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

NCT01757015 | Withdrawn Phase 3

• 2 other identifiers: CNVA237A23112012-002854-21
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Chronic Obstructive Pulmonary Disease; Moderate to severe airflow limitation; GOLD spirometric classification 2 and 3; GOLD group B and D; NVA237; Salmeterol fluticasone propionate

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in 1 second (FEV1)

  Comparison of NVA237 treatment versus placebo treatment in the trough FEV1 after 12 weeks of treatment

  after 12 weeks of treatment

Secondary Outcomes (4)

• Total score of St George's Respiratory Questionnaire for COPD patients (SGRQ-C).

  26 weeks

• Trough Forced Expiratory Volume in 1 second (FEV1)

  week 4 , week 26

• Total score of the Transition Dyspnea Index (TDI)

  Week 12 and week 26

• Assessment of safety and tolerability

  26 Weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo to NVA237

NVA237

EXPERIMENTAL

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.

Drug: NVA237

Interventions

NVA237 DRUG

NVA237 (50µg, o.d. via SDDPI) in the morning,

NVA237

Placebo to NVA237 DRUG

Placebo to NVA237

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 28, 2012
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 20, 2017

Record last verified: 2013-08