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Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT01285492

Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing QVA149 and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 35 sites in Japan.

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

This is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237 ([glycopyrronium bromide]) using tiotropium as an active control in Japanese patients with moderate to severe chronic obstructive… Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
QVA149 and Tiotropium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
35 sitesJapan
Study dates
Jan 2011to Sep 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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
  • Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
  • Patients with post-bronchodilator forced expiratory volume in one second (FEV1) ≥30% and < 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) < 0.7 at Visit 2.

Who cannot join

  • Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception
  • Patients requiring long term oxygen therapy
  • Patients who have had a lower respiratory tract infection within 4 weeks prior to Visit 1
  • Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Any patient with history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years
Show all 11Show fewer
  • Patients with a history of certain cardiovascular comorbid 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 treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

Japan35 sites

  • Novartis Investigative Site

    Akita, Akita, 010-0933

  • Novartis Investigative Site

    Anjo, Aichi-ken, 446-8602

  • Novartis Investigative Site

    Asahikawa, Hokkaido, 070-8644

  • Novartis Investigative Site

    Fuchū, Tokyo, 183-8524

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 811-0213

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-0033

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 815-8588

  • Novartis Investigative Site

    Hamamatsu, Shizuoka, 430-8525

  • Novartis Investigative Site

    Himeji, Hyōgo, 672-8064

  • Novartis Investigative Site

    Kanazawa, Ishikawa-ken, 920-8610

  • Novartis Investigative Site

    Kasuga, Fukuoka, 816-0813

  • Novartis Investigative Site

    Kawaguhi-city, Saitama, 333-0833

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 210-0852

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 820-0052

  • Novartis Investigative Site

    Kochi, Kochi, 780-8077

  • Novartis Investigative Site

    Kōshi, Kumamoto, 861-1196

  • Novartis Investigative Site

    Kurume, Fukuoka, 830-0011

  • Novartis Investigative Site

    Matsusaka, Mie-ken, 515-8544

  • Novartis Investigative Site

    Meguro City, Tokyo, 152-8902

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 457-8511

  • Novartis Investigative Site

    Nishio, Aichi-ken, 445-8510

  • Novartis Investigative Site

    Obihiro, Hokkaido, 080-0805

  • Novartis Investigative Site

    Osaka, Osaka, 545-8586

  • Novartis Investigative Site

    Osaka, Osaka, 558-8558

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648

  • Novartis Investigative Site

    Sayama, Osaka, 589-0022

  • Novartis Investigative Site

    Takamatsu, Kagawa-ken, 760-8538

  • Novartis Investigative Site

    Takatsuki, Osaka, 569-1192

  • Novartis Investigative Site

    Toyonaka, Osaka, 560-8552

  • Novartis Investigative Site

    Ube, Yamaguchi, 755-0241

  • Novartis Investigative Site

    Ueda, Nagano, 386-8610

  • Novartis Investigative Site

    Wakayama, Wakayama, 641-8510

  • Novartis Investigative Site

    Yamagata, Yamagata, 990-8533

  • Novartis Investigative Site

    Yanagawa, Fukuoka, 832-0059

  • Novartis Investigative Site

    Yokohama, Kanagawa, 236-0051

Other trials in Japan

About this study

Official title: A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Tolerability of QVA149 (110 Mcg Indacaterol / 50 Mcg Glycopyrrolate o.d.) Using Tiotropium (18 Mcg o.d.) as an Active Control in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237 ([glycopyrronium bromide]) using tiotropium as an active control in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Being tested
QVA149, Tiotropium
Keywords
COPD, QVA149, NVA237, indacaterol, combination bronchodilator
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 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1

  • TiotropiumDrug

    Tiotropium (18 μg o.d.), delivered via Handihaler®

Study groups in NCT01285492
Study groupRoleWhat they receive
QVA149ExperimentalQVA149 110/50 μg once a day (o.d)
Receives: Drug: QVA149
TiotropiumActive comparatortiotropium 18 μg o.d.
Receives: Drug: Tiotropium

What is being measured

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

  1. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death

    An AE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that was given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug were classified as a treatment emergent adverse event.

    Measured: 52 weeks

Secondary outcomes (6)

  1. Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period

    Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL

    Measured: 52 weeks

  2. Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period

    Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL

    Measured: 52 weeks

  3. Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period

    Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.

    Measured: 52 weeks

  4. Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period

    Clinically notable change from baseline was an increase from baseline of 30 or greater milliseconds (ms).

    Measured: 52 weeks

  5. Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline

    Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FEV1 value on Day 1 (Week 1).

    Measured: Weeks 3, 6, 12, 24, 36, 52

  6. Change in Pre-dose Forced Vital Capacity (FVC) From Baseline

    Pre-dose FVC is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FVC value on Day 1 (Week 1).

    Measured: Weeks 3, 6, 12, 24, 36, 52

Timeline

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

  1. First posted28 Jan 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionSep 2012
  4. Study completionSep 2012

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01285492
Sponsor's protocol ID
CQVA149A1301
Status last verified
Dec 2013
First submitted
25 Jan 2011
Last updated
27 Dec 2013

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QVA149 and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 35 sites in Japan.

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 3 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 27 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Japan. 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 7 Nov 2013). 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?

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death (time frame: 52 weeks). 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 NCT01285492.

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 27 Dec 2013.

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