Long Term Safety and Tolerability of NVA237 Versus Tiotropium in Japanese Patients (GLOW4)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01119937
First received: May 5, 2010
Last updated: December 12, 2012
Last verified: November 2012
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Purpose
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) .
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: NVA237 Drug: Tiotropium |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Tiotropium bromide
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Number of Participants With Adverse Events, Serious Adverse Events or Death [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Change in Pre-dose FEV1 From Baseline [ Time Frame: Weeks 12, 24, 36 and 52 ] [ Designated as safety issue: No ]Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 minutes pre-dose.
- Change in Pre-dose FVC From Baseline [ Time Frame: Weeks 12, 24, 36 and 52 ] [ Designated as safety issue: No ]Pre-dose FVC is defined as the average of the measurements at 45 and 15 minutes pre-dose.
- Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]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.
- Number of Patients With Moderate or Severe COPD Exacerbations [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]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.
- Change in St. George Respiratory Questionnaire From Baseline [ Time Frame: Weeks 12, 24, 36, 52 ] [ Designated as safety issue: No ]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.
- Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over the Whole Treatment Period [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]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.
- Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]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
- Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]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
- 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 ] [ Designated as safety issue: Yes ]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.
- 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 ] [ Designated as safety issue: Yes ]Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).
| Enrollment: | 211 |
| Study Start Date: | May 2010 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: NVA237
50µg once daily
|
Drug: NVA237
50µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®)
|
|
Experimental: Tiotropium
18µg once daily
|
Drug: Tiotropium
18µg capsules for inhalation, delivered via HandiHaler®
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119937
Locations
| Japan | |
| Novartis Investigative Site | |
| Iizuka, Fukuoka, Japan, 820-8505 | |
| Novartis Investigative Site | |
| Kitakyushu, Fukuoka, Japan, 802-0083 | |
| Novartis Investigative Site | |
| Kitakyushu, Fukuoka, Japan, 820-0052 | |
| Novartis Investigative Site | |
| Kurume, Fukuoka, Japan, 830-0011 | |
| Novartis Investigative Site | |
| Onojo, Fukuoka, Japan, 816-0931 | |
| Novartis Investigative Site | |
| Yanagawa, Fukuoka, Japan, 832-0059 | |
| Novartis Investigative Site | |
| Asahikawa, Hokkaido, Japan, 070-8644 | |
| Novartis Investigative Site | |
| Obihiro, Hokkaido, Japan, 080-0805 | |
| Novartis Investigative Site | |
| Sapporo, Hokkaido, Japan, 060-8648 | |
| Novartis Investigative Site | |
| Himeji-city, Hyogo, Japan, 672-8064 | |
| Novartis Investigative Site | |
| Takarazuka, Hyogo, Japan, 665-0827 | |
| Novartis Investigative Site | |
| Yabu, Hyogo, Japan, 667-8555 | |
| Novartis Investigative Site | |
| Inashiki-gun, Ibaraki, Japan, 300-0395 | |
| Novartis Investigative Site | |
| Naka-gun, Ibaraki, Japan, 319-1113 | |
| Novartis Investigative Site | |
| Sashima-gun, Ibaraki, Japan, 306-0433 | |
| Novartis Investigative Site | |
| Morioka, Iwate, Japan, 020-0055 | |
| Novartis Investigative Site | |
| Kawasaki, Kanagawa, Japan, 210-0852 | |
| Novartis Investigative Site | |
| Yokohama, Kanagawa, Japan, 232-0021 | |
| Novartis Investigative Site | |
| Yokohama, Kanagawa, Japan, 236-0051 | |
| Novartis Investigative Site | |
| Uji, Kyoto, Japan, 611-0042 | |
| Novartis Investigative Site | |
| Matsusaka-city, Mie, Japan, 515-8544 | |
| Novartis Investigative Site | |
| Sendai, Miyagi, Japan, 981-8563 | |
| Novartis Investigative Site | |
| Nagaoka, Niigata, Japan, 940-8653 | |
| Novartis Investigative Site | |
| Nagaoka-City, Niigata, Japan, 940-2085 | |
| Novartis Investigative Site | |
| Kasaoka, Okayama, Japan, 714-0081 | |
| Novartis Investigative Site | |
| Tsuyama, Okayama, Japan, 708-0841 | |
| Novartis Investigative Site | |
| Osakasayama, Osaka, Japan, 589-0022 | |
| Novartis Investigative Site | |
| Sakai, Osaka, Japan, 591-8555 | |
| Novartis Investigative Site | |
| Takatsuki, Osaka, Japan, 569-1096 | |
| Novartis Investigative Site | |
| Shimotsuka-gun, Tochigi, Japan, 321-0293 | |
| Novartis Investigative Site | |
| Bunkyo-ku, Tokyo, Japan, 113-8431 | |
| Novartis Investigative Site | |
| Nakano-ku, Tokyo, Japan, 164-0012 | |
| Novartis Investigative Site | |
| Ohta-ku, Tokyo, Japan, 140-0063 | |
| Novartis Investigative Site | |
| Yamagata city, Yamagata, Japan, 990-8533 | |
| Novartis Investigative Site | |
| Ube, Yamaguchi, Japan, 755-0241 | |
| Novartis Investigative Site | |
| Fukuoka, Japan, 812-0033 | |
| Novartis Investigative Site | |
| Kochi, Japan, 780-8077 | |
| Novartis Investigative Site | |
| Osaka, Japan, 530-0012 | |
| Novartis Investigative Site | |
| Osaka, Japan, 545-8586 | |
| Novartis Investigative Site | |
| Saitama, Japan, 337-0012 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01119937 History of Changes |
| Other Study ID Numbers: | CNVA237A1302 |
| Study First Received: | May 5, 2010 |
| Results First Received: | November 20, 2012 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Food and Drug Administration Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Novartis:
|
COPD NVA237 |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Tiotropium Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013