Single Dose Ultibro Breezhaler by Sd-DPI Versus Ipratropium/Salbutamol by Nebulizer in COPD

NCT ID: NCT02576626

Last Updated: 2017-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-09-29

Brief Summary

Rationale:

Inhaled bronchodilators, beta-2-agonist or anticholinergic or combinations, can be delivered by several types of devices: dry powder (DPI), pressurized metered dose inhalers (pMDI), and wet nebulizers. Wet nebulization is available for short-acting bronchodilators only, is cumbersome, and, importantly, has never been scientifically been proven to be more efficacious than delivery by the other two methods. Yet many patients are happy with wet nebulization and in many clinics this administration method prevails. The investigators believe that combined long-acting bronchodilators, are more efficacious than combined short acting bronchodilators per nebulizers.

Objective:

To test the hypothesis that: The combination of the two long-acting bronchodilators indacaterol and glycopyrronium by dry powder inhalation confers a superior improvement compared to nebulisation with ipratropium/salbutamol, when administered as single dose in patients with stable state chronic obstructive pulmonary disease (COPD).

Study design: Investigator initiated, randomised, active controlled, cross-over double-blind (and therefore double-dummy), study comparing the effects of single dose indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol nebulisation in patients with COPD in stable state Study population: Patients visiting the outpatient clinics or from general practitioner (GP) practices with COPD GOLD stage A-D, and (FEV1) post-bronchodilator FEV1/ forced vital capacity (FVC) < 70%; post-br FEV1 < 80%pred. Intervention The investigators will compare the effects of single dose indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol nebulisation in patients with COPD in stable state

Main study parameters/endpoints:

Area under the curve (AUC) from 0 to 6 hours of FEV1 with indacaterol and glycopyrronium, compared to nebulisation with ipratropium/salbutamol

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

This study has no specific benefits for the participating patients. The study also has no major risks. Minor risks for participants after a single dosis can be throat irritation, cough, headache and dizziness, sinus tachycardia. The combination of treatments with β2-agonist bronchodilators and anticholinergic bronchodilators have been used in daily practice for many years in many countries and they are often prescribed both in COPD. Both indacaterol/glycopyrronium and ipratropium/salbutamol are approved for COPD treatment in the Netherlands

Conditions

COPD

Keywords

Nebulizer; DPI; COPD; indacaterol; ipratropium; glycopyrronium; salbutamol; Breezhaler; Nebuliser; Hyperinflation; Dyspnea; SABA; short-acting muscarinic antagonists (SAMA); long-acting beta2-agonist (LABA); LAMA; FEV1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

Participants start with Ultibro (indacaterol/glycopyrronium 110/50) + placebo nebulization , then after a new washout period of 7 days they will receive ipratropium/salbutamol nebulization and placebo Breezhaler Interventions: indacaterol/glycopyrronium 110/50 Breezhaler® ,Placebo by Breezhaler®, ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation, Placebo by nebulisation

Group Type: OTHER

indacaterol/glycopyrronium 110/50 Breezhaler®

Intervention Type: DRUG

Placebo by Breezhaler®

Intervention Type: DEVICE

ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation

Intervention Type: DRUG

Placebo by nebulisation

Intervention Type: DEVICE

B

Participants start with ipratropium/salbutamol nebulization and placebo Breezhaler , then after a new washout period of 7 days they will receive Ultibro(indacaterol/glycopyrronium 110/50) + placebo nebulization.

Interventions: indacaterol/glycopyrronium 110/50 Breezhaler® ,Placebo by Breezhaler®, ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation, Placebo by nebulisation

Group Type: OTHER

indacaterol/glycopyrronium 110/50 Breezhaler®

Intervention Type: DRUG

Placebo by Breezhaler®

Intervention Type: DEVICE

ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation

Intervention Type: DRUG

Placebo by nebulisation

Intervention Type: DEVICE

Interventions

indacaterol/glycopyrronium 110/50 Breezhaler®

Intervention Type: DRUG

Placebo by Breezhaler®

Intervention Type: DEVICE

ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation

Intervention Type: DRUG

Placebo by nebulisation

Intervention Type: DEVICE

Other Intervention Names

Ultibro; Combivent

Eligibility Criteria

Inclusion Criteria

1. COPD, post-bronchodilator FEV1/FVC < 70%; post-br FEV1 < 80%pred

2. Active mastery of Dutch

3. Written informed consent

4. At least 40 years old

5. Participants must be able to understand and complete protocol requirements, Instructions, and questionnaires provided in Dutch

Exclusion Criteria

1. Non invasive ventilation

2. Saturation by pulse oxymetry <88%

3. Documented history of asthma

4. Instable cardiac disease within 6 months.

5. Known long corrected QT interval (QTC) syndrome

6. Known estimated Glomerular Filtration Rate (EGFR) ( <30 ml/min *1,73m2

7. Exacerbations of COPD or change of medication for COPD in the last 6 weeks prior to inclusion

8. Allergic reaction or intolerance for a substance used in one of the products or atropine or atropine derived substances

9. Pregnant or lactating females.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

Wouter H. van Geffen

OTHER

Sponsor Role: lead

Responsible Party

Wouter H. van Geffen

Arts onderzoeker

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Huib AM Kerstjens, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Groningen Research Institute for Asthma and COPD

Wouter H van Geffen, MD

Role: STUDY_DIRECTOR

Frisius Medisch Centrum

Locations

UMCG

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

NL5250604215

Identifier Type: -

Identifier Source: org_study_id