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Chronic Obstructive Pulmonary DiseasePhase 3FAIRNCT01351792

A Study in Patients With Chronic Obstructive Pulmonary Disease (FAIR)

A Phase 3 study testing Foster® 100/6 µg/unit dose and Symbicort® Turbohaler® 200/6 μg/actuation in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the present study is to demonstrate the higher efficacy of small particles Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations b.i.d.), in terms of residual volume reduction over a 12-week treatment period in Chronic Obstructive Pulmonary Disease (COPD) patients. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Foster® 100/6 µg/unit dose and Symbicort® Turbohaler® 200/6 μg/actuation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
1 siteNetherlands
Study dates
Sep 2011to Nov 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or when applicable written informed consent obtained by legal representative.
  • Outpatients with a clinical diagnosis of moderate to severe COPD and including:
  • Smoking history of at least 10 pack years defined as [(number of cigarettes smoked per day) x (number of years of smoking)] / 20, both current and ex-smokers are eligible.
  • Regular use of bronchodilators (e.g. β2-agonist, anticholinergics) in the 2 months before visit 1.
  • Post-bronchodilator FEV1 < 65% of the predicted normal value at visit 1.
  • Post-bronchodilator FEV1/FVC < 0.7 at visit 1.
Show all 17Show fewer
  • An increase in FEV1 < 15% and < 200 mL from baseline following administration of 400 µg of salbutamol at visit 1.
  • Plethysmographic Functional Residual Capacity (FRC) > 120% of the predicted normal value (at visit 1 and visit 2).
  • A Baseline Dyspnoea Index (BDI) focal score less or equal to 10 (at visit 1 and at visit 2).
  • A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Turbohaler®, inspiratory flow-driven, multidose powder inhaler) inhalers.
  • Main Exclusion Criteria:
  • Diagnosis of asthma or other clinically or functionally relevant respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator's opinion.
  • Clinically unstable concurrent disease: e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. coronary artery disease, hypertension, heart failure); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other which may impact the evaluation of the results of the study according to investigator's judgement.
  • Patients with COPD exacerbation and/or symptomatic infection of the airways requiring antibiotic therapy (at least 5 days) in the 2 months prior to screening and during the study period.
  • Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period.
  • Major surgery in the previous 3 months and during the trial which may affect patient's compliance in study procedures (e.g. plethysmography).
  • Patients requiring chronic mechanical ventilation for COPD.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Department of Pulmonary Diseases - University Medical Center Groningen

    Groningen, 9713

Other trials in Netherlands

About this study

Official title: A 12-week, Multicentre, Randomised, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® 100/6 (Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg/Actuation), 2 Puffs b.i.d., Versus Symbicort® 200/6 (Budesonide 200 µg Plus Formoterol 6 µg/Actuation), 2 Inhalations b.i.d., on Parameters of Small Airway Function in Patients With Chronic Obstructive Pulmonary Disease.

The purpose of the present study is to demonstrate the higher efficacy of small particles Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations b.i.d.), in terms of residual volume reduction over a 12-week treatment period in Chronic Obstructive Pulmonary Disease (COPD) patients.

Read the detailed description

Chronic obstructive pulmonary disease (COPD) is an incurable, debilitating and progressive disease that can be fatal. The recent Global Burden of Disease Study ranks COPD as the 6th leading cause of mortality and the 12th leading cause of morbidity world-wide. Furthermore, trends in the use of medical care resources indicate that the economic cost of COPD continues to rise in direct relation to the ageing population, the increase in prevalence of disease and the cost of new and existing medical and public health interventions.

Being tested
Foster® 100/6 µg/unit dose, Symbicort® Turbohaler® 200/6 μg/actuation
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foster® 100/6 µg/unit doseDrug

    Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations b.i.d. (daily dose of BDP "extrafine" 400 µg plus FF 24 µg).

  • Symbicort® Turbohaler® 200/6 μg/actuationDrug

    Symbicort® Turbohaler® (budesonide 200 μg plus formoterol fumarate 6 μg/actuation), 2 inhalations b.i.d. (daily dose of BUD 800 μg plus FF 24 μg).

Study groups in NCT01351792
Study groupRoleWhat they receive
Foster®ExperimentalFoster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations b.i.d. (daily dose of BDP "extrafine" 400 µg plus FF 24 µg).
Receives: Drug: Foster® 100/6 µg/unit dose
Symbicort® Turbohaler®Active comparatorSymbicort® Turbohaler® (budesonide 200 μg plus formoterol fumarate 6 μg/actuation), 2 inhalations b.i.d. (daily dose of BUD 800 μg plus FF 24 μg).
Receives: Drug: Symbicort® Turbohaler® 200/6 μg/actuation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to end of treatment in post-dose residual volume.

    Measured: At day 84

Secondary outcomes (11)

  1. Changes from baseline in FEV1, FVC, FEV1/FVC, IVC/FVC, RV, TLC, RV/TLC, FRC, FRC/TLC, RV/VC, Raw, eff and sGaw, eff.

    Measured: At day 84

  2. Changes from baseline in airways resistance (R5, R20, R5-20) and reactance at 5 Hertz (X5) (in a subset of at least 50% of patients from pre-selected sites);

    Measured: at day 84

  3. Changes from baseline in COPD symptom scores (for each single score and the total score);

    Measured: At day 84

  4. Change from baseline in percentage of COPD symptom-free days;

    Measured: At day 84

  5. Change from baseline in rescue salbutamol or ipratropium bromide consumption (puffs per day);

    Measured: At day 84

  6. Change from baseline in percentage of rescue salbutamol or ipratropium bromide-free days;

    Measured: At day 84

  7. Transition Dyspnoea Index (TDI) score;

    Measured: At day 84 (V4)

  8. Clinical COPD Questionnaire (CCQ);

    Measured: At screening (day -28), at baseline (day 0) and at the end of trial (day 84)

  9. Physical activity (by means of pedometer);

    Measured: Each day of the two weeks before each clinic visit

  10. Nasal brushing (mRNA expression);

    Measured: At screening (day -28), at baseline (day 0) and at the end of trial (day 84)

  11. Number of patients with COPD exacerbations.

    Measured: From pre-screening (day -35) to the end of trial (day 84)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01351792
Sponsor's protocol ID
CCD-1007-PR-0045
Other IDs
2010-022895-30
Acronym
FAIR
Status last verified
Mar 2017
First submitted
10 May 2011
Last updated
30 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Faiz A, Imkamp K, van der Wiel E, Boudewijn IM, Koppelman GH, Brandsma CA, Kerstjens HAM, Timens W, Vroegop S, Pasma HR, Boersma WG, Wielders P, van den Elshout F, Mansour K, Steiling K, Spira A, Lenburg ME, Heijink IH, Postma DS, van den Berge M. Identifying a nasal gene expression signature associated with hyperinflation and treatment response in severe COPD. Sci Rep. 2020 Oct 15;10(1):17415. doi: 10.1038/s41598-020-72551-0.

    PubMed 33060632

  • Boudewijn IM, Faiz A, Steiling K, van der Wiel E, Telenga ED, Hoonhorst SJM, Ten Hacken NHT, Brandsma CA, Kerstjens HAM, Timens W, Heijink IH, Jonker MR, de Bruin HG, Sebastiaan Vroegop J, Pasma HR, Boersma WG, Wielders P, van den Elshout F, Mansour K, Spira A, Lenburg ME, Guryev V, Postma DS, van den Berge M. Nasal gene expression differentiates COPD from controls and overlaps bronchial gene expression. Respir Res. 2017 Dec 21;18(1):213. doi: 10.1186/s12931-017-0696-5.

    PubMed 29268739

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Foster® 100/6 µg/unit dose and Symbicort® Turbohaler® 200/6 μg/actuation in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to end of treatment in post-dose residual volume. (time frame: At day 84). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01351792, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.

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