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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01005901




Registration number
NCT01005901
Ethics application status
Date submitted
30/10/2009
Date registered
1/11/2009
Date last updated
12/04/2012

Titles & IDs
Public title
A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo
Scientific title
A 26-week Treatment, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Secondary ID [1] 0 0
2009-013504-32
Secondary ID [2] 0 0
CNVA237A2304
Universal Trial Number (UTN)
Trial acronym
GLOW 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Glycopyrronium bromide
Treatment: Drugs - Placebo

Experimental: Glycopyrronium bromide - Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At visit 1 all patients were provided with a short acting ß2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.

Placebo Comparator: Placebo - Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting ß2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.


Treatment: Drugs: Glycopyrronium bromide
Glycopyrronium bromide 50µg was supplied as inhalation capsules for use via a Single Dose Dry Powder Inhaler (SDDPI)

Treatment: Drugs: Placebo
Placebo inhalation capsules were provided for use via a SDDPI
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment
Timepoint [1] 0 0
26 weeks
Secondary outcome [2] 0 0
Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 26 Weeks of Treatment
Timepoint [2] 0 0
26 weeks
Secondary outcome [3] 0 0
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During 26 Weeks of Treatment
Timepoint [3] 0 0
26 weeks
Secondary outcome [4] 0 0
Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (Baseline to Week 26)
Timepoint [4] 0 0
26 weeks
Secondary outcome [5] 0 0
FEV1 at Each Time-point on Day 1 and Week 26
Timepoint [5] 0 0
Day 1 and Week 26
Secondary outcome [6] 0 0
Forced Vital Capacity (FVC) at Each Time-point on Day 1 and Week 26
Timepoint [6] 0 0
Day 1 and Week 26
Secondary outcome [7] 0 0
FEV1 Area Under the Curve (AUC) (5 Min - 12 Hour) at Day 1, Week 12 and Week 26
Timepoint [7] 0 0
Day 1, Week 12 and Week 26
Secondary outcome [8] 0 0
FEV1 Area Under Curve (AUC) (5 Min - 23 Hour 45 Min) at Week 12 and Week 26
Timepoint [8] 0 0
Week 12 and Week 26
Secondary outcome [9] 0 0
Trough FEV1 and FVC at Day 1 and Week 26
Timepoint [9] 0 0
Day 1 and Week 26
Secondary outcome [10] 0 0
Change in 24-hourly Mean Heart Rate at Day 1, Week 12 and Week 26
Timepoint [10] 0 0
Baseline, Day 1, Week 12 and Week 26
Secondary outcome [11] 0 0
Number of Participants With Adverse Events, Death, and Serious or Clinically Significant Adverse Events or Related Discontinuations
Timepoint [11] 0 0
26 Weeks and 30 Day follow-up
Secondary outcome [12] 0 0
Rate of Moderate or Severe COPD Exacerbations Over the 26 Week Treatment Period
Timepoint [12] 0 0
26 weeks
Secondary outcome [13] 0 0
Percentage of Nights With no Nighttime Awakenings Over the 26 Week Treatment Period
Timepoint [13] 0 0
26 Weeks
Secondary outcome [14] 0 0
Percentage of Days With no Daytime Symptoms Over the 26 Week Treatment Period
Timepoint [14] 0 0
26 Weeks
Secondary outcome [15] 0 0
Percentage of Days Able to Perform Usual Daily Activities Over the 26 Week Treatment Period
Timepoint [15] 0 0
26 Weeks
Secondary outcome [16] 0 0
Mean Daily Total Symptom Score Over the 26 Week Treatment Period
Timepoint [16] 0 0
26 Weeks

Eligibility
Key inclusion criteria
1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic
Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

- Smoking history of at least 10 pack-years

- Post-bronchodilator FEV1 < 80% and = 30% of the predicted normal value

- Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have had a lower respiratory tract infection within 6 weeks prior to
Visit 1

2. Patients with concomitant pulmonary disease

3. Patients with a history of asthma

4. Any patient with lung cancer or a history of lung cancer

5. Patients with a history of certain cardiovascular comorbid conditions

6. Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

7. Patients in the active phase of a supervised pulmonary rehabilitation program

8. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
1324
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Daw Park SA
Recruitment postcode(s) [1] 0 0
- Daw Park SA
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Rhode Island
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
Canada
State/province [25] 0 0
Nova Scotia
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Japan
State/province [28] 0 0
Asahikawa
Country [29] 0 0
Japan
State/province [29] 0 0
Hamakita
Country [30] 0 0
Japan
State/province [30] 0 0
Himeji
Country [31] 0 0
Japan
State/province [31] 0 0
Hitachi
Country [32] 0 0
Japan
State/province [32] 0 0
Kishiwada
Country [33] 0 0
Japan
State/province [33] 0 0
Kyoto
Country [34] 0 0
Japan
State/province [34] 0 0
Matsue
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Japan
State/province [35] 0 0
Matsusaka
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Japan
State/province [36] 0 0
Moriya
Country [37] 0 0
Japan
State/province [37] 0 0
Naka-gun
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Japan
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Obihiro
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Japan
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Osaka
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Japan
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Ota
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Japan
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Otsu
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Japan
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Sapporo
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Japan
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Takatsuki
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Japan
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Tokyo
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Japan
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Yabu
Country [46] 0 0
Japan
State/province [46] 0 0
Yonezawa
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Daegu
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Pusan
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Seoul
Country [50] 0 0
Netherlands
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Almelo
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Netherlands
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Eindhoven
Country [52] 0 0
Netherlands
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Harderwijk
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Netherlands
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Heerlen
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Netherlands
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Zutphen
Country [55] 0 0
Romania
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Bucharest
Country [56] 0 0
Romania
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Bucuresti
Country [57] 0 0
Romania
State/province [57] 0 0
Iasi
Country [58] 0 0
Romania
State/province [58] 0 0
Timisoara
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Irkutsk
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Russian Federation
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Kazan
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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N. Novgorod
Country [64] 0 0
Russian Federation
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Novosibirsk
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Russian Federation
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Sochy
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Russian Federation
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Stavropol
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Yaroslavl
Country [68] 0 0
Singapore
State/province [68] 0 0
Singapore
Country [69] 0 0
Spain
State/province [69] 0 0
Alicante
Country [70] 0 0
Spain
State/province [70] 0 0
Badalona
Country [71] 0 0
Spain
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Caceres
Country [72] 0 0
Spain
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Canet de Mar
Country [73] 0 0
Spain
State/province [73] 0 0
Centelles
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Spain
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Valencia
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Turkey
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Altunizade
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Turkey
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Aydin
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Turkey
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Diyarbakir
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Turkey
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Istanbul
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Turkey
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Izmir
Country [80] 0 0
Turkey
State/province [80] 0 0
Kinikli/Denizli
Country [81] 0 0
Turkey
State/province [81] 0 0
Mersin
Country [82] 0 0
Turkey
State/province [82] 0 0
Soke/Aydin
Country [83] 0 0
Turkey
State/province [83] 0 0
Yenisehir/Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients
with moderate-to-severe chronic obstructive pulmonary disease (COPD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01005901
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries