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Randomized, Double-blind, Placebo-controlled, Multicenter, Cross-over Study to Assess the Effects of a 3 Week Therapy Each With QVA149 Versus Placebo on Pulmonary Function and Average Physical Activity Levels in Patients With COPD. (MOVE)

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ClinicalTrials.gov Identifier: NCT01996319
Recruitment Status : Completed
First Posted : November 27, 2013
Results First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: QVA149
Drug: Placebo
Enrollment 194
Recruitment Details  
Pre-assignment Details  
Arm/Group Title QVA149 Then Placebo Placebo Then QVA149
Hide Arm/Group Description QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
Period Title: Overall Study
Started 96 98
Completed 88 95
Not Completed 8 3
Reason Not Completed
Protocol Violation             1             0
Severe or moderate (COPD) Exacerbation             5             1
Adverse Event             2             2
Arm/Group Title QVA149 Then Placebo Placebo Then QVA149 Total
Hide Arm/Group Description QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days Total of all reporting groups
Overall Number of Baseline Participants 96 98 194
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 98 participants 194 participants
64.3  (7.9) 61.2  (7.7) 62.8  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 98 participants 194 participants
Female
32
  33.3%
35
  35.7%
67
  34.5%
Male
64
  66.7%
63
  64.3%
127
  65.5%
1.Primary Outcome
Title Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo
Hide Description Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
Time Frame Baseline, day 22, baseline day 36, day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. all patients were included in these analyses when baseline and day 22 data plus baseline day 36 and day 57 data were available.
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 189 184
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.3790
(0.3464 to 0.4117)
0.1769
(0.1379 to 0.2159)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVA149, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter null hypoth
Estimated Value 0.2021
Confidence Interval (2-Sided) 95%
0.1583 to 0.2460
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level
Hide Description Average physical activity level is defined by average daily activity-related energy consumption [Kcal/day], measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
Time Frame Baseline, day 22, baseline day 36, day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis.
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 175 170
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kcal/day
5.1063
(-24.4000 to 34.6125)
-31.6063
(-61.5268 to -1.6857)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVA149, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0399
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Null hypoth
Estimated Value 36.7126
Confidence Interval (2-Sided) 95%
1.7241 to 71.7011
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in the Comparison of QVA149 vs. Placebo on the Average Number of Steps Per Day
Hide Description The average number of steps per day will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day 1 or Day 57-Day36
Time Frame Baseline, day 22, baseline day 36, day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 178 173
Mean (Standard Deviation)
Unit of Measure: Steps/day
30.7  (1662) -320.7  (1648)
4.Secondary Outcome
Title Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo
Hide Description Least moderate activity (defined as 3,5-7kcal/min) will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
Time Frame Baseline, day 22, baseline day 36, day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22, plus baseline day 36 and day 57 data were included in this analysis.
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 178 173
Mean (Standard Deviation)
Unit of Measure: Minutes
-5.5  (51.8) -13.0  (52.3)
5.Secondary Outcome
Title Change From Baseline in Peak IC Comparison Between QVA149 and Placebo on Day 1.
Hide Description Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The IC measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days
Time Frame Day 1 or day 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 1 post treatment initiation were included in this analysis.
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 193 186
Mean (Standard Deviation)
Unit of Measure: Liters
0.486  (0.2752) 0.207  (0.2114)
6.Secondary Outcome
Title Change From Baseline in the Trough IC Comparison Between QVA149 and Placebo
Hide Description Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
Time Frame Baseline, day 22, baseline day 36, day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 20 post treatment initiation were included in this analysis.
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 190 183
Mean (Standard Deviation)
Unit of Measure: Liters
0.210  (0.346) -0.035  (0.279)
7.Secondary Outcome
Title Peak Forced Expiratory Volume 1 (FEV1) Comparison Between QVA149 and Placebo at Day 1
Hide Description FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The FEV1 measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days
Time Frame Day 1 or day 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 192 186
Mean (Standard Deviation)
Unit of Measure: Liters
0.347  (0.176) 0.111  (0.179)
8.Secondary Outcome
Title Trough FEV1 Comparison Between QVA149 and Placebo After 22 Days
Hide Description FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the FEV1 measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36
Time Frame Baseline, day 22, baseline day 36, day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period
Arm/Group Title QVA149 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 188 183
Mean (Standard Deviation)
Unit of Measure: Liters
0.245  (0.221) -0.058  (0.207)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QVA149 Then Placebo Placebo Then QVA149
Hide Arm/Group Description QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
All-Cause Mortality
QVA149 Then Placebo Placebo Then QVA149
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
QVA149 Then Placebo Placebo Then QVA149
Affected / at Risk (%) Affected / at Risk (%)
Total   4/193 (2.07%)   2/188 (1.06%) 
Cardiac disorders     
Myocardial infarction  1  1/193 (0.52%)  0/188 (0.00%) 
Infections and infestations     
Cellulitis  1  1/193 (0.52%)  0/188 (0.00%) 
Injury, poisoning and procedural complications     
Incisional hernia  1  1/193 (0.52%)  1/188 (0.53%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bone cancer  1  1/193 (0.52%)  0/188 (0.00%) 
Oesophageal carcinoma  1  0/193 (0.00%)  1/188 (0.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
QVA149 Then Placebo Placebo Then QVA149
Affected / at Risk (%) Affected / at Risk (%)
Total   27/193 (13.99%)   19/188 (10.11%) 
General disorders     
Fatigue  1  2/193 (1.04%)  0/188 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  7/193 (3.63%)  8/188 (4.26%) 
Rhinitis  1  2/193 (1.04%)  2/188 (1.06%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  3/193 (1.55%)  3/188 (1.60%) 
Nervous system disorders     
Headache  1  6/193 (3.11%)  3/188 (1.60%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/193 (4.15%)  3/188 (1.60%) 
Dyspnoea  1  2/193 (1.04%)  1/188 (0.53%) 
Oropharyngeal pain  1  2/193 (1.04%)  0/188 (0.00%) 
Sputum increased  1  3/193 (1.55%)  0/188 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 18.1
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 or disclosure of trial results in their entirety
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: NCT01996319    
Other Study ID Numbers: CQVA149ADE03
First Submitted: November 15, 2013
First Posted: November 27, 2013
Results First Submitted: January 25, 2016
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016