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AsthmaPhase 3NCT00273520

TELICAST : Telithromycin in Acute Exacerbations of Asthma

A Phase 3 study testing Telithromycin in people with Asthma, run by Sanofi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: The primary objective is to evaluate the clinical efficacy of telithromycin versus placebo as a supplement to the usual standard of care during an acute exacerbation of asthma. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Asthma
What is being tested?
Telithromycin
How many people
Not given
Where
No sites listed yet
Study dates
Jan 2003to May 2004
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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients meeting all of the following criteria will be considered for enrollment in the study:
  • A documented history of asthma for >6 months
  • Presenting within 24 hours of initial medical care in an urgent care clinic, emergency room, or in-patient hospital setting. To qualify for enrollment they must present with the following signs and symptoms of an acute deterioration in asthma control: (reduced PEFR, increased wheeze, and dyspnea, with or without cough).
  • A PEFR less than 80% of predicted normal
  • Females who meet the following conditions:
  • postmenopausal for at least 1 year, or
Show all 11Show fewer
  • surgically incapable of bearing children, or
  • of childbearing potential, and all of the following conditions are met:
  • had a normal menstrual flow within 1 month before study entry and
  • has a negative pregnancy test (serum b-subunit human chorionic gonadotropin [hCG]) immediately before study entry and
  • must agree to abstinence or use of an accepted method of contraception

Who cannot join

  • Patients presenting with any of the following will not be included in the study:
  • Requiring immediate placement in an Intensive Care Unit
  • Obvious known allergic precipitant for this episode of acute severe asthma (e.g., acute exposure to animal dander)
  • Pneumonia
  • Known long QT syndrome or familial history of long QT syndrome (if no previous electrocardiogram [ECG] has invalidated this risk factor), or personal history of coronary disease, ventricular arrhythmia, bradycardia <50 beats/min, or known uncorrected hypokalemia or magnesemia
  • Known impaired hepatic or renal function
Show all 27Show fewer
  • Known diagnosis of myasthenia gravis
  • Active or quiescent tuberculosis infections of the respiratory tract
  • Acute exacerbation of chronic bronchitis, chronic obstructive pulmonary disease, cystic fibrosis, or emphysema
  • A history of smoking of 10 pack-years or more
  • Women who are breast feeding or are pregnant, as demonstrated by serum or urine pregnancy tests
  • Suspected or known hypersensitivity to, or suspected serious adverse reaction to the macrolide class of antibiotics
  • A concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) that would make implementation of the protocol or interpretation of the study results difficult
  • A recent (within the previous 3 months) history of alcohol or recreational drug misuse.
  • Immunocompromised patients, including but not limited to:
  • patients with known human immunodeficiency virus (HIV) infection and have either had or have an AIDS defining condition (e.g., Kaposi's sarcoma, Pneumocystis carinii pneumonia) or a CD4 + T lymphocyte count of <200/mL
  • patients with neutropenia (<1500 neutrophils/mm3)
  • patients with metastatic or hematological malignancy
  • splenectomized patients or patients with known hyposplenia or asplenia
  • Planned surgical treatment at any time during the course of the study that would be incompatible with the objectives of this study
  • Other disease conditions or infections that could interfere with the evaluation of study treatment efficacy or safety
  • Oral steroid-dependent asthma
  • Antibiotic use within 30 days prior to enrollment
  • Treated within 2 weeks prior to inclusion with CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, and St. John's Wart
  • Currently receiving medication known to prolong QT interval such as cisapride, pimozide, astemizole and terfenadine, or potent CYP3A4 inhibitors such as antiproteases or ketoconazole.
  • Patients in whom an antibiotic is clearly indicated.
  • Have received treatment with any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period during treatment and follow-up phase

About this study

Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Telithromycin 800 mg (Once Daily for 10 Days) as a Supplement to the Standard of Care for Patients With Acute Exacerbations of Asthma

Primary Objective:

  • The primary objective is to evaluate the clinical efficacy of telithromycin versus placebo as a supplement to the usual standard of care during an acute exacerbation of asthma. Efficacy will be assessed by:
  • Changes in the diary card summary symptom score assessed daily for 6 weeks, and
  • Changes in the domiciliary morning Peak Expiratory Flow Rate (PEFR) following oral telithromycin treatment
Read more

Secondary Objectives:

The secondary objectives of the study are:

  • To evaluate the microbial activity of telithromycin during an exacerbation of asthma by:
  • Assessment of the patient's clinical improvement relative to initial C. pneumoniae or M. pneumoniae status, and
  • Analysis of the quantitative changes from baseline in C. pneumonia or M. pneumoniae by culture and quantitative Polymerase Chain Reaction (PCR).
  • To evaluate the safety of 10 days of oral telithromycin as a supplement to the standard of care for patients with acute exacerbations of asthma
  • To assess additional efficacy endpoints and health outcome evaluations following 10 days of treatment with either oral telithromycin or placebo, with either treatment used as a supplement to the standard of care for patients with acute exacerbations of asthma:
  • Changes and daily variability in the PEFR during the 6 weeks of study treatment,
  • Health status at follow-up (6 weeks)
  • Pulmonary function tests:
  • Forced Expiratory Volume in 1 second (FEV1)
  • Forced Vital Capacity (FVC)
  • Forced Expiratory Flow Rate (FEF25-75%)
  • Need for additional medications (e.g., inhaled corticosteroids, oral corticosteroids, bronchodilator use),
  • Time to next acute exacerbation of asthma.
Conditions
Asthma
Being tested
Telithromycin
Medical subject headings
Asthma

What participants receive

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

  • TelithromycinDrug

What is being measured

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

  1. Patient's daily diary summary symptom scores/Morning diary PEFR

    Measured: During the Study Conduct

Secondary outcomes (3)

  1. In-clinic pulmonary function tests: Forced expiratory volume in 1 second (FEV1), Percent predicted FEV1, Forced vital capacity (FVC), Forced expiratory flow rate at 25% to 75% of FVC (FEF25-75), PEFR, and percent predicted PEFR

    Measured: During the study conduct

  2. Evening diary PEFR, and diary PEFR variability

    Measured: During the study conduct

  3. Time to symptom resolution from study entry acute exacerbation of asthma

    Measured: During the study conduct

Timeline

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

  1. First posted9 Jan 2006 (estimated)
  2. Study startJan 2003
  3. Primary completionApr 2004
  4. Study completionMay 2004

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
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00273520
Sponsor's protocol ID
HMR3647A_3503
Status last verified
Sep 2009
First submitted
6 Jan 2006
Last updated
15 Sep 2009
Results posted
No
Data monitoring committee
No

Publications

  • Johnston SL, Blasi F, Black PN, Martin RJ, Farrell DJ, Nieman RB; TELICAST Investigators. The effect of telithromycin in acute exacerbations of asthma. N Engl J Med. 2006 Apr 13;354(15):1589-600. doi: 10.1056/NEJMoa044080.

    PubMed 16611950

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telithromycin in people with Asthma, run by Sanofi.

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 11 inclusion and 27 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: finished, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Patient's daily diary summary symptom scores/Morning diary PEFR (time frame: During the Study Conduct). 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 NCT00273520, which also lists 1 linked publication.

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 15 Sep 2009.

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