- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01529632
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)
January 16, 2014 updated by: Novartis Pharmaceuticals
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
193
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Feldbach, Austria, 8330
- Novartis Investigative Site
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Grieskirchen, Austria, 4710
- Novartis Investigative Site
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Linz, Austria, 4020
- Novartis Investigative Site
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Wels, Austria, 4600
- Novartis Investigative Site
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Aalborg, Denmark, DK-9100
- Novartis Investigative Site
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Copenhagen NV, Denmark, DK-2400
- Novartis Investigative Site
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Hvidovre, Denmark, DK-2650
- Novartis Investigative Site
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Odense C, Denmark, DK-5000
- Novartis Investigative Site
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Århus, Denmark, DK-8000
- Novartis Investigative Site
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Almelo, Netherlands, 7609 PP
- Novartis Investigative Site
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Eindhoven, Netherlands, 5623 EJ
- Novartis Investigative Site
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Harderwijk, Netherlands, 3840 AC
- Novartis Investigative Site
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Heerlen, Netherlands, 6419 PC
- Novartis Investigative Site
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Hengelo, Netherlands, 7555 DL
- Novartis Investigative Site
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Sittard-Geleen, Netherlands, 6162 BG
- Novartis Investigative Site
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Tubbergen, Netherlands, 7651 JH
- Novartis Investigative Site
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Veldhoven, Netherlands, 5504 DB
- Novartis Investigative Site
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Kløfta, Norway, 2040
- Novartis Investigative Site
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Kongsvinger, Norway, 2212
- Novartis Investigative Site
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Skedsmokorset, Norway, 2020
- Novartis Investigative Site
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Stavanger, Norway, 4005
- Novartis Investigative Site
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Trondheim, Norway, 7006
- Novartis Investigative Site
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Göteborg, Sweden, 412 63
- Novartis Investigative Site
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Stockholm, Sweden, 111 57
- Novartis Investigative Site
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Stockholm, Sweden, S-171 76
- Novartis Investigative Site
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Uddevalla, Sweden, 451 50
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: QVA149
QVA149 plus placebo once daily for 28 days.
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QVA149 110/50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily
Placebo capsules provided in blister packs for inhalation via SDDPI, once daily
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Active Comparator: QAB149 + NVA237
Indacaterol maleate (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
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NVA237 50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily
QAB149 150 ug supplied as capsules in blister packs for inhalation via SDDPI , once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment
Time Frame: Day 29
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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.
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Day 29
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 1
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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
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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.
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0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 28
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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
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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.
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5 min - 4 hr at Days 1 and 28
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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
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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.
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-45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28
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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
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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.
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Baseline and 28 days
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Change From Baseline in Percentage of Days With 'no Daytime Symptoms' Over 28 Days of Treatment
Time Frame: 28 days
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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.
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
February 6, 2012
First Submitted That Met QC Criteria
February 8, 2012
First Posted (Estimate)
February 9, 2012
Study Record Updates
Last Update Posted (Estimate)
February 12, 2014
Last Update Submitted That Met QC Criteria
January 16, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Adjuvants, Anesthesia
- Glycopyrrolate
Other Study ID Numbers
- CQVA149A2326
- 2011-006050-91 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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