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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
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Arizona
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California
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Delaware
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Florida
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Kansas
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Kentucky
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Louisiana
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Maine
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Maryland
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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Nevada
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New Jersey
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New York
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Ohio
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Oklahoma
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Rhode Island
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Tennessee
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Texas
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Virginia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Japan
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Asahikawa
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Japan
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Hamakita
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Japan
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Himeji
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Japan
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Hitachi
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Japan
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Kishiwada
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Kyoto
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Matsue
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Matsusaka
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Moriya
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Naka-gun
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Obihiro
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Osaka
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Ota
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Otsu
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Sapporo
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Takatsuki
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Tokyo
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Yabu
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Japan
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Yonezawa
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Korea, Republic of
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Daegu
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Korea, Republic of
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Pusan
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Korea, Republic of
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Seoul
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Netherlands
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Almelo
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Eindhoven
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Harderwijk
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Heerlen
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Netherlands
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Zutphen
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Iasi
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Romania
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Timisoara
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Russian Federation
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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
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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
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Russian Federation
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Yaroslavl
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Singapore
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Singapore
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Spain
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Alicante
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Spain
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Badalona
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Spain
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Caceres
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Spain
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Canet de Mar
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Spain
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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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Aydin
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Diyarbakir
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Istanbul
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Turkey
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Izmir
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Turkey
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Kinikli/Denizli
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Turkey
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Mersin
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Turkey
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Soke/Aydin
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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