NCT00896428

Brief Summary

Severe asthma is a difficult to treat disease, characterized by bronchial remodelling, which is an abnormal repair process that contributes to the development of poorly reversible airway narrowing. Such remodelling is now considered as one of the main prognostic factors. Gallopamil-sensitive calcium influx plays a key role in this remodelling process in vitro. The objective of this study is to compare the effects of gallopamil versus placebo on the bronchial smooth muscle remodelling in severe asthmatic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2 asthma

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

2.6 years

First QC Date

May 7, 2009

Last Update Submit

August 13, 2013

Conditions

Asthma

Keywords

Asthmagallopamilairway remodellingsmooth muscle

Outcome Measures

Primary Outcomes (1)

  • Bronchial smooth muscle remodelling assessed by optic microscopy.

    Before and after 12 months treatment.

Secondary Outcomes (4)

  • Bronchial smooth muscle remodelling assessed by electron microscopy

    Before and after 12 months treatment.

  • Bronchial smooth muscle mitochondrial number and activity assessed in vitro

    Before and after 12 months treatment.

  • Bronchial thickness assessed by 3D analysis of computed tomography

    Before and after 12 months treatment.

  • Asthma control using asthma control questionnaire, inflammation monitoring, number of hospitalizations, number of emergency visits, number of unplanned medical visits.

    Once per month for 12 months.

Study Arms (2)

1

EXPERIMENTAL

16 patients with a diagnosis of severe asthma under gallopamil treatment

Drug: Methoxyverapamil (gallopamil)

2

PLACEBO COMPARATOR

16 patients with a diagnosis of severe asthma under placebo treatment

Drug: Placebo.

Interventions

Methoxyverapamil (gallopamil)DRUG

200 mg/day (1 tablet 100 mg morning and evening) for 12 months.

1
Placebo.DRUG

1 tablet morning and evening for 12 months

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged more than 18 years
  • Written informed consent
  • Diagnosis of severe asthma according to ATS criteria

You may not qualify if:

  • Smoker or former smoker
  • Chronic viral infections (hepatitis, HIV)
  • Aspergillosis
  • Pregnancy
  • Breastfeeding
  • Contraindications to gallopamil or bronchoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Haut-Lévêque - Centre Hospitalier Universitaire de Bordeaux

Pessac, 33604, France

Location

Related Publications (2)

  • Trian T, Benard G, Begueret H, Rossignol R, Girodet PO, Ghosh D, Ousova O, Vernejoux JM, Marthan R, Tunon-de-Lara JM, Berger P. Bronchial smooth muscle remodeling involves calcium-dependent enhanced mitochondrial biogenesis in asthma. J Exp Med. 2007 Dec 24;204(13):3173-81. doi: 10.1084/jem.20070956. Epub 2007 Dec 3.

    PMID: 18056286BACKGROUND

  • Girodet PO, Dournes G, Thumerel M, Begueret H, Dos Santos P, Ozier A, Dupin I, Trian T, Montaudon M, Laurent F, Marthan R, Berger P. Calcium channel blocker reduces airway remodeling in severe asthma. A proof-of-concept study. Am J Respir Crit Care Med. 2015 Apr 15;191(8):876-83. doi: 10.1164/rccm.201410-1874OC.

    PMID: 25633090DERIVED

MeSH Terms

Conditions

AsthmaAirway Remodeling

Interventions

Gallopamil

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

VerapamilPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Patrick Berger, Professor

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 11, 2009

Study Start

December 1, 2009

Primary Completion

July 1, 2012

Study Completion

November 1, 2012

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations

FR(1)