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Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT00558285

Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing indacaterol/glycopyrrolate, indacaterol and glycopyrrolate in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis at 40 sites in 8 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

An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
indacaterol/glycopyrrolate, indacaterol and glycopyrrolate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
257 participants
Where
40 sitesin 8 countries
Study dates
Nov 2007to Jul 2008
Phase
Phase 2
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

  • Consented male or female adults aged ≥40 years
  • Moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2006)
  • Patients who have smoking history of at least 10 pack years
  • Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥30% and <80% of the predicted normal and post-bronchodilator FEV1/Forced vital capacity (FVC) <0.70 at Visit 1 and Visit 3

Who cannot join

  • Pregnant or nursing (lactating) women
  • Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency room for a COPD exacerbation in the 6 weeks prior to screening (Visit 1) or during the screening period
  • Patients who had a respiratory tract infection within 6 weeks of Visit 1 or at screening
  • Concomitant pulmonary disease, pulmonary tuberculosis (TB) (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis
  • Any history of asthma
  • Patients who have clinically relevant lab abnormalities / conditions such as (but not limited to) long term prednisone therapy, unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding stable atrial fibrillation [AF]), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
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  • Patients with a history of cardiac failure, life threatening arrhythmias (screening Holter) and acute ischemic changes (screening ECG)
  • Patients with a history of long QT syndrome or whose QTc (Fridericia method) interval measured at screening (Visit 1) is prolonged (>450 ms for males or >470 for females)
  • History of malignancy of any organ system, treated or untreated within the past 5 years
  • Uncontrolled Type I / Type II Diabetes or blood glucose outside the normal range or Hemoglobin A1C (HbA1c) >8.0% of total hemoglobin measured at Visit 1
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

40 sites in 8 countries.

40 sites in 8 countries

France7 sites

  • Novartis Investigator Site

    Ambroise

  • Novartis Investigator Site

    Lille

  • Novartis Investigator Site

    Marseille

  • Novartis investigator site

    Martigues

  • Novartis Investigator Site

    Nantes

  • Novartis Investigator site

    Nice

  • Novartis Investigator Site

    Perpignan

Other trials in France

Canada6 sites

  • Novartis Investigator Site

    Mississauga

  • Novartis Investigator Site

    Newmarket

  • Novartis Investigator Site

    Ottawa

  • Novartis Investigator Site

    Pointe-Claire

  • Novartis Investigator Site

    Québec

  • Novartis Investigator Site

    Sainte-Foy

Other trials in Canada

Germany6 sites

  • Novartis Investigator Site

    Berlin

  • Novartis Investigator Site

    Dortmund

  • Novartis Investigator Site

    Erfurt

  • Novartis Investigator Site

    Hanover

  • Novartis Investigator Site

    Mainz

  • Novartis Investigator Site

    Marburg

Other trials in Germany

Spain6 sites

  • Novartis Investigator Site

    Badalona

  • Novartis Investigator Site

    Barakaldo

  • Novartis Investigator Site

    Cáceres

  • Novartis Investigator Site

    Centelles

  • Novartis Investigator Site

    Mataró

  • Novartis Investigator Site

    Valencia

Other trials in Spain

Australia5 sites

  • Novartis Investigator Site

    Adelaide

  • Novartis Investigator Site

    Clayton

  • Novartis Investigator Site

    Daw Park

  • Novartis Investigator site

    Heidelberg

  • Novartis Investigator Site

    Nedlands

Other trials in Australia

Belgium5 sites

  • Novartis Investigator Site

    Brussels

  • Novartis Investigator Site

    Jambes

  • Novartis Investigator Site

    Jette

  • Novartis Investigator site

    Liège

  • Novartis Investigator Site

    Ostend

Other trials in Belgium

Italy3 sites

  • Novartis Investigator Site

    Florence

  • Novartis Investigator site

    Modena

  • Novartis Investigator Site

    Trieste

Other trials in Italy

Turkey (Türkiye)2 sites

  • Novartis Investigator Site

    Istanbul

  • Novartis Investigator Site

    Izmir

Other trials in Turkey (Türkiye)

About this study

Official title: A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Determine the Effect of QVA149 on Mean 24-hours Heart Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.

Being tested
indacaterol/glycopyrrolate, indacaterol, glycopyrrolate, placebo
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, QVA149
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/glycopyrrolateDrug

    Also called QVA149

    Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

  • indacaterolDrug

    Also called QAB149

    Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

  • glycopyrrolateDrug

    Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

  • placeboDrug

    Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

Study groups in NCT00558285
Study groupRoleWhat they receive
indacaterol/glycopyrrolate 600/100 μgExperimentalTwo capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
Receives: Drug: indacaterol/glycopyrrolate
indacaterol/glycopyrrolate 300/100 μgExperimentalOne capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
Receives: Drug: indacaterol/glycopyrrolate; Drug: placebo
indacaterol/glycopyrrolate 150/100 μgExperimentalOne capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
Receives: Drug: indacaterol/glycopyrrolate; Drug: glycopyrrolate
indacaterol 300 μgActive comparatorOne capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
Receives: Drug: indacaterol; Drug: placebo
placeboPlacebo comparatorTwo placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
Receives: Drug: placebo

What is being measured

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

  1. Change From Baseline in Mean 24 Hour Heart Rate at Day 14

    Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 14. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least square means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min post salbutamol/albuterol + error.

    Measured: Baseline, Day 14

Secondary outcomes (6)

  1. Change From Baseline in Mean 24 Hour Heart Rate at Day 1

    Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 1. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least squares means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.

    Measured: Baseline, Day 1

  2. Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14

    Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline is defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Least square means are based on the analysis of covariance: response variable=center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.

    Measured: Day 1, Day 14

  3. Trough Forced Vital Capacity (FVC) at Day 1 and Day 14

    Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FVC was defined as the mean of two measurements at 23 hours 15 minutes and the 23 hours 45 minutes post dosing. Baseline was defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Analysis of covariance: FVC parameter = center + treatment + baseline FVC + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.

    Measured: Day 1 and Day 14

  4. Change From Baseline in QTc (Fridericia's Formula) at Day 1

    The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 1. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.

    Measured: Baseline, Day 1

  5. Change From Baseline in QTc (Fridericia's Formula) at Day 7

    The change from baseline in QTc at 30 minutes and 2 hours post dose on day 7. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.

    Measured: Baseline, Day 7

  6. Change From Baseline in QTc (Fridericia's Formula) at Day 14

    The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 14. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.

    Measured: Baseline, Day 14

Timeline

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

  1. First posted14 Nov 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00558285
Sponsor's protocol ID
CQVA149A2203
Status last verified
Nov 2012
First submitted
12 Nov 2007
Last updated
30 Nov 2012

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing indacaterol/glycopyrrolate, indacaterol and glycopyrrolate in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis at 40 sites in 8 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 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 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in France, Canada, Germany, Spain, Australia and 3 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 22 Nov 2012). 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?

Change From Baseline in Mean 24 Hour Heart Rate at Day 14 (time frame: Baseline, Day 14). 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 NCT00558285.

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 30 Nov 2012.

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