- May 2012to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female adults aged ≥ 40 yrs
- Smoking history of at least 10 pack years
- Diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2010)
- Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Who cannot join
- 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
- Patients with a history of certain cardiovascular co-morbid conditions
- Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
Show all 9Show fewer
- Patients in the active phase of a supervised pulmonary rehabilitation program
- Patients contraindicated for inhaled anticholinergic agents and β2 agonists
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
26 sites in 5 countries.
26 sites in 5 countries
Netherlands8 sites
Novartis Investigative Site
Almelo, Netherlands, 7609 PP
Novartis Investigative Site
Eindhoven, 5623 EJ
Novartis Investigative Site
Harderwijk, Netherlands, 3840 AC
Novartis Investigative Site
Heerlen, Netherlands, 6419 PC
Novartis Investigative Site
Hengelo, 7555 DL
Novartis Investigative Site
Sittard-Geleen, 6162 BG
Novartis Investigative Site
Tubbergen, 7651 JH
Novartis Investigative Site
Veldhoven, 5504 DB
Denmark5 sites
Novartis Investigative Site
Aalborg, Denmark, DK-9100
Novartis Investigative Site
Aarhus, DK-8000
Novartis Investigative Site
Copenhagen NV, DK-2400
Novartis Investigative Site
Hvidovre, Denmark, DK-2650
Novartis Investigative Site
Odense C, DK-5000
Norway5 sites
Novartis Investigative Site
Kløfta, 2040
Novartis Investigative Site
Kongsvinger, 2212
Novartis Investigative Site
Skedsmokorset, 2020
Novartis Investigative Site
Stavanger, 4005
Novartis Investigative Site
Trondheim, 7006
Austria4 sites
Novartis Investigative Site
Feldbach, Austria, 8330
Novartis Investigative Site
Grieskirchen, Austria, 4710
Novartis Investigative Site
Linz, Austria, 4020
Novartis Investigative Site
Wels, Austria, 4600
Sweden4 sites
Novartis Investigative Site
Gothenburg, 412 63
Novartis Investigative Site
Stockholm, 111 57
Novartis Investigative Site
Stockholm, S-171 76
Novartis Investigative Site
Uddevalla, 451 50
About this study
Official title: A Study to Compare the Efficacy and Safety of Once Daily QVA149 Versus the Once Daily Concurrent Administration of QAB149 Plus NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).
Read the detailed description
The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- QVA149, NVA237, QAB149, Placebo
- Keywords
- chronic obstructive pulmonary disease, COPD, QVA149, QAB149, NVA237, indacaterol, glycopyrronium bromide
- 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
QVA149 110/50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily
NVA237Drug
NVA237 50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily
QAB149Drug
QAB149 150 ug supplied as capsules in blister packs for inhalation via SDDPI , once daily
PlaceboDrug
Placebo capsules provided in blister packs for inhalation via SDDPI, once daily
| Study group | Role | What they receive |
|---|---|---|
| QVA149 | Experimental | QVA149 plus placebo once daily for 28 days. Receives: Drug: QVA149; Drug: Placebo |
| QAB149 + NVA237 | Active comparator | Indacaterol maleate (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days. Receives: Drug: NVA237; Drug: QAB149 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment
Spirometry was conducted according to internationally accepted standards. Trough FEV1 is defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings measured at day 29, after 28 days of treatment. Mixed model: Trough FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.
Measured: Day 29
Secondary outcomes (6)
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 1
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 1 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.
Measured: 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 1
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 28
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 28 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.
Measured: 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 28
Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 28 Post-dose
Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.
Measured: 5 min - 4 hr at Days 1 and 28
Time Course of Forced Expiratory Volume in One Second (FEV1) (Pre-dose to 4 Hours Post Dose) on Day 28
Time course of Forced Expiratory Volume in 1 second (FEV1) was measured at -45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Measured: -45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28
Change From Baseline in the Mean Daily, (Daytime and Nighttime Combined) Number of Puffs of Rescue Medication Used Over 28 Days of Treatment
The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening) then a half day was used in the denominator.
Measured: Baseline and 28 days
Change From Baseline in Percentage of Days With 'no Daytime Symptoms' Over 28 Days of Treatment
The mean total symptom scores and mean individual symptom scores for the patient were calculated for the whole study period. The mean change from baseline in the total scores and in the individual scores were summarized by treatment and were analyzed for the percentage of 'nights with no nighttime awakenings'. The symptom variables for the whole active treatment period was analyzed using the similar MIXED model as for the primary endpoint, with the baseline FEV1 term being replaced by the respective baseline symptom variables.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionDec 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529632
- Sponsor's protocol ID
- CQVA149A2326
- Other IDs
- 2011-006050-91
- Acronym
- BEACON
- Status last verified
- Jan 2014
- First submitted
- 6 Feb 2012
- Last updated
- 12 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare the Efficacy and Safety of Once Daily QVA149 Versus the Once Daily Concurrent Administration of QAB149 Plus NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01529632
- Acronym / sponsor ID
- BEACON / CQVA149A2326
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, COPD, QVA149, QAB149, NVA237, indacaterol, glycopyrronium bromide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Posted 12 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).
Detailed description
The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).
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: QVA149, Drug: PlaceboQVA149 plus placebo once daily for 28 days. |
| QAB149 + NVA237 | Active comparator | Drug: NVA237, Drug: QAB149Indacaterol maleate (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female adults aged ≥ 40 yrs
- Smoking history of at least 10 pack years
- Diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2010)
- Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Key exclusion criteria (9 listed)
- 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
- Patients with a history of certain cardiovascular co-morbid conditions
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 |
|---|---|---|
| QVA149QVA149 110/50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily | Drug | QVA149 |
| NVA237NVA237 50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily | Drug | QAB149 + NVA237 |
| QAB149QAB149 150 ug supplied as capsules in blister packs for inhalation via SDDPI , once daily | Drug | QAB149 + NVA237 |
| PlaceboPlacebo capsules provided in blister packs for inhalation via SDDPI, once daily | Drug | QVA149 |
Primary outcome
Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment
Time frame: Day 29
Spirometry was conducted according to internationally accepted standards. Trough FEV1 is defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings measured at day 29, after 28 days of treatment. Mixed model: Trough FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.
6 secondary outcomes
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 1
Time frame: 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 1
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 28
Time frame: 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 28
Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 28 Post-dose
Time frame: 5 min - 4 hr at Days 1 and 28
Time Course of Forced Expiratory Volume in One Second (FEV1) (Pre-dose to 4 Hours Post Dose) on Day 28
Time frame: -45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28
Change From Baseline in the Mean Daily, (Daytime and Nighttime Combined) Number of Puffs of Rescue Medication Used Over 28 Days of Treatment
Time frame: Baseline and 28 days
Change From Baseline in Percentage of Days With 'no Daytime Symptoms' Over 28 Days of Treatment
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
26 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QVA149, NVA237 and QAB149 in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 26 sites in 5 countries.
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 4 inclusion and 9 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 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Netherlands, Denmark, Norway, Austria, Sweden. 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 12 Feb 2014). 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?
Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2014.