NCT00528723

Brief Summary

The purpose of this trial is to verify if the test treatment BDP 250 mcg/salbutamol 100 mcg HFA pMDI fixed combination is non-inferior to BDP 250 mcg/salbutamol 100 mcg pMDI fixed combination given with the conventional CFC propellant (Clenil® Compositum 250, Chiesi Farmaceutici) in terms of Pulmonary Function (morning PEF).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_3

Geographic Reach
4 countries

25 active sites

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

September 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

September 11, 2007

Last Update Submit

March 28, 2017

Conditions

Bronchial Asthma

Keywords

beclomethasoneas neededsalbutamolwheezing

Outcome Measures

Primary Outcomes (1)

  • Mean value of morning PEF (daily measured by the patient)

    last 2 weeks treatment

Secondary Outcomes (8)

  • Morning PEF daily measured by the patient at any other time point

    last 2 weeks treatment

  • Evening PEF, and morning and evening FEV1 daily measured by the patient

    all treatment period (12 weeks), at each two weeks

  • Pulmonary function parameters (FEV1, FVC, PEF and FEF25-75%)

    clinic visits

  • Changes from pre-dosing of pulmonary function parameters measured at in the interval 0-60 minutes (pre-dose and 5, 15, 30 and 60 minutes post-dose);

    baseline (visit 2) and end of treatment (visit 6)

  • Rates of asthma exacerbations (in total and by severity)

    all treatment period, at each two weeks

  • +3 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

BDP/salbutamol HFA pMDI

Drug: salbutamol 100 mcgDrug: BDP/salbutamol HFA pMDI

B

ACTIVE COMPARATOR

BDP/salbutamol CFC pMDI

Drug: salbutamol 100 mcgDrug: BDP/salbutamol CFC pMDI

Interventions

salbutamol 100 mcgDRUG

To be used as needed for symptom relief

Also known as: Ventolin®
AB
BDP/salbutamol HFA pMDIDRUG

Patients assigned to BDP/salbutamol HFA pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative CFC placebo

A
BDP/salbutamol CFC pMDIDRUG

Patients assigned to BDP/salbutamol CFC pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative HFA placebo

Also known as: Clenil® Compositum 250
B

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent obtained,
  • Male or female out-patients aged ³ 18 and \< 65 years;
  • Uncontrolled asthma defined according to the GINA 2006 "Classification of Levels of Asthma Control". This definition includes the presence of two or more of the following features (in addition to the required range of FEV1): a) daytime asthma symptoms \> twice a week; b) any limitation of activities; c) any nocturnal symptoms/awakening; b) need for reliever/rescue treatment \> twice a week. These conditions are to be based on recent medical history and are to be confirmed in the 2-week run-in period;
  • Forced expiratory volume in the first second (FEV1) ³ 60% and \< 80% of the predicted normal value;
  • Positive response to the reversibility test in the screening visit, defined as an increase of at least 12% (or, alternatively, of 200 mL) from pre-bronchodilator value in the measurement of FEV1 30 minutes following 4 puffs (4 ´ 100 µg) of inhaled salbutamol administered via pMDI. The reversibility test can be avoided in patients having a documented positive response in the previous 6 months;
  • Non-smokers or ex-smokers with a cumulative tobacco exposure less than 5 pack-years and who have stopped smoking since more than 1 year;
  • A co-operative attitude and ability to be trained to correctly use the pMDIs;

You may not qualify if:

  • Inability to carry out pulmonary function testing;
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD;
  • History of near fatal asthma;
  • Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks;
  • Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;
  • Patients who have been treated with an inhaled corticosteroid in the previous 4 weeks;
  • Patients who have been treated with nebulized, oral, intravenous or intramuscular corticosteroids in the past 8 weeks or depot injectable corticosteroids in the past 12 weeks;
  • Patients who have been treated with a long-acting β2-agonist (LABA) in the past 2 weeks;
  • Patients who have been treated with an oral β2-agonist in the past 48 hours;
  • Patients who have been treated with a short-acting β2-agonist (SABA) in the past 6 hours;
  • Patients who have been treated with nebulized bronchodilators in the past 2 weeks;
  • Patients who have been treated with anticholinergic medications (by any route) in the past 2 weeks;
  • Patients who have been treated with a xanthine derivative (by any route) in the past 4 weeks;
  • Patients who have been treated with an inhaled cromone or a leukotriene modifier in the past 4 weeks;
  • History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias;
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Servizio di Fisiopatologia Respiratoria Diagnostica Allergologica e Biologia Respiratoria Endoscopica e Toracica U.O.C. di Pneumologia Ospedale Orlandi

Bussolengo, (vr), 37012, Italy

Location

Unità Dipartimentale di Fisiopatologia Respiratoria -Dipartimento di Medicina Interna e Specialità Mediche (DI.MI.) - Ospedale S. Martino e Cliniche Universitarie Convenzionate

Genova, 16129, Italy

Location

Unità Operativa Complessa di Clinica fisiologica e Pneumologia - Dipartimento di Medicina Interna e Specialità Mediche (DI.MI.) - Ospedale S. Martino e Cliniche Universitarie Convenzionate

Genova, 16129, Italy

Location

Dipartimento di Medicina Ambientale e Sanità Pubblica-Sede di Medicina del Lavoro Servizio di Fisiopatologia Respiratoria

Padua, 35127, Italy

Location

Malattie dell'Apparato Respiratorio - Università degli Studi di Pisa Ospedale Cisanello

Pisa, 56100, Italy

Location

City Clinical Hospital № 61, Pulmonology Department

Moscow, 119048, Russia

Location

Central Clinical Hospital №1 OAO"RZD",Pulmonology Department

Moscow, 125315, Russia

Location

Clinical Hospital № 2, Pulmonology Department

Yaroslavl, 150010, Russia

Location

Clinical Hospital № 8, Pulmonology Department

Yaroslavl, 150030, Russia

Location

Regional Clinical Hospital, Department of Therapeutics of Post Graduate, Yaroslavl Medical Academy

Yaroslavl, 150062, Russia

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Department of Therapy of Kharkov Medical Academy of Postgraduate Education City Multifield Clinical Hospital n° 25

Kharkiv, 61008, Ukraine

Location

Pulmonological and Allergological Department of the Kharkov Regional Clinical Hospital

Kharkiv, 61022,, Ukraine

Location

Central Military Hospital of North Region. Pulmonological Department

Kharkiv, 61022, Ukraine

Location

Department of propaedeutics of internal diseases #1. Kharkov State Medical University.

Kharkiv, 61022, Ukraine

Location

Pulmonological Department # 2 City Clinical Hospital # 13

Kharkiv, 61035, Ukraine

Location

Pulmonological Department of the Institute of Therapy Ukrainian Academy of Medical Science

Kharkiv, 61035, Ukraine

Location

Department of General Practice - Family Medecine Medical Academy of post-graduate education. City Clinical Hospital N° 17

Kharkiv, 61037, Ukraine

Location

Department of Diagnostic, Therapy and Clinical Pharmacology of Lung Disease of the Institute of Phtisiology and Pulmonology Academy of Medical Sciences of the Ukraine

Kiev, 03680, Ukraine

Location

Institute of Phthisiology and Pulmonology Acedemy of Medical Science of the Ukraine

Kiev, 03680, Ukraine

Location

Pulmonology Department of the Institute of Phthisiology and Pulmonology AMS of the Ukraine

Kiev, 03680, Ukraine

Location

Department of Pediatrics and laboratory diagnostics, Dniepropetrovsk State Medical Academy City Clinical Hospital No. 8. Pulmonology Department. 55

Krivoi Rog, 50082, Ukraine

Location

General Therapy Clinic Central Military Clinical Hospital of Ministry of Defenses of Ukraine

Kyiv, 01133, Ukraine

Location

Department of Hospital Therapy of Lugansk State Medical Institute

Luhansk, 91045, Ukraine

Location

Department of Hospital Therapy, Lviv State Medical University named by Danylo Galytsky, Lviv Regional Clinical Hospital

Lviv, 79010, Ukraine

Location

Related Links

MeSH Terms

Conditions

AsthmaRespiratory Sounds

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Giovanni Cremonesi, M D

    Chiesi Farmaceutici S.p.A.

    STUDY DIRECTOR

  • Gabriele Nicolini, CPM

    Chiesi Farmaceutici S.p.A.

    STUDY DIRECTOR

  • Luis Puente, Dr

    Hospital General Universitario Gregorio Maranon, Madrid

    PRINCIPAL INVESTIGATOR

  • Giorgio Walter Canonica, Prof.

    Ospedale S.Martino e Cliniche Universitarie Convenzionate, Genova, Italy

    PRINCIPAL INVESTIGATOR

  • Igor Bereznyakov, Prof.

    Department of therapy of Kharkov Academy of Postgraduate Education, Kharkov, Ukraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

November 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

UA(14)ES(1)RU(5)IT(5)