Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Country [35] 0 0
Japan
State/province [35] 0 0
Matsusaka
Country [36] 0 0
Japan
State/province [36] 0 0
Moriya
Country [37] 0 0
Japan
State/province [37] 0 0
Naka-gun
Country [38] 0 0
Japan
State/province [38] 0 0
Obihiro
Country [39] 0 0
Japan
State/province [39] 0 0
Osaka
Country [40] 0 0
Japan
State/province [40] 0 0
Ota
Country [41] 0 0
Japan
State/province [41] 0 0
Otsu
Country [42] 0 0
Japan
State/province [42] 0 0
Sapporo
Country [43] 0 0
Japan
State/province [43] 0 0
Takatsuki
Country [44] 0 0
Japan
State/province [44] 0 0
Tokyo
Country [45] 0 0
Japan
State/province [45] 0 0
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
State/province [50] 0 0
Almelo
Country [51] 0 0
Netherlands
State/province [51] 0 0
Eindhoven
Country [52] 0 0
Netherlands
State/province [52] 0 0
Harderwijk
Country [53] 0 0
Netherlands
State/province [53] 0 0
Heerlen
Country [54] 0 0
Netherlands
State/province [54] 0 0
Zutphen
Country [55] 0 0
Romania
State/province [55] 0 0
Bucharest
Country [56] 0 0
Romania
State/province [56] 0 0
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
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Kazan
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Krasnodar
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Moscow
Country [63] 0 0
Russian Federation
State/province [63] 0 0
N. Novgorod
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Novosibirsk
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Sochy
Country [66] 0 0
Russian Federation
State/province [66] 0 0
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
State/province [71] 0 0
Caceres
Country [72] 0 0
Spain
State/province [72] 0 0
Canet de Mar
Country [73] 0 0
Spain
State/province [73] 0 0
Centelles
Country [74] 0 0
Spain
State/province [74] 0 0
Valencia
Country [75] 0 0
Turkey
State/province [75] 0 0
Altunizade
Country [76] 0 0
Turkey
State/province [76] 0 0
Aydin
Country [77] 0 0
Turkey
State/province [77] 0 0
Diyarbakir
Country [78] 0 0
Turkey
State/province [78] 0 0
Istanbul
Country [79] 0 0
Turkey
State/province [79] 0 0
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/study/NCT01005901
Trial related presentations / publications
D'Urzo A, Ferguson GT, van Noord JA, Hirata K, Martin C, Horton R, Lu Y, Banerji D, Overend T. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res. 2011 Dec 7;12(1):156. doi: 10.1186/1465-9921-12-156.
D'Urzo A, Kerwin E, Overend T, D'Andrea P, Chen H, Goyal P. Once daily glycopyrronium for the treatment of COPD: pooled analysis of the GLOW1 and GLOW2 studies. Curr Med Res Opin. 2014 Mar;30(3):493-508. doi: 10.1185/03007995.2013.858618. Epub 2013 Nov 19.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01005901