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Chronic Obstructive Pulmonary DiseasePhase 3NCT01513460

Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

A Phase 3 study testing NVA237 50µg once daily, Tiotropium 18µg once daily and Flu/Sal in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 71 sites in 2 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

This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
NVA237 50µg once daily, Tiotropium 18µg once daily and Flu/Sal
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
773 participants
Where
71 sitesin 2 countries
Study dates
Apr 2012to Dec 2013
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 COPD (Stage II or Stage III) according to the GOLD 2010 guideline
  • Current or ex-smokers who have a smoking history of at least 10 pack years
  • Qualifying FEV1 at Visit 2 (day -7)

Who cannot join

  • Patients with a history of asthma or a history of high blood eosinophil count (>600/mm³)
  • Patients with concomitant pulmonary disease
  • Patients with lung lobectomy or lung volume reduction or lung transplantation
  • Patients with α-1 antitrypsin deficiency
  • Patients who have had live attenuated vaccinations within 30 days prior to screening visit or during run-in period
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

71 sites in 2 countries.

71 sites in 2 countries

Australia58 sites

  • Novartis Investigative Site

    Adelaide, South Australia, 5000

  • Novartis Investigative Site

    Arundel, Queensland, 4214

  • Novartis Investigative Site

    Aspley, Queensland, 4034

  • Novartis Investigative Site

    Baulkham Hills, New South Wales, 2153

  • Novartis Investigative Site

    Beenleigh, Queensland, 4207

  • Novartis Investigative Site

    Bicton, Western Australia

  • Novartis Investigative Site

    Brookvale, New South Wales, 2100

  • Novartis Investigative Site

    Browns Plains, Queensland, 4118

  • Novartis Investigative Site

    Castle Hill, New South Wales, 2067

  • Novartis Investigative Site

    Chemside, Queensland, 4032

  • Novartis Investigative Site

    Dandenong, Victoria

  • Novartis Investigative Site

    Dapto, New South Wales

  • Novartis Investigative Site

    Darlinghurst, New South Wales, 2010

  • Novartis Investigative Site

    Daw Park, South Australia, 5041

  • Novartis Investigative Site

    Deception Bay, Queensland, 4508

  • Novartis Investigative Site

    East Fremantle, Western Australia, 6158

  • Novartis Investigative Site

    East Victoria Park, Western Australia, 6101

  • Novartis Investigative Site

    Ermington, New South Wales

  • Novartis Investigative Site

    Everton Plaza, Queensland, 4053

  • Novartis Investigative Site

    Fremantle, Western Australia, 6160

  • Novartis Investigative Site

    Glenelg East, South Australia, 5045

  • Novartis Investigative Site

    Golden Grove, South Australia, 5125

  • Novartis Investigative Site

    Gosford, New South Wales, 2250

  • Novartis Investigative Site

    Hamley Bridge, South Australia, 5401

  • Novartis Investigative Site

    Hinchinbrook, New South Wales, 2168

  • Novartis Investigative Site

    Holland Park, Queensland, 4121

  • Novartis Investigative Site

    Jimboomba, Queensland, 4032

  • Novartis Investigative Site

    Kedron, Queensland

  • Novartis Investigative Site

    Kenmore, Queensland, 4069

  • Novartis Investigative Site

    Kensington Gardens, South Australia, 5065

  • Novartis Investigative Site

    Kingswood, New South Wales, 2747

  • Novartis Investigative Site

    Kippa-Ring, Queensland, 4021

  • Novartis Investigative Site

    Lalor, Victoria, 3075

  • Novartis Investigative Site

    Logan Central, Queensland, 4114

  • Novartis Investigative Site

    Loganholme, Queensland, 4129

  • Novartis Investigative Site

    Malvern, Victoria, 3144

  • Novartis Investigative Site

    Melbourne, Victoria

  • Novartis Investigative Site

    Mermaid Beach, Queensland, 4218

  • Novartis Investigative Site

    Mirrabooka, Western Australia, 6061

  • Novartis Investigative Site

    Morayfield, Queensland, 4506

  • Novartis Investigative Site

    Morley, Western Australia, 6062

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009

  • Novartis Investigative Site

    Nerang, Queensland, 4211

  • Novartis Investigative Site

    Noble Park, Victoria, 3174

  • Novartis Investigative Site

    Noranda, Western Australia

  • Novartis Investigative Site

    Oakleigh East, Victoria, 3166

  • Novartis Investigative Site

    Perth, Western Australia, 6000

  • Novartis Investigative Site

    Perth, Western Australia, 6069

  • Novartis Investigative Site

    Perth, Western Australia

  • Novartis Investigative Site

    Pinjarra, Western Australia

  • Novartis Investigative Site

    Preston, Victoria

  • Novartis Investigative Site

    Prospect, South Australia, 5082

  • Novartis Investigative Site

    Rosebud, Victoria, 3063

  • Novartis Investigative Site

    Spearwood, Western Australia, 6163

  • Novartis Investigative Site

    Sydney, New South Wales, 2089

  • Novartis Investigative Site

    Woodvale, Western Australia, 6026

  • Novartis Investigative Site

    Woolloongabba, Queensland, 4102

  • Novartis Investigative Site

    Yokine, Western Australia, 6060

Other trials in Australia

New Zealand13 sites

  • Novartis Investigative Site

    Auckland, New Zealand, 1051

  • Novartis Investigative Site

    Auckland, New Zealand

  • Novartis Investigative Site

    Auckland

  • Novartis Investigative Site

    Christchurch, New Zealand

  • Novartis Investigative Site

    Christchurch

  • Novartis Investigative Site

    Dunedin

  • Novartis Investigative Site

    Grafton, Auckland, 1010

  • Novartis Investigative Site

    Hamilton, New Zealand, 3240

  • Novartis Investigative Site

    Tauranga, New Zealand, 3143

  • Novartis Investigative Site

    Tauranga, New Zealand

  • Novartis Investigative Site

    Tauranga, Tauranga

  • Novartis Investigative Site

    Wellington, Wellington Region

  • Novartis Investigative Site

    Wellington, 6021

Other trials in New Zealand

About this study

Official title: A Multicenter, Randomized, Blinded, Active-controlled, Parallel-group Study to Compare the Efficacy, Tolerability and Safety of NVA237 Compared to Tiotropium Added on to Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease

This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease.

Being tested
NVA237 50µg once daily, Tiotropium 18µg once daily, Flu/Sal, NVA237 placebo + Tiotropium placebo.
Keywords
Chronic Obstructive Pulmonary Disease,, NVA 237,, glycopyrronium,, COPD
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.

  • NVA237 50µg once dailyDrug

    NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI)

  • Tiotropium 18µg once dailyDrug

    Tiotropium 18 μg o.d. delivered via a proprietary inhalation device

  • Flu/SalDrug

    Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device

  • NVA237 placebo + Tiotropium placebo.Drug

    Tiotropium 18 μg o.d. delivered via a proprietary inhalation device

Study groups in NCT01513460
Study groupRoleWhat they receive
NVA237 + Fluticasone/Salmeterol (Flu/Sal)ExperimentalNVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
Receives: Drug: NVA237 50µg once daily; Drug: Flu/Sal; Drug: NVA237 placebo + Tiotropium placebo.
Tiotropium + Flu/SalActive comparatorTiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
Receives: Drug: Tiotropium 18µg once daily; Drug: Flu/Sal; Drug: NVA237 placebo + Tiotropium placebo.
Flu/SalPlacebo comparatorPlacebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
Receives: Drug: Flu/Sal; Drug: NVA237 placebo + Tiotropium placebo.

What is being measured

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

  1. Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium)

    Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15 hours and 23:45 hours after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45 min and 15 min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.

    Measured: baseline, 12 weeks

Secondary outcomes (6)

  1. Change From Baseline in Mean Trough FEV1 (Flu/Sal Versus NVA237/Tiotropium+Flu/Sal)

    Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.

    Measured: baseline, 4 weeks, 8 weeks, 12 weeks

  2. Change From Baseline in Mean Trough FEV1

    Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.

    Measured: baseline, 4 weeks, 8 weeks, 12 weeks

  3. Change From Baseline in Total Score of the St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) After 12 Weeks of Treatment

    SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity\& impacts. The lowest possible value is zero and the highest is 100. Higher values corresponded to greater impairment in quality of life. An analysis model included terms for treatment, baseline total SGRQ score, FEV1 and baseline smoking status. The model also contained as fixed effects the baseline total SGRQ score, FEV1 prior to inhalation of short acting bronchodilator, FEV1 post inhalation of short acting bronchodilator and stratification factors as covariates. A negative change from baseline indicates improvement.

    Measured: 12 weeks

  4. Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Use

    The total number of puffs of rescue medication used over the last 12 h recorded in the morning (nighttime use) and in the evening (daytime use) over the full 12 weeks was divided by the total number of days with non-missing rescue data to derive the mean daytime and nighttime number of puffs of rescue medication. Change from baseline in the mean daytime and nighttime number of puffs of rescue medication was analyzed as for the change from baseline in the mean daily number of puffs of rescue medication.

    Measured: baseline, 12 weeks

  5. Mean Percentage of Nights With 'no Nighttime Awakenings'

    A night with 'no nighttime awakenings' is defined from diary data as any night where patient did not wake up due to symptoms. Total number of nights with 'no nighttime awakenings' over treatment period was divided by total number of nights where diary recordings have been made in order to derive percentage of 'no nighttime awakenings' which will be summarized by treatment and analyzed using a similar mixed model as specified for primary analysis. Diary data recorded during the 7 day run-in period was used to calculate baseline percentage of nights 'no nighttime awakenings'.

    Measured: 12 weeks

  6. Mean Percentage of Days With Performance of Usual Activities

    A 'day able to perform usual daily activities' was defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The percentage of 'days able to perform usual daily activities' was derived and analyzed using a similar mixed model as specified for primary analysis as for the percentage of nights with 'no nighttime awakenings'.

    Measured: 12 weeks

Timeline

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

  1. First posted20 Jan 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
773 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01513460
Sponsor's protocol ID
CNVA237AAU01
Status last verified
Dec 2014
First submitted
16 Jan 2012
Last updated
5 Jan 2015

Publications

  • Frith PA, Thompson PJ, Ratnavadivel R, Chang CL, Bremner P, Day P, Frenzel C, Kurstjens N; Glisten Study Group. Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial. Thorax. 2015 Jun;70(6):519-27. doi: 10.1136/thoraxjnl-2014-206670. Epub 2015 Apr 3.

    PubMed 25841237

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NVA237 50µg once daily, Tiotropium 18µg once daily and Flu/Sal in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 71 sites in 2 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 3 inclusion and 6 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 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in Australia, New Zealand. 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 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 5 Jan 2015). 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 Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium) (time frame: baseline, 12 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 NCT01513460, which also lists 1 linked publication.

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 5 Jan 2015.

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