Chronic Obstructive Pulmonary DiseasePhase 3GLOW8NCT01757015
Safety and Efficacy of NVA237 as an add-on to Fixed Dose Combination LABA/ICS
A Phase 3 study testing NVA237 in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals.
Trial summary
This study is to evaluate if add-on treatment with inhaled NVA237 (50 µg) once daily (o.d.) via single-dose dry-powder inhaler (SDDPI) further improves lung function and health status and is well tolerated compared to placebo in symptomatic COPD patients with moderate to severe airflow limitation who are already… 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Apr 2014
- 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
- Current or ex-smokers who have a smoking history of at least 10 pack years (e.g., 10 pack years = 1 pack/day × 10 years, ½ pack/day × 20 years, etc.).
- COPD (Chronic Obstructive Pulmonary Disease) patients with moderate to severe airflow limitation (Spirometry classification: GOLD 2 or 3) at Visit 2:
- Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) ≥30% and <60% of the predicted normal, and,
- Post-bronchodilator FEV1/forced vital capacity (FVC) <0.70
- Patients on maintenance treatment with fixed-dose combination of inhaled salmeterol and fluticasone propionate (50/500 µg) b.i.d. delivered via a proprietary MDDPI (multidose dry powder inhaler) device for at least 30 days prior to screening visit (Visit 1).
- Patients in category Gold B or D with a CAT (COPD Assessment Test) total score ≥10 at screening (Visit 1) and before randomization (Visit 3).
- Patients with a history of at least 1 moderate or severe COPD exacerbation within the previous year.
Who cannot join
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unless they are using effective methods of contraception during the study
- Patients with a history of long QT syndrome or whose QTc measured at run-in (Visit 2) (Fridericia method) is prolonged (>450 ms). (These patients cannot be re-screened.)
- Patients with evidence (upon visual inspection) of oropharyngeal candidiasis at baseline with or without treatment.
- Patients who have not achieved an acceptable spirometry result at run-in (Visit 2) in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability and repeatability.
- Patients who have had a COPD exacerbation that required treatment with antibiotics or oral corticosteroids or hospitalization in the 6 weeks prior to screening (Visit 1).
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- Patients who have had a respiratory tract infection within 4 weeks prior to screening (Visit 1).
- Patients requiring long term oxygen therapy prescribed for >12 hours per day.
- Patients with allergic rhinitis who use an H1 antagonist or intra-nasal corticosteroids intermittently. (Treatment with a stable dose or regimen is permitted.)
- Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, or pulmonary hypertension), clinically significant bronchiectasis, or history of pulmonary lobectomy, lung volume reduction surgery, or lung transplantation.
- Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active.
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
Official title: A 26-week Multi-center Randomized Double-blind Study to Compare Efficacy and Safety of NVA237 Versus Placebo as an add-on to Maintenance Therapy With Fixed-dose Combination Salmeterol/Fluticasone Propionate in COPD Patients With Moderate to Severe Airflow Limitation
This study is to evaluate if add-on treatment with inhaled NVA237 (50 µg) once daily (o.d.) via single-dose dry-powder inhaler (SDDPI) further improves lung function and health status and is well tolerated compared to placebo in symptomatic COPD patients with moderate to severe airflow limitation who are already receiving maintenance therapy with inhaled fixed-dose-combination of salmeterol/fluticasone propionate (50/500 µg) twice daily (b.i.d.) via multi-dose dry powder inhaler (MDDPI).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- NVA237, Placebo to NVA237
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Moderate to severe airflow limitation, GOLD spirometric classification 2 and 3, GOLD group B and D, NVA237, Salmeterol fluticasone propionate
- 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
NVA237 (50µg, o.d. via SDDPI) in the morning,
Placebo to NVA237Drug
Placebo to NVA237
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo to NVA237 (50 μg) o.d. in the morning Patients will also receive open label salmeterol/fluticasone propionate (50/500 µg) b.i.d., in the morning and evening Receives: Drug: Placebo to NVA237 |
| NVA237 | Experimental | NVA237 (50 μg) o.d. in the morning Patients will also receive open label salmeterol/fluticasone propionate (50/500 µg) b.i.d., in the morning and evening. Receives: Drug: NVA237 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough Forced Expiratory Volume in 1 second (FEV1)
Comparison of NVA237 treatment versus placebo treatment in the trough FEV1 after 12 weeks of treatment
Measured: after 12 weeks of treatment
Secondary outcomes (4)
Total score of St George's Respiratory Questionnaire for COPD patients (SGRQ-C).
Comparison of NVA237 treatment versus placebo treatment in terms of change in SGRQ-C after 26 weeks of treatment
Measured: 26 weeks
Trough Forced Expiratory Volume in 1 second (FEV1)
Comparison of effect of NVA237 treatment versus placebo treatment in FEV1 after 4 weeks and after 26 weeks of treatment
Measured: week 4 , week 26
Total score of the Transition Dyspnea Index (TDI)
Comparison of effect of NVA237 treatment versus placebo treatment in the total TDI score after 12 weeks and after 26 weeks of treatment
Measured: Week 12 and week 26
Assessment of safety and tolerability
All safety endpoints will be summarized for the safety set.
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startApr 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT01757015
- Sponsor's protocol ID
- CNVA237A2311
- Other IDs
- 2012-002854-21
- Acronym
- GLOW8
- Status last verified
- Aug 2013
- First submitted
- 17 Dec 2012
- Last updated
- 20 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26-week Multi-center Randomized Double-blind Study to Compare Efficacy and Safety of NVA237 Versus Placebo as an add-on to Maintenance Therapy With Fixed-dose Combination Salmeterol/Fluticasone Propionate in COPD Patients With Moderate to Severe Airflow Limitation
- ClinicalTrials.gov ID
- NCT01757015
- Acronym / sponsor ID
- GLOW8 / CNVA237A2311
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Moderate to severe airflow limitation, GOLD spirometric classification 2 and 3, GOLD group B and D, NVA237, Salmeterol fluticasone propionate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 28 Dec 2012 (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 is to evaluate if add-on treatment with inhaled NVA237 (50 µg) once daily (o.d.) via single-dose dry-powder inhaler (SDDPI) further improves lung function and health status and is well tolerated compared to placebo in symptomatic COPD patients with moderate to severe airflow limitation who are already receiving maintenance therapy with inhaled fixed-dose-combination of salmeterol/fluticasone propionate (50/500 µg) twice daily (b.i.d.) via multi-dose dry powder inhaler (MDDPI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo to NVA237Placebo to NVA237 (50 μg) o.d. in the morning Patients will also receive open label salmeterol/fluticasone propionate (50/500 µg) b.i.d., in the morning and evening |
| NVA237 | Experimental | Drug: NVA237NVA237 (50 μg) o.d. in the morning Patients will also receive open label salmeterol/fluticasone propionate (50/500 µg) b.i.d., in the morning and evening. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Current or ex-smokers who have a smoking history of at least 10 pack years (e.g., 10 pack years = 1 pack/day × 10 years, ½ pack/day × 20 years, etc.).
- COPD (Chronic Obstructive Pulmonary Disease) patients with moderate to severe airflow limitation (Spirometry classification: GOLD 2 or 3) at Visit 2:
- Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) ≥30% and <60% of the predicted normal, and,
- Post-bronchodilator FEV1/forced vital capacity (FVC) <0.70
- Patients on maintenance treatment with fixed-dose combination of inhaled salmeterol and fluticasone propionate (50/500 µg) b.i.d. delivered via a proprietary MDDPI (multidose dry powder inhaler) device for at least 30 days prior to screening visit (Visit 1).
Key exclusion criteria (12 listed)
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unless they are using effective methods of contraception during the study
- Patients with a history of long QT syndrome or whose QTc measured at run-in (Visit 2) (Fridericia method) is prolonged (>450 ms). (These patients cannot be re-screened.)
- Patients with evidence (upon visual inspection) of oropharyngeal candidiasis at baseline with or without treatment.
- Patients who have not achieved an acceptable spirometry result at run-in (Visit 2) in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability and repeatability.
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 |
|---|---|---|
| NVA237NVA237 (50µg, o.d. via SDDPI) in the morning, | Drug | NVA237 |
| Placebo to NVA237Placebo to NVA237 | Drug | Placebo |
Primary outcome
Trough Forced Expiratory Volume in 1 second (FEV1)
Time frame: after 12 weeks of treatment
Comparison of NVA237 treatment versus placebo treatment in the trough FEV1 after 12 weeks of treatment
4 secondary outcomes
Total score of St George's Respiratory Questionnaire for COPD patients (SGRQ-C).
Time frame: 26 weeks
Trough Forced Expiratory Volume in 1 second (FEV1)
Time frame: week 4 , week 26
Total score of the Transition Dyspnea Index (TDI)
Time frame: Week 12 and week 26
Assessment of safety and tolerability
Time frame: 26 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 20 Apr 2017.
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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 in people with Chronic Obstructive Pulmonary Disease, 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 7 inclusion and 12 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 20 Apr 2017. 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. 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?
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?
Trough Forced Expiratory Volume in 1 second (FEV1) (time frame: after 12 weeks of 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 20 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.