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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:
Novartis
University Medical Center Groningen
Information provided by (Responsible Party):
Wouter H. van Geffen, Groningen Research Institute for Asthma and COPD

Tracking Information
First Submitted Date  ICMJE August 4, 2015
First Posted Date  ICMJE October 15, 2015
Last Update Posted Date October 11, 2017
Study Start Date  ICMJE December 2015
Actual Primary Completion Date September 29, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2015)
  • 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
  • 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)
  • Changes in level of hyperinflation (by IC measurement) [ Time Frame: all time points (15, 30, 60, 120 240 and 360 min) ]
  • Time to FEV1 increase of 100 ml [ Time Frame: all time points (15, 30, 60, 120 240 and 360 min) ]
  • Peak effect of FEV1 [ Time Frame: from 0 to 6 hours ]
    Maximum FEV1 per group, calculated using the best FEV1 per participant
  • Time to peak of FEV1 [ Time Frame: all time points (15, 30, 60, 120 240 and 360 min) ]
  • FEV1 [ Time Frame: at all time points (15, 30, 60, 120 240 and 360 min) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
  • 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
  • Proportion of patients reaching the 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)
  • Changes in level of hyperinflation (by IC measurement) [ Time Frame: all time points (15, 30, 60, 120 240 and 360 min) ]
  • Time to FEV1 increase of 100 ml [ Time Frame: all time points (15, 30, 60, 120 240 and 360 min) ]
  • Peak effect of FEV1 [ Time Frame: from 0 to 6 hours ]
    Maximum FEV1 per group, calculated using the best FEV1 per participant
  • Time to peak of FEV1 [ Time Frame: all time points (15, 30, 60, 120 240 and 360 min) ]
  • FEV1 [ Time Frame: at all time points (15, 30, 60, 120 240 and 360 min) ]
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Dose Ultibro Breezhaler by Sd-DPI Versus Ipratropium/Salbutamol by Nebulizer in COPD
Official Title  ICMJE 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
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COPD
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • 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
  • 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

    Interventions:
    • 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
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 Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 29, 2017
Actual Primary Completion Date September 29, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02576626
Other Study ID Numbers  ICMJE NL5250604215
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wouter H. van Geffen, Groningen Research Institute for Asthma and COPD
Study Sponsor  ICMJE Wouter H. van Geffen
Collaborators  ICMJE
  • Novartis
  • University Medical Center Groningen
Investigators  ICMJE
Principal Investigator: Huib AM Kerstjens, prof. dr. Groningen Research Institute for Asthma and COPD
Study Director: Wouter H van Geffen, MD Medical Centre Leeuwarden
PRS Account Groningen Research Institute for Asthma and COPD
Verification Date October 2017

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