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Trial record 63 of 186 for:    GLYCOPYRROLATE

A Study to Assess the Long-term Safety of QVA149 (ENLIGHTEN)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01120717
Recruitment Status : Completed
First Posted : May 11, 2010
Results First Posted : January 21, 2013
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: QVA149
Drug: Placebo
Enrollment 339
Recruitment Details  
Pre-assignment Details Randomization ratio in the study was 2:1 for QVA149 and Placebo groups. Patients were not stratified by COPD disease severity.
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description 110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI) Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
Period Title: Overall Study
Started 226 113
Safety Population: Received Study Drug 225 113
Completed 194 89
Not Completed 32 24
Reason Not Completed
Withdrawal by Subject             11             6
Adverse Event             10             6
Protocol Deviation             2             5
Unsatisfactory Therapeutic Effect             3             3
Lost to Follow-up             2             3
Death             3             1
Abnormal Test Procedure Result(s)             1             0
Arm/Group Title QVA149 Placebo Total
Hide Arm/Group Description 110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI) Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI Total of all reporting groups
Overall Number of Baseline Participants 225 113 338
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 225 participants 113 participants 338 participants
62.5  (8.81) 62.9  (8.14) 62.6  (8.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 225 participants 113 participants 338 participants
Female
51
  22.7%
27
  23.9%
78
  23.1%
Male
174
  77.3%
86
  76.1%
260
  76.9%
1.Primary Outcome
Title Number of Participants With Adverse Events, Serious Adverse Events or Death
Hide Description 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.
Time Frame 52 weeks + Follow-up (Up to Day 394)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with safety assessments were included in this analysis.
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
Overall Number of Participants Analyzed 225 113
Measure Type: Number
Unit of Measure: participants
Adverse events 130 64
Serious adverse events 37 12
Death - 1st treatment day to 30d after last dose 4 1
Death - last dose + 30d until end of follow-up 1 0
2.Secondary Outcome
Title Pre-dose FEV1
Hide Description Pre-dose FEV1 is defined as the average of the FEV1 15 minutes pre-dose and FEV1 45 minutes pre-dose. A mixed model was used with treatment as a fixed effect, average of 15 min and 45 min pre-dose FEV1 at visit 3 as the baseline measurement, and FEV1 prior to inhalation and FEV1 60 min post inhalation of two short acting bronchodialators as covariates. The model also included smoking status at baseline, history of ICS use and country as fixed effects with center nested within country as a random effect.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all randomized patients who received at least one dose of study drug. Only patients with the required data were included in this analysis.
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
Overall Number of Participants Analyzed 191 88
Least Squares Mean (Standard Error)
Unit of Measure: Liter
1.607  (0.0230) 1.418  (0.0297)
3.Secondary Outcome
Title Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Hide Description Clinically notable hematology values were: hemoglobin - male <115g/L, female <95 g/L; hematocrit - male <0.37v/v, female <0.32v/v; white cell count - <2.8 10E9/L or >16.0 10E9/L; platelets - <75 10E9/L or >700 10E9/L
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
Overall Number of Participants Analyzed 225 113
Measure Type: Number
Unit of Measure: participants
Hemoglobin - male <115g/L (n = 164, 77) 9 1
Hemoglobin - female <95g/L (n = 50, 25) 0 0
Hematocrit - male <0.37v/v (n = 164, 77) 11 3
Hematocrit - female <0.32v/v (n = 49, 25) 0 0
WBC (total) - <2.8 10E9/L (n = 214, 102) 0 0
WBC (total) - >16.0 10E9/L (n = 214, 102) 0 0
Platelet count (direct) - <75 10E9/L (n = 214,102) 1 0
Platelet count (direct) - >700 10E9/L (n=214, 102) 0 0
4.Secondary Outcome
Title Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Hide Description Clinically notable biochemistry values were: sodium <125mmol/L or >160mmol/L; potassium <3.0mmol/L or >6.0mmol/L; BUN >9.99mmol/L; creatinine >176.8µmol/L; total protein (serum) <40g/L or >95g/L; albumin <25g/L; bilirubin (total) >34.2µmol/L; SGPT >3 x ULN; SGOT > 3 x ULN; gamma glutamyltransferase >3 x ULN; alkaline phosphatase (serum) >3 x ULN; glucose <2.78mmol/L or >9.99mmol/L
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
Overall Number of Participants Analyzed 214 101
Measure Type: Number
Unit of Measure: participants
Sodium - <125mmol/L 0 0
Sodium - >160mmol/L 0 0
Potassium - <3.0mmol/L 0 0
Potassium - >6.0mmol/L 2 1
BUN - >9.99mmol/L 14 4
Creatinine - >176.8µmol/L 1 1
Total protein (serum) - <40g/L 0 0
Total protein (serum) - >95g/L 0 0
Albumin - <25g/L 0 0
Bilirubin (total) - >34.2µmol/L (n = 213, 101) 0 0
SGPT - >3 x ULN 2 1
SGOT - >3 x ULN 1 2
Gamma glutamyltransferase - >3 x ULN 8 7
Alkaline phosphatase, serum - >3 x ULN 0 0
Glucose - <2.78mmol/L 0 0
Glucose - >9.99mmol/L 16 3
5.Secondary Outcome
Title Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Hide Description 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.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
Overall Number of Participants Analyzed 225 113
Measure Type: Number
Unit of Measure: participants
Pulse rate - low 0 1
Pulse rate - high 0 0
Systolic blood pressure - low 0 0
Systolic blood pressure - high 3 0
Diastolic blood pressure - low 0 3
Diastolic blood pressure - high 2 2
6.Secondary Outcome
Title Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period
Hide Description Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
Overall Number of Participants Analyzed 225 113
Measure Type: Number
Unit of Measure: participants
30 to 60ms change from baseline 7 5
> 60ms change from baseline 0 1
Time Frame Adverse Events were collected up to Day 394
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description 110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI) Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
All-Cause Mortality
QVA149 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
QVA149 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   37/225 (16.44%)   12/113 (10.62%) 
Blood and lymphatic system disorders     
Anaemia  1  0/225 (0.00%)  1/113 (0.88%) 
Cardiac disorders     
Cardiac failure congestive  1  2/225 (0.89%)  0/113 (0.00%) 
Cardio-respiratory arrest  1  1/225 (0.44%)  0/113 (0.00%) 
Coronary artery disease  1  1/225 (0.44%)  0/113 (0.00%) 
Myocardial ischaemia  1  1/225 (0.44%)  0/113 (0.00%) 
Sinus tachycardia  1  1/225 (0.44%)  0/113 (0.00%) 
Supraventricular tachycardia  1  1/225 (0.44%)  0/113 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/225 (0.44%)  0/113 (0.00%) 
Vestibular disorder  1  0/225 (0.00%)  1/113 (0.88%) 
Endocrine disorders     
Autoimmune thyroiditis  1  1/225 (0.44%)  0/113 (0.00%) 
Gastrointestinal disorders     
Bezoar  1  1/225 (0.44%)  0/113 (0.00%) 
Gastric ulcer  1  0/225 (0.00%)  1/113 (0.88%) 
Gastric ulcer haemorrhage  1  0/225 (0.00%)  1/113 (0.88%) 
Pancreatitis acute  1  1/225 (0.44%)  0/113 (0.00%) 
Volvulus  1  0/225 (0.00%)  1/113 (0.88%) 
Immune system disorders     
Drug hypersensitivity  1  1/225 (0.44%)  0/113 (0.00%) 
Infections and infestations     
Lower respiratory tract infection  1  1/225 (0.44%)  0/113 (0.00%) 
Pneumonia  1  8/225 (3.56%)  0/113 (0.00%) 
Pulmonary tuberculosis  1  1/225 (0.44%)  0/113 (0.00%) 
Respiratory tract infection viral  1  0/225 (0.00%)  1/113 (0.88%) 
Upper respiratory tract infection  1  1/225 (0.44%)  1/113 (0.88%) 
Upper respiratory tract infection bacterial  1  1/225 (0.44%)  0/113 (0.00%) 
Urinary tract infection  1  1/225 (0.44%)  0/113 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  1/225 (0.44%)  0/113 (0.00%) 
Femoral neck fracture  1  1/225 (0.44%)  0/113 (0.00%) 
Foot fracture  1  1/225 (0.44%)  0/113 (0.00%) 
Hip fracture  1  1/225 (0.44%)  0/113 (0.00%) 
Road traffic accident  1  0/225 (0.00%)  1/113 (0.88%) 
Spinal compression fracture  1  0/225 (0.00%)  1/113 (0.88%) 
Spinal fracture  1  1/225 (0.44%)  0/113 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma pancreas  1  0/225 (0.00%)  1/113 (0.88%) 
Basal cell carcinoma  1  1/225 (0.44%)  0/113 (0.00%) 
Bladder cancer  1  1/225 (0.44%)  0/113 (0.00%) 
Bladder neoplasm  1  1/225 (0.44%)  0/113 (0.00%) 
Hepatic neoplasm malignant  1  0/225 (0.00%)  1/113 (0.88%) 
Lung neoplasm  1  1/225 (0.44%)  0/113 (0.00%) 
Lung neoplasm malignant  1  2/225 (0.89%)  1/113 (0.88%) 
Metastases to central nervous system  1  1/225 (0.44%)  0/113 (0.00%) 
Prostatic adenoma  1  1/225 (0.44%)  0/113 (0.00%) 
Nervous system disorders     
Intracranial pressure increased  1  1/225 (0.44%)  0/113 (0.00%) 
Transient ischaemic attack  1  1/225 (0.44%)  0/113 (0.00%) 
Renal and urinary disorders     
Urinary retention  1  1/225 (0.44%)  0/113 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/225 (0.44%)  0/113 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  12/225 (5.33%)  4/113 (3.54%) 
Lung disorder  1  0/225 (0.00%)  1/113 (0.88%) 
Pneumothorax  1  1/225 (0.44%)  0/113 (0.00%) 
Vascular disorders     
Essential hypertension  1  1/225 (0.44%)  0/113 (0.00%) 
Hypertension  1  1/225 (0.44%)  0/113 (0.00%) 
Thrombosis  1  1/225 (0.44%)  0/113 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
QVA149 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   82/225 (36.44%)   41/113 (36.28%) 
Infections and infestations     
Lower respiratory tract infection  1  14/225 (6.22%)  4/113 (3.54%) 
Upper respiratory tract infection  1  11/225 (4.89%)  8/113 (7.08%) 
Viral upper respiratory tract infection  1  18/225 (8.00%)  15/113 (13.27%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  56/225 (24.89%)  27/113 (23.89%) 
Cough  1  18/225 (8.00%)  7/113 (6.19%) 
Vascular disorders     
Hypertension  1  3/225 (1.33%)  6/113 (5.31%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01120717     History of Changes
Other Study ID Numbers: CQVA149A2307
2009-013235-38 ( EudraCT Number )
First Submitted: May 5, 2010
First Posted: May 11, 2010
Results First Submitted: December 13, 2012
Results First Posted: January 21, 2013
Last Update Posted: January 31, 2013