Chronic Obstructive Pulmonary DiseasePhase 3GLOW4NCT01119937
Long Term Safety and Tolerability of NVA237 Versus Tiotropium in Japanese Patients
A Phase 3 study testing NVA237 and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 40 sites in Japan.
Trial summary
This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) . 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 and Tiotropium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 40 sitesJapan
- Study dates
- May 2010to Nov 2011
- 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 Gold Guideline 2008.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and postbronchodilator FEV1/FVC < 0.7 at Visit 2 (day -7)
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 6 weeks prior to Visit 1
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Any patient with lung cancer or a history of lung cancer
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 tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Japan40 sites
Novartis Investigative Site
Asahikawa, Hokkaido, 070-8644
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8431
Novartis Investigative Site
Fukuoka, Fukuoka, 812-0033
Novartis Investigative Site
Himeji, Hyōgo, 672-8064
Novartis Investigative Site
Iizuka, Fukuoka, 820-8505
Novartis Investigative Site
Inashiki-gun, Ibaraki, 300-0395
Novartis Investigative Site
Kasaoka, Okayama-ken, 714-0081
Novartis Investigative Site
Kawasaki, Kanagawa, 210-0852
Novartis Investigative Site
Kitakyushu, Fukuoka, 802-0083
Novartis Investigative Site
Kitakyushu, Fukuoka, 820-0052
Novartis Investigative Site
Kochi, Kochi, 780-8077
Novartis Investigative Site
Kurume, Fukuoka, 830-0011
Novartis Investigative Site
Matsusaka, Mie-ken, 515-8544
Novartis Investigative Site
Morioka, Iwate, 020-0055
Novartis Investigative Site
Nagaoka, Niigata, 940-2085
Novartis Investigative Site
Nagaoka, Niigata, 940-8653
Novartis Investigative Site
Naka-gun, Ibaraki, 319-1113
Novartis Investigative Site
Nakano-ku, Tokyo, 164-0012
Novartis Investigative Site
Obihiro, Hokkaido, 080-0805
Novartis Investigative Site
Ohta-ku, Tokyo, 140-0063
Novartis Investigative Site
Ōnojō, Fukuoka, 816-0931
Novartis Investigative Site
Osaka, Osaka, 530-0012
Novartis Investigative Site
Osaka, Osaka, 545-8586
Novartis Investigative Site
Saitama, Saitama, 337-0012
Novartis Investigative Site
Sakai, Osaka, 591-8555
Novartis Investigative Site
Sapporo, Hokkaido, 060-8648
Novartis Investigative Site
Sashima-gun, Ibaraki, 306-0433
Novartis Investigative Site
Sayama, Osaka, 589-0022
Novartis Investigative Site
Sendai, Miyagi, 981-8563
Novartis Investigative Site
Shimotsuka-gun, Tochigi, 321-0293
Novartis Investigative Site
Takarazuka, Hyōgo, 665-0827
Novartis Investigative Site
Takatsuki, Osaka, 569-1096
Novartis Investigative Site
Tsuyama, Okayama-ken, 708-0841
Novartis Investigative Site
Ube, Yamaguchi, 755-0241
Novartis Investigative Site
Uji, Kyoto, 611-0042
Novartis Investigative Site
Yabu, Hyōgo, 667-8555
Novartis Investigative Site
Yamagata, Yamagata, 990-8533
Novartis Investigative Site
Yanagawa, Fukuoka, 832-0059
Novartis Investigative Site
Yokohama, Kanagawa, 232-0021
Novartis Investigative Site
Yokohama, Kanagawa, 236-0051
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 NVA237 (50µg o.d.) Using Tiotropium (18µg o.d.) as an Active Control in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) .
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- NVA237, Tiotropium
- Keywords
- COPD, NVA237
- 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
50µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®)
TiotropiumDrug
18µg capsules for inhalation, delivered via HandiHaler®
| Study group | Role | What they receive |
|---|---|---|
| NVA237 | Experimental | 50µg once daily Receives: Drug: NVA237 |
| Tiotropium | Experimental | 18µg once daily Receives: Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events, Serious Adverse Events or Death
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.
Measured: 52 weeks
Secondary outcomes (10)
Change in Pre-dose FEV1 From Baseline
Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 minutes pre-dose.
Measured: Weeks 12, 24, 36 and 52
Change in Pre-dose FVC From Baseline
Pre-dose FVC is defined as the average of the measurements at 45 and 15 minutes pre-dose.
Measured: Weeks 12, 24, 36 and 52
Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation
Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required. Participants who withdraw from the study and do not experience a moderate or severe exacerbation are censored at the date of withdrawal. Participants who complete the study and do not experience a moderate or severe exacerbation are censored at the completion visit date.
Measured: 52 weeks
Number of Patients With Moderate or Severe COPD Exacerbations
Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required.
Measured: 52 weeks
Change in St. George Respiratory Questionnaire From Baseline
SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
Measured: Weeks 12, 24, 36, 52
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over the Whole Treatment Period
Patients recorded rescue medication use in a paper patient diary. If a patient required the use of salbutamol as rescue medication due to an increase in COPD symptoms, the number of inhalations (puffs) taken was recorded in the patient diary.
Measured: 52 weeks
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
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole 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
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint 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
Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period
Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).
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 posted10 May 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- None (open label)
- Enrolment
- 211 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
- NCT01119937
- Sponsor's protocol ID
- CNVA237A1302
- Acronym
- GLOW4
- Status last verified
- Nov 2012
- First submitted
- 5 May 2010
- Last updated
- 18 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. 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 Long Term Safety and Tolerability of NVA237 (50µg o.d.) Using Tiotropium (18µg o.d.) as an Active Control in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01119937
- Acronym / sponsor ID
- GLOW4 / CNVA237A1302
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, NVA237
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Nov 2011 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Posted 18 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) .
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: NVA23750µg once daily |
| Tiotropium | Experimental | Drug: Tiotropium18µg 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)
- Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Gold Guideline 2008.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and postbronchodilator FEV1/FVC < 0.7 at Visit 2 (day -7)
Key exclusion criteria (11 listed)
- 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 6 weeks prior to Visit 1
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
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 |
|---|---|---|
| NVA23750µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®) | Drug | NVA237 |
| Tiotropium18µg capsules for inhalation, delivered via HandiHaler® | Drug | Tiotropium |
Primary outcome
Number of Participants With Adverse Events, Serious Adverse Events or Death
Time frame: 52 weeks
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.
10 secondary outcomes
Change in Pre-dose FEV1 From Baseline
Time frame: Weeks 12, 24, 36 and 52
Change in Pre-dose FVC From Baseline
Time frame: Weeks 12, 24, 36 and 52
Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation
Time frame: 52 weeks
Number of Patients With Moderate or Severe COPD Exacerbations
Time frame: 52 weeks
Change in St. George Respiratory Questionnaire From Baseline
Time frame: Weeks 12, 24, 36, 52
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over the Whole Treatment Period
Time frame: 52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Time frame: 52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Time frame: 52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Time frame: 52 weeks
Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NVA237 and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 40 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 18 Jan 2013. 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 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 18 Jan 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, Serious Adverse Events 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?
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 18 Jan 2013.