NCT01741285

Brief Summary

We hypothesize that extra-fine particle treatment with HFA-QVAR will be superior in improving small airways dysfunction, especially in ex-smokers and smokers with asthma. To investigate this, we will perform a study comparing the efficacy of extra-fine particle HFA-QVAR 200 µg b.i.d. to an equipotent dose of course particle HFA-beclomethasone (HFA-Clenil) 400 µg b.i.d. and with coarse particle HFA-fluticasone (GSK) 250 µg in ex-smokers and smokers with asthma. Study design: This study will be an open-label, randomised, three-way cross-over, two-center study. 20 smokers and 20 ex-smokers with asthma will receive the following treatments for two weeks:

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Apr 2013

Typical duration for phase_4 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

November 27, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

2.2 years

First QC Date

November 27, 2012

Last Update Submit

August 25, 2016

Conditions

Asthma

Keywords

AsthmaAdenosineSmall airwaysSmokersEx-smokers

Outcome Measures

Primary Outcomes (1)

  • PD20 Adenosine

    The primary end-parameter is the PD20 small particle adenosine. The co-primary objective (only in case of non-inferiority of QVAR on the primary objective) will be: Reduction in peripheral airways resistance (R5-R20) measured with IOS at the provocative dose of small particle adenosine causing the FEV1 to drop with 20% (PD20).

    This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone

Secondary Outcomes (9)

  • Symptoms and Peakflow

    This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone

  • Airway resistance

    This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone

  • Spirometry

    This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone

  • Body Plethysmography

    This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone

  • Peripheral blood

    This measurement will be performed at baseline and after two weeks treatment with either QVAR, Clenil or Fluticasone

  • +4 more secondary outcomes

Study Arms (3)

Fluticasone

ACTIVE COMPARATOR

Two weeks treatment with HFA-Fluticasone 250 microgram twice daily

Drug: Beclomethasone (QVAR)Drug: Beclomethasone (Clenil)

Clenil

ACTIVE COMPARATOR

Two weeks treatment with HFA-Clenil 200 microgram 2 inhalations twice daily.

Drug: Beclomethasone (QVAR)Drug: Fluticasone

QVAR

EXPERIMENTAL

Two weeks treatment with QVAR 2 times 100 microgram twice daily

Drug: Beclomethasone (Clenil)Drug: Fluticasone

Interventions

Beclomethasone (QVAR)DRUG

Small particle treatment

Also known as: QVAR
ClenilFluticasone
Beclomethasone (Clenil)DRUG

Course particle beclomethasone

Also known as: Clenil
FluticasoneQVAR
FluticasoneDRUG

Course particle treatment

Also known as: Flixotide
ClenilQVAR

Eligibility Criteria

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

You may qualify if:

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • Males and females with a doctor's diagnosis of asthma
  • Age between 18 and 65 years
  • Current- and ex-smokers with ≥ 5 packyears.
  • Drop in FEV1 \> 20% after provocation with small particle adenosine \< 20 mg at visit 1.

You may not qualify if:

  • A subject who meets any of the following criteria will be excluded from participation in this study:
  • Severe airway obstruction at baseline, FEV1 \< 50% of predicted or \< 1.2 liter.
  • Physician diagnosed predominant COPD or any other pulmonary disease that could influence the study results as judged by the investigator.
  • Pregnant or lactating women.
  • Females of childbearing potential without an efficient contraception unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL or the use of one or more of the following acceptable methods of contraception:
  • Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
  • Hormonal contraception (implantable, patch, oral, injectable).
  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
  • Continuous abstinence. Periodic abstinence (e.g. calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

Related Publications (1)

  • Cox CA, Boudewijn IM, Vroegop SJ, Schokker S, Lexmond AJ, Frijlink HW, Hagedoorn P, Vonk JM, Farenhorst MP, Ten Hacken NHT, Kerstjens HAM, van den Berge M. Associations of AMP and adenosine induced dyspnea sensation to large and small airways dysfunction in asthma. BMC Pulm Med. 2019 Jan 28;19(1):23. doi: 10.1186/s12890-019-0783-0.

    PMID: 30691429DERIVED

MeSH Terms

Conditions

AsthmaSmoking Cessation

Interventions

BeclomethasoneFluticasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, ChlorinatedAndrostadienesAndrostenesAndrostanes

Study Officials

  • Maarten van den Berge, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chest Physician

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 4, 2012

Study Start

April 1, 2013

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

August 26, 2016

Record last verified: 2016-08

Locations

NL(1)