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Safety and Efficacy of NVA237 as an add-on to Fixed Dose Combination LABA/ICS (GLOW8)

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: NCT01757015
Recruitment Status : Withdrawn
First Posted : December 28, 2012
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE December 17, 2012
First Posted Date  ICMJE December 28, 2012
Last Update Posted Date April 20, 2017
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2012)
Trough Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: after 12 weeks of treatment ]
Comparison of NVA237 treatment versus placebo treatment in the trough FEV1 after 12 weeks of treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • Total score of St George's Respiratory Questionnaire for COPD patients (SGRQ-C). [ Time Frame: 26 weeks ]
    Comparison of NVA237 treatment versus placebo treatment in terms of change in SGRQ-C after 26 weeks of treatment
  • Trough Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: week 4 , week 26 ]
    Comparison of effect of NVA237 treatment versus placebo treatment in FEV1 after 4 weeks and after 26 weeks of treatment
  • Total score of the Transition Dyspnea Index (TDI) [ Time Frame: Week 12 and week 26 ]
    Comparison of effect of NVA237 treatment versus placebo treatment in the total TDI score after 12 weeks and after 26 weeks of treatment
  • Assessment of safety and tolerability [ Time Frame: 26 Weeks ]
    All safety endpoints will be summarized for the safety set.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2012)
  • Total score of St George's Respiratory Questionnaire for COPD patients (SGRQ-C). [ Time Frame: 26 weeks ]
    Comparison of NVA237 treatment versus placebo treatment in terms of change in SGRQ-C after 26 weeks of treatment
  • Trough Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: week 4 , week 26 ]
    Comparison of effect of NVA237 treatment versus placebo treatment in FEV1 after 4 weeks and after 26 weeks of treatment
  • Total score of the Transition Dyspnea Index (TDI) [ Time Frame: Week 12 and week 26 ]
    Comparison of effect of NVA237 treatment versus placebo treatment in the total TDI score after 12 weeks and after 26 weeks of treatment
  • Number of AEs [ Time Frame: 26 Weeks ]
    All AEs and safety assessments will be reported
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of NVA237 as an add-on to Fixed Dose Combination LABA/ICS
Official Title  ICMJE A 26-week Multi-center Randomized Double-blind Study to Compare Efficacy and Safety of NVA237 Versus Placebo as an add-on to Maintenance Therapy With Fixed-dose Combination Salmeterol/Fluticasone Propionate in COPD Patients With Moderate to Severe Airflow Limitation
Brief Summary This study is to evaluate if add-on treatment with inhaled NVA237 (50 µg) once daily (o.d.) via single-dose dry-powder inhaler (SDDPI) further improves lung function and health status and is well tolerated compared to placebo in symptomatic COPD patients with moderate to severe airflow limitation who are already receiving maintenance therapy with inhaled fixed-dose-combination of salmeterol/fluticasone propionate (50/500 µg) twice daily (b.i.d.) via multi-dose dry powder inhaler (MDDPI).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: NVA237
    NVA237 (50µg, o.d. via SDDPI) in the morning,
  • Drug: Placebo to NVA237
    Placebo to NVA237
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo to NVA237 (50 μg) o.d. in the morning Patients will also receive open label salmeterol/fluticasone propionate (50/500 µg) b.i.d., in the morning and evening
    Intervention: Drug: Placebo to NVA237
  • Experimental: NVA237
    NVA237 (50 μg) o.d. in the morning Patients will also receive open label salmeterol/fluticasone propionate (50/500 µg) b.i.d., in the morning and evening.
    Intervention: Drug: NVA237
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 26, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2012)
1120
Estimated Study Completion Date  ICMJE April 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Current or ex-smokers who have a smoking history of at least 10 pack years (e.g., 10 pack years = 1 pack/day × 10 years, ½ pack/day × 20 years, etc.).
  • COPD (Chronic Obstructive Pulmonary Disease) patients with moderate to severe airflow limitation (Spirometry classification: GOLD 2 or 3) at Visit 2:
  • Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) ≥30% and <60% of the predicted normal, and,
  • Post-bronchodilator FEV1/forced vital capacity (FVC) <0.70
  • Patients on maintenance treatment with fixed-dose combination of inhaled salmeterol and fluticasone propionate (50/500 µg) b.i.d. delivered via a proprietary MDDPI (multidose dry powder inhaler) device for at least 30 days prior to screening visit (Visit 1).
  • Patients in category Gold B or D with a CAT (COPD Assessment Test) total score ≥10 at screening (Visit 1) and before randomization (Visit 3).
  • Patients with a history of at least 1 moderate or severe COPD exacerbation within the previous year.

Exclusion Criteria:

  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, unless they are using effective methods of contraception during the study
  • Patients with a history of long QT syndrome or whose QTc measured at run-in (Visit 2) (Fridericia method) is prolonged (>450 ms). (These patients cannot be re-screened.)
  • Patients with evidence (upon visual inspection) of oropharyngeal candidiasis at baseline with or without treatment.
  • Patients who have not achieved an acceptable spirometry result at run-in (Visit 2) in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability and repeatability.
  • Patients who have had a COPD exacerbation that required treatment with antibiotics or oral corticosteroids or hospitalization in the 6 weeks prior to screening (Visit 1).
  • Patients who have had a respiratory tract infection within 4 weeks prior to screening (Visit 1).
  • Patients requiring long term oxygen therapy prescribed for >12 hours per day.
  • Patients with allergic rhinitis who use an H1 antagonist or intra-nasal corticosteroids intermittently. (Treatment with a stable dose or regimen is permitted.)
  • Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, or pulmonary hypertension), clinically significant bronchiectasis, or history of pulmonary lobectomy, lung volume reduction surgery, or lung transplantation.
  • Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active.

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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01757015
Other Study ID Numbers  ICMJE CNVA237A2311
2012-002854-21
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 August 2013

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