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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 )

Brief Summary:
This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: QVA149 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: MOVE - A 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 Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : April 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015


Arm Intervention/treatment
Active Comparator: Treatment sequence I
QVA149 once a day during 21 days cross-over to placebo once a day for up to 21 days
Drug: QVA149
QVA149 (110/50 µg) once a day via Breezhaler® device

Drug: Placebo
Placebo once a day via Breezhaler® device

Active Comparator: Treatment sequence II
Placebo once a day during 21 days cross-over to QVA149 once a day for 21 days
Drug: QVA149
QVA149 (110/50 µg) once a day via Breezhaler® device

Drug: Placebo
Placebo once a day via Breezhaler® device




Primary Outcome Measures :
  1. Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo [ Time Frame: Baseline, day 22, baseline day 36, day 57 ]
    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

  2. Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level [ Time Frame: Baseline, day 22, baseline day 36, day 57 ]
    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


Secondary Outcome Measures :
  1. Change in the Comparison of QVA149 vs. Placebo on the Average Number of Steps Per Day [ Time Frame: Baseline, day 22, baseline day 36, day 57 ]
    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

  2. Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo [ Time Frame: Baseline, day 22, baseline day 36, day 57 ]
    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

  3. Change From Baseline in Peak IC Comparison Between QVA149 and Placebo on Day 1. [ Time Frame: Day 1 or day 36 ]
    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

  4. Change From Baseline in the Trough IC Comparison Between QVA149 and Placebo [ Time Frame: Baseline, day 22, baseline day 36, day 57 ]
    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

  5. Peak Forced Expiratory Volume 1 (FEV1) Comparison Between QVA149 and Placebo at Day 1 [ Time Frame: Day 1 or day 36 ]
    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

  6. Trough FEV1 Comparison Between QVA149 and Placebo After 22 Days [ Time Frame: Baseline, day 22, baseline day 36, day 57 ]
    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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with stable COPD according to the current GOLD guidelines (GOLD 2013). Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs)..

Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥40% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC <0.70

Exclusion Criteria:

Patients with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof, anticholinergics, long and short acting beta2 agonists, sympathomimetic amines, lactose or any of the other excipients Patients who have a clinically significant ECG abnormality at Visit 1, who in the judgment of the investigator would be at potential risk if enrolled into the study.

Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at baseline and screening visits, with a resting ventricular rate < 100/min.

Patients with Type I or uncontrolled Type II diabetes and patients with a history of blood glucose levels consistently outside the normal range Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention.

Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with non-melanoma skin carcinoma may be considered for the study.

Patients with a body mass index (BMI) of more than 40 kg/m2. Women who are pregnant or breast feeding Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.

Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening.

Patients who have had a respiratory tract infection within 4 weeks prior to screening.

Patients with any history of asthma. Patients with concomitant pulmonary disease Patients with clinically significant bronchiectasis. Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996319


Locations
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Germany
Novartis Investigative Site
Koblenz, NRW, Germany, 56068
Novartis Investigative Site
Cottbus, Sachsen, Germany, 03050
Novartis Investigative Site
Geesthacht, Schleswig Holstein, Germany, 12502
Novartis Investigative Site
Aschaffenburg, Germany, 63739
Novartis Investigative Site
Berlin, Germany, 10119
Novartis Investigative Site
Berlin, Germany, 10629
Novartis Investigative Site
Berlin, Germany, 12203
Novartis Investigative Site
Dueren, Germany, 52349
Novartis Investigative Site
Erlangen, Germany, 91052
Novartis Investigative Site
Euskirchen, Germany, 53879
Novartis Investigative Site
Grosshansdorf, Germany, 22947
Novartis Investigative Site
Hamburg, Germany, 20354
Novartis Investigative Site
Heidelberg, Germany, 69117
Novartis Investigative Site
Höchstadt, Germany, 91315
Novartis Investigative Site
Kassel, Germany, 34121
Novartis Investigative Site
Köln, Germany, 51605
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Leipzig, Germany, 04207
Novartis Investigative Site
Lübeck, Germany, 23552
Novartis Investigative Site
Lübeck, Germany, 23558
Novartis Investigative Site
Marburg, Germany, 35037
Novartis Investigative Site
Münster, Germany, 48145
Novartis Investigative Site
Neunkirchen, Germany, 66539
Novartis Investigative Site
Potsdam, Germany, 14467
Novartis Investigative Site
Potsdam, Germany, 14469
Novartis Investigative Site
Rheine, Germany, 48431
Novartis Investigative Site
Rüdersdorf, Germany, 15562
Novartis Investigative Site
Saarbruecken, Germany, 66111
Novartis Investigative Site
Teterow, Germany, 17166
Novartis Investigative Site
Wiesloch, Germany, 69168
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01996319    
Other Study ID Numbers: CQVA149ADE03
First Posted: November 27, 2013    Key Record Dates
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016
Last Verified: March 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic obstructive pulmonary disease
COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases