We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Single Dose Ultibro Breezhaler by Sd-DPI Versus Ipratropium/Salbutamol by Nebulizer in COPD (ULT01)

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: NCT02576626
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : October 11, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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


Condition or disease Intervention/treatment Phase
COPD Drug: indacaterol/glycopyrronium 110/50 Breezhaler® Device: Placebo by Breezhaler® Drug: ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation Device: Placebo by nebulisation Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Single Dose Ultibro Breezhaler (Indacaterol/Glycopyrronium) by Sd-DPI Versus Ipratropium/Salbutamol by Nebulizer in Improving FEV1 and Dyspnea During Stable State of COPD
Study Start Date : December 2015
Primary Completion Date : September 29, 2017
Study Completion Date : September 29, 2017


Arms and Interventions

Arm Intervention/treatment
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
Drug: indacaterol/glycopyrronium 110/50 Breezhaler®
Other Name: Ultibro
Device: Placebo by Breezhaler® Drug: ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation
Other Name: Combivent
Device: Placebo by nebulisation
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

Drug: indacaterol/glycopyrronium 110/50 Breezhaler®
Other Name: Ultibro
Device: Placebo by Breezhaler® Drug: ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation
Other Name: Combivent
Device: Placebo by nebulisation


Outcome Measures

Primary Outcome Measures :
  1. Area under the curve (AUC) of FEV1 [ Time Frame: from 0 to 6 hours ]
    Area under the curve (AUC) from 0 to 6 hours of FEV1 with indacaterol and glycopyrronium, compared to nebulisation with ipratropium/salbutamol.


Secondary Outcome Measures :
  1. Change in Borg dyspnea score at 30 min [ Time Frame: 30 min up to 360 minutes ]
    1. Change in Borg dyspnea score at 30 min: change in Borg score at other time points

  2. Proportion of patients reaching the minimal clinically important difference (MCID) at all time points [ Time Frame: all time points (15, 30, 60, 120 240 and 360 min) ]
    proportion of patients reaching the MCID at all time points (15, 30, 60, 120 240 and 360 min) (1)

  3. Changes in level of hyperinflation (by IC measurement) [ Time Frame: all time points (15, 30, 60, 120 240 and 360 min) ]
  4. Time to FEV1 increase of 100 ml [ Time Frame: all time points (15, 30, 60, 120 240 and 360 min) ]
  5. Peak effect of FEV1 [ Time Frame: from 0 to 6 hours ]
    Maximum FEV1 per group, calculated using the best FEV1 per participant

  6. Time to peak of FEV1 [ Time Frame: all time points (15, 30, 60, 120 240 and 360 min) ]
  7. FEV1 [ Time Frame: at all time points (15, 30, 60, 120 240 and 360 min) ]
  8. Proportion of participants reaching a difference of 100 ml of inspiratory capacity (IC) [ Time Frame: Time Frame: all time points (15, 30, 60, 120 240 and 360 min) ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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): NCT02576626


Locations
Netherlands
UMCG
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
Wouter H. van Geffen
Novartis
University Medical Center Groningen
Investigators
Principal Investigator: Huib AM Kerstjens, prof. dr. Groningen Research Institute for Asthma and COPD
Study Director: Wouter H van Geffen, MD Medical Centre Leeuwarden
More Information

Responsible Party: Wouter H. van Geffen, Arts onderzoeker, Groningen Institute for Asthma and COPD
ClinicalTrials.gov Identifier: NCT02576626     History of Changes
Other Study ID Numbers: NL5250604215
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by Wouter H. van Geffen, Groningen Institute for Asthma and COPD:
Nebulizer
DPI
COPD
indacaterol
ipratropium
glycopyrronium
salbutamol
Breezhaler
Nebuliser
Hyperinflation
Dyspnea
SABA
short-acting muscarinic antagonists (SAMA)
long-acting beta2-agonist (LABA)
LAMA
FEV1

Additional relevant MeSH terms:
Albuterol
Ipratropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents