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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) (BEACON)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
QVA149
NVA237
QAB149
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic obstructive pulmonary disease, COPD, QVA149, QAB149, NVA237, indacaterol, glycopyrronium bromide

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QVA149

QAB149 + NVA237

Arm Description

QVA149 plus placebo once daily for 28 days.

Indacaterol maleate (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 6, 2012
Last Updated
January 16, 2014
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01529632
Brief Title
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)
Acronym
BEACON
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
chronic obstructive pulmonary disease, COPD, QVA149, QAB149, NVA237, indacaterol, glycopyrronium bromide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QVA149
Arm Type
Experimental
Arm Description
QVA149 plus placebo once daily for 28 days.
Arm Title
QAB149 + NVA237
Arm Type
Active Comparator
Arm Description
Indacaterol maleate (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
Intervention Type
Drug
Intervention Name(s)
QVA149
Intervention Description
QVA149 110/50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily
Intervention Type
Drug
Intervention Name(s)
NVA237
Intervention Description
NVA237 50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily
Intervention Type
Drug
Intervention Name(s)
QAB149
Intervention Description
QAB149 150 ug supplied as capsules in blister packs for inhalation via SDDPI , once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules provided in blister packs for inhalation via SDDPI, once daily
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment
Description
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.
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 1
Description
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.
Time Frame
0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 1
Title
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 28
Description
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.
Time Frame
0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 28
Title
Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 28 Post-dose
Description
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.
Time Frame
5 min - 4 hr at Days 1 and 28
Title
Time Course of Forced Expiratory Volume in One Second (FEV1) (Pre-dose to 4 Hours Post Dose) on Day 28
Description
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.
Time Frame
-45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28
Title
Change From Baseline in the Mean Daily, (Daytime and Nighttime Combined) Number of Puffs of Rescue Medication Used Over 28 Days of Treatment
Description
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.
Time Frame
Baseline and 28 days
Title
Change From Baseline in Percentage of Days With 'no Daytime Symptoms' Over 28 Days of Treatment
Description
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.
Time Frame
28 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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% Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Feldbach
ZIP/Postal Code
8330
Country
Austria
Facility Name
Novartis Investigative Site
City
Grieskirchen
ZIP/Postal Code
4710
Country
Austria
Facility Name
Novartis Investigative Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Novartis Investigative Site
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Novartis Investigative Site
City
Aalborg
ZIP/Postal Code
DK-9100
Country
Denmark
Facility Name
Novartis Investigative Site
City
Copenhagen NV
ZIP/Postal Code
DK-2400
Country
Denmark
Facility Name
Novartis Investigative Site
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
Facility Name
Novartis Investigative Site
City
Odense C
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Århus
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Harderwijk
ZIP/Postal Code
3840 AC
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Hengelo
ZIP/Postal Code
7555 DL
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Tubbergen
ZIP/Postal Code
7651 JH
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Kløfta
ZIP/Postal Code
2040
Country
Norway
Facility Name
Novartis Investigative Site
City
Kongsvinger
ZIP/Postal Code
2212
Country
Norway
Facility Name
Novartis Investigative Site
City
Skedsmokorset
ZIP/Postal Code
2020
Country
Norway
Facility Name
Novartis Investigative Site
City
Stavanger
ZIP/Postal Code
4005
Country
Norway
Facility Name
Novartis Investigative Site
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Novartis Investigative Site
City
Göteborg
ZIP/Postal Code
412 63
Country
Sweden
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
111 57
Country
Sweden
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
S-171 76
Country
Sweden
Facility Name
Novartis Investigative Site
City
Uddevalla
ZIP/Postal Code
451 50
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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)

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