Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01996319
Previous Study | Return to List | Next Study

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)

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: 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 )

Tracking Information
First Submitted Date  ICMJE November 15, 2013
First Posted Date  ICMJE November 27, 2013
Results First Submitted Date  ICMJE January 25, 2016
Results First Posted Date  ICMJE April 5, 2016
Last Update Posted Date April 5, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
  • Change in Peak inspiratory capacity (IC) for QVA149 and Placebo [ Time Frame: Baseline and day 21 ]
    Change in peak 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 each time.
  • Change in Average physical activity level for QVA149 versus placebo [ Time Frame: Baseline, day 15, baseline day 35, day 56 ]
    Change in average physical activity level for QVA149 versus placebo will be defined by average daily activity-related energy consumption [Kcal/day], measured via Actinography device.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2016)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
  • Change in average number of steps per day for QVA149 vs. placebo [ Time Frame: Baseline, day 15, baseline day 35, day 56 ]
    Change in average number of steps per day for QVA149 vs. placebo will be measured via Actinography device.
  • Change on the duration of at least moderate activity per day for QVA149 versus placebo [ Time Frame: Baseline, day 15, baseline day 35, day 56 ]
    Change on the duration of at least moderate activity per day for QVA149 versus placebo (defined as 3,5-7kcal/min) will be measured via Actinography device.
  • Peak Inspiratory capacity (IC) comparison between QVA149 and Placebo on day 1. [ Time Frame: Day 1 ]
    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.
  • Trough Inspiratory capacity (IC) comparison between QVA149 and Placebo on day 20 [ Time Frame: Day 20 ]
    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.
  • Peak forced expiratory volume 1 (FEV1) comparison between QVA149 and Placebo on day 1 [ Time Frame: Day 1 ]
    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.
  • Trough Forced Expiratory Volume in 1 second (FEV1) comparison between QVA149 and placebo on day 20 [ Time Frame: Day 20 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: QVA149
    QVA149 (110/50 µg) once a day via Breezhaler® device
  • Drug: Placebo
    Placebo once a day via Breezhaler® device
Study Arms  ICMJE
  • Active Comparator: Treatment sequence I
    QVA149 once a day during 21 days cross-over to placebo once a day for up to 21 days
    Interventions:
    • Drug: QVA149
    • Drug: Placebo
  • Active Comparator: Treatment sequence II
    Placebo once a day during 21 days cross-over to QVA149 once a day for 21 days
    Interventions:
    • Drug: QVA149
    • Drug: Placebo
Publications * Watz H, Mailänder C, Baier M, Kirsten A. Effects of indacaterol/glycopyrronium (QVA149) on lung hyperinflation and physical activity in patients with moderate to severe COPD: a randomised, placebo-controlled, crossover study (The MOVE Study). BMC Pulm Med. 2016 Jun 14;16(1):95. doi: 10.1186/s12890-016-0256-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2016)
194
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2013)
150
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01996319
Other Study ID Numbers  ICMJE CQVA149ADE03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP