Pulmonary Disease, Chronic ObstructivePhase 3NCT01837927
Efficacy of NVA237 (50 μg o.d) Using Tiotropium (5μg μg o.d) as Active Control in COPD Patients.
A Phase 3 study testing NVA237 and Tiotropium Respimat® in people with Pulmonary Disease, Chronic Obstructive, run by Novartis Pharmaceuticals.
Trial summary
This study will assess the Efficacy of NVA237 (50 μg o.d) using tiotropium (5μg μg o.d) as active control in COPD patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- NVA237 and Tiotropium Respimat®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Apr 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Men and women aged 40 years or over.
- History of current or former smoking of at least 10 pack-years
- Cooperative outpatients, with a COPD diagnosis established by the measurement of FEV1/FVC < 0.7 post-bronchodilation in basal spirometry (without use of medication or post-washout). Moderate to severe stage patients will be included, with post-bronchodilator FEV1 between 30 and 80% of the normal value according to GOLD 2011 since the inclusion criteria in this trial will be based on spirometry results.
Who cannot join
- Pregnant women or nursing mothers
- History of asthma at visit 1 indicated by, but not limited to:
- Onset of respiratory symptoms suggestive of asthma (such as coughing, wheezing, shortness of breath) before the age of 40.
- History of diagnosed asthma
- History of respiratory tract infection within six weeks prior to Visit 1.
- History of hospitalization or emergency care for a COPD exacerbation in the 3 months prior to Visit 1.
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- Subjects who require use of home oxygen therapy.
- Patients in the active phase of an assisted pulmonary rehabilitation program and patients who completed the rehabilitation program within 18 months from Visit 1 or 2 of the protocol.17,20
- Patients with known history and diagnosis of alpha-1 antitrypsin deficiency.
- Patients with concomitant lung disease, e.g.: tuberculosis (unless confirmed by radiography as inactive) or clinically significant bronchiectasis.
- Patients who in the investigator's judgment have an abnormality or significant medical condition such as: unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (except chronic stable atrial fibrillation), history of malignancy of any system (including lung cancer) treated or not within the last 5 years, glaucoma, prostatic hyperplasia, moderate to severe renal impairment, urinary retention, any other condition that might compromise patient safety or compliance, interfere with the evaluations, or prevent the termination of their participation in the study.
- Patients with contraindications to tiotropium or ipratropium treatment or who have experienced undesirable reactions with inhaled anticholinergic agents or patients with a history of an undesirable reaction with sympathomimetic amines or inhaled medication with any of those components, or a history of hypersensitivity to any of the study medications, including rescue medication, or similar classes of medication.
- Patients using tiotropium, long-acting anticholinergics, short-acting anticholinergics, fixed combinations of inhaled beta agonists and inhaled corticosteroids, theophylline. In these cases, the patient is allowed, after agreeing to participate in the study, to enter a washout period from Visit
- Patients using inhaled steroids, alone or as an exchange in a fixed combination at equivalent doses, unless on a stable treatment for at least 1 month prior to randomization
- Patients using nonselective beta-blockers.
- Patients using cromoglycate, nedocromil, ketotifen and leukotriene antagonists unless on stable treatment for at least 1 month prior to randomization .
- Patients who used oral prednisone (or equivalent) over a long period, defined as ≥ 10 mg/day for at least 1 month prior to Visit 1
- Patients who used intramuscular depot corticosteroids within 30 days from Visit 1.
- Patients with a history of long QT Syndrome or with prolonged QTc (> 450 ms) measured at Visit 1 (Fridericia Method).
- Patients who, in the opinion of the investigator, have clinically significant abnormalities on ECG. These patients should not be re-screened.
- Other exclusion criteria may apply
About this study
Official title: A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Efficacy of NVA237 (50 μg o.d.) Using Tiotropium (5 μg o.d.) as an Active Control in Brazilian Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.
This study will assess the Efficacy of NVA237 (50 μg o.d) using tiotropium (5μg μg o.d) as active control in COPD patients.
Read the detailed description
A 52-week treatment, multicenter, randomized, open-label, parallel-group study to assess the efficacy of NVA237 (50μg once daily) using Tiotropium (5μg once daily) as an active control in Brazilian patients with moderate to severe Chronic Obstructive Pulmonary Disease.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- NVA237, Tiotropium Respimat®
- Keywords
- Efficacy, NVA237, Tiotropium, Chronic Obstructive Pulmonary Disease, 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.
NVA237Drug
Once daily for 52 weeks
Tiotropium Respimat®Drug
Once daily for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| NVA237 | Experimental | NVA237 inhaled via the Breezhaler® device once daily Receives: Drug: NVA237 |
| Tiotropium | Active comparator | Tiotropium 5μg inhaled via the Respimat® device once daily Receives: Drug: Tiotropium Respimat® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Measured: Baseline and 12 weeks after treatment.
Secondary outcomes (6)
Forced Expiratory Volume in 1 Second (FEV1) at day 1
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Measured: 30 and 60 minutes post-dose on the first day of study treatment.
Forced Expiratory Volume in 1 Second (FEV1) at day 7 and weeks 12, 24 and 52
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Measured: 30 and 60 minutes post-dose on the 7th day of study treatment and at weeks 12, 24 and 52
Forced Expiratory Volume in 1 Second (FEV1) at weeks 24 and 52
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Measured: pre-dose at weeks 24 and 52 of study treatment
Change From Baseline in Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Measured: Days 1 and 7, weeks 12, 24 and 52 of study treatment
FEV1 AUC 0-4h
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Measured: 05, 30, 60 minutes and 4 hours post-dose at days 1, 7 and week 12
Safety and tolerance of NVA237
All AEs and SAEs will be reported
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startApr 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837927
- Sponsor's protocol ID
- CNVA237ABR01
- Status last verified
- Aug 2016
- First submitted
- 18 Apr 2013
- Last updated
- 22 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Efficacy of NVA237 (50 μg o.d.) Using Tiotropium (5 μg o.d.) as an Active Control in Brazilian Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT01837927
- Acronym / sponsor ID
- CNVA237ABR01
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Efficacy, NVA237, Tiotropium, Chronic Obstructive Pulmonary Disease, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the Efficacy of NVA237 (50 μg o.d) using tiotropium (5μg μg o.d) as active control in COPD patients.
Detailed description
A 52-week treatment, multicenter, randomized, open-label, parallel-group study to assess the efficacy of NVA237 (50μg once daily) using Tiotropium (5μg once daily) as an active control in Brazilian patients with moderate to severe Chronic Obstructive Pulmonary Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVA237 | Experimental | Drug: NVA237NVA237 inhaled via the Breezhaler® device once daily |
| Tiotropium | Active comparator | Drug: Tiotropium Respimat®Tiotropium 5μg inhaled via the Respimat® device once daily |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged 40 years or over.
- History of current or former smoking of at least 10 pack-years
- Cooperative outpatients, with a COPD diagnosis established by the measurement of FEV1/FVC < 0.7 post-bronchodilation in basal spirometry (without use of medication or post-washout). Moderate to severe stage patients will be included, with post-bronchodilator FEV1 between 30 and 80% of the normal value according to GOLD 2011 since the inclusion criteria in this trial will be based on spirometry results.
Key exclusion criteria (21 listed)
- Pregnant women or nursing mothers
- History of asthma at visit 1 indicated by, but not limited to:
- History of respiratory tract infection within six weeks prior to Visit 1.
- History of hospitalization or emergency care for a COPD exacerbation in the 3 months prior to Visit 1.
- Subjects who require use of home oxygen therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVA237Once daily for 52 weeks | Drug | NVA237 |
| Tiotropium Respimat®Once daily for 52 weeks | Drug | Tiotropium |
Primary outcome
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline and 12 weeks after treatment.
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
6 secondary outcomes
Forced Expiratory Volume in 1 Second (FEV1) at day 1
Time frame: 30 and 60 minutes post-dose on the first day of study treatment.
Forced Expiratory Volume in 1 Second (FEV1) at day 7 and weeks 12, 24 and 52
Time frame: 30 and 60 minutes post-dose on the 7th day of study treatment and at weeks 12, 24 and 52
Forced Expiratory Volume in 1 Second (FEV1) at weeks 24 and 52
Time frame: pre-dose at weeks 24 and 52 of study treatment
Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Days 1 and 7, weeks 12, 24 and 52 of study treatment
FEV1 AUC 0-4h
Time frame: 05, 30, 60 minutes and 4 hours post-dose at days 1, 7 and week 12
Safety and tolerance of NVA237
Time frame: 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NVA237 and Tiotropium Respimat® in people with Pulmonary Disease, Chronic Obstructive, run by Novartis Pharmaceuticals.
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 21 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: withdrawn, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 Forced Expiratory Volume in 1 Second (FEV1) (time frame: Baseline and 12 weeks after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.