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AsthmaPhase 2NCT02249312

The Effect of BIIL 284 BS on Induced-sputum Variables in Patients With Bronchial Asthma

A Phase 2 study testing BIIL 284 BS in people with Asthma, run by Boehringer Ingelheim.

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

Study to evaluate the anti-inflammatory effect of BIIL 284 BS compared with placebo in patients with asthma Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma
What is being tested?
BIIL 284 BS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
No sites listed yet
Study dates
Jul 1999to Apr 2000
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent signed and dated prior to participation into the study
  • Males and females aged 18 - 65 years. Female patients of child bearing potential cannot participate in this study. Female patients are eligible to participate only if they are surgically sterilized or two years post menopausal. Women entering into this trial will have a pregnancy test before and after participation in the trial. Testing will be done during visit 1 and visit 5
  • A documented diagnosis of asthma as defined by the American thoracic society i.e., episodic wheezing, chest tightness, cough and/or shortness of breath at least partially relieved by bronchodilator medication. No hospital admission in the last eight weeks for the treatment of asthma; no requirement for steroid therapy (systemic or inhaled) for the previous four weeks, nedocromil sodium or sodium cromoglycate in the previous two weeks; asthma therapy stable and limited to intermittent use of inhaled β2-agonists or anticholinergics on an as required basis, or occasional use of antihistamines. Predicted equations for forced expiratory volume in one second (FEV1) of Caucasians and African - Americans are those of Morris et. al. and Glindmeyer et. al. At visit 2, 3, and 5, immediately prior to the induced sputum test, but following albuterol administration, a patient's FEV1 must be above 60 % of predicted
  • The presence of, at least, 25 % of neutrophils in induced sputum during screening visit 2 (this requirement refers to the neutrophils percentage exclusive of squamous cells)
  • Ability to produce an adequate induced sputum sample (visit 2) as defined by: Volume > 1 ml, squamous cells < 80 % and ability to tolerate the procedure for at least 4 minutes with no bronchoconstriction (a fall in FEV1 > 20 %)
  • Patients with PC20 methacholine <= 8 mg/ml as determined at visit 1
Show all 18Show fewer
  • Non-smokers (patients who have never smoked) or ex-smokers for at least one year with a smoking history, no greater than five pack-years (1 pack year = 20 cigarettes per day for 1 year)
  • Ability to be trained in the proper use of peak flow meter (Mini Wright peak flow meter, Clement Clarke, Inc.) and in performing and recording technically satisfactory pulmonary function tests
  • Willing to attend an outpatient clinic on a regular basis and undergo three induced sputum challenges during which they will be confined to the investigational unit for up to two hours
  • Ability to comply with the concomitant therapy restrictions
  • Patients will be off all prescription drug therapy other than that specifically for asthma or hay fever. Over the counter (O.T.C.) drugs must be discontinued for at least two weeks prior to participation in the study. If any O.T.C. medication is needed by patients throughout the study, the investigator will call the clinical monitor and this will be reviewed on a case-by-case basis
  • Patients will have no evidence of clinically relevant concomitant disease based upon complete medical history, full physical examination, chest x-ray (if not done in previous 6 months), electrocardiogram (ECG) and clinical laboratory tests. These tests should indicate that the patient is healthy except for changes related to asthma or atopy (e.g., eosinophilia based on a total eosinophil count). Patient may have a history of allergic rhinitis or urticaria.
  • The following laboratory parameters must be within the normal range, or if not, be documented by the investigator as not clinically relevant:
  • Routine urinalysis, Complete blood cell (CBC) (excluding White blood cell (WBC)) , Na, K, Ca, Cl, Gamma-glutamyl-transferase (GGT), Lactic dehydrogenase (LDH), bicarbonate, inorganic phosphorus, glucose, uric acid, triglyceride, total protein, albumin and cholesterol.
  • The following test may be outside the normal range to the extent indication:
  • Test a; Liver function tests: serum glutamic oxaloacetic transaminase / aspartate aminotransferase (SGOT/AST), serum glutamic pyruvic transaminase / alanine transaminase (SGPT/ALT), total bilirubin (in patients with an isolated raised bilirubin and diagnosis of " suspected Gilbert's syndrome" will be accepted only after the effect of high carbohydrate meal or bilirubin level has been determined) and alkaline phosphatase with a cut off for exclusion by 10 % > ULN (upper limit of normal range for the measuring laboratory)
  • Test b; Hematology: WBC with a cut off for exclusion by < 3.80 x 109 /L, neutrophils with a cut off for exclusion by < 2.00 x 109 /L, platelets with a cut off for exclusion by < 100 x 10**9 /L, hemoglobin with a cut off for exclusion by < 12 g/dL
  • Test c; urea nitrogen and creatinine with a cut off for exclusion by 10 % > ULN

Who cannot join

  • Viral respiratory tract infection, respiratory tract infection or asthma exacerbation within the six weeks preceding the study or, if hospitalized for their asthma in the last eight weeks
  • Evidence of relevant concomitant disease based on complete medical history, full physical examination and clinical laboratory tests
  • Known drug or alcohol dependence (absence of dependency for 10 years), history of significant allergic reactions to drugs or sensitivity to aspirin
  • Use of an investigational new drug in the preceding month or six half lives (whichever is greater) prior to the first screen at visit 1
  • Donate of blood during the preceding month of visit 1
  • Patients receiving hyposensitization therapy who are not on a stable dose for the last three months before visit 1

About this study

Official title: The Effect of BIIL 284 BS (14 Day Treatment) on Induced-sputum Variables in Patients With Bronchial Asthma (a Double-blind, Randomized, Placebo-controlled Parallel Study)

Study to evaluate the anti-inflammatory effect of BIIL 284 BS compared with placebo in patients with asthma

Conditions
Asthma
Being tested
BIIL 284 BS, Placebo
Medical subject headings
Asthma

What participants receive

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

  • BIIL 284 BSDrug

  • PlaceboDrug

Study groups in NCT02249312
Study groupRoleWhat they receive
BIIILExperimentalNot described
Receives: Drug: BIIL 284 BS
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of neutrophils in induced sputum differential cell count

    Measured: Baseline, Day 1 and 14

Secondary outcomes (16)

  1. Concentration of myeloperoxidase (MPO) in induced sputum

    Measured: Baseline, Day 1 and 14

  2. Concentration of Interleukin-8 (IL-8) in induced sputum

    Measured: Baseline, Day 1 and 14

  3. Concentration of tumor necrosis factor (TNF) alpha in induced sputum

    Measured: Baseline, Day 1 and 14

  4. Differential cell count in induced sputum

    eosinophils, basophils, macrophages, lymphocytes and epithelia cells

    Measured: Baseline, Day 1 and 14

  5. Changes in expression of Epidermal growth Factor (EGF) receptors in induced sputum

    only in US center

    Measured: Day 1 and 14

  6. Changes in expression of tissue growth factor (TGF) alpha in induced sputum

    only in US center

    Measured: Day 1 and 14

  7. Changes in expression of MUC5AC (maximum use concentration) in induced sputum

    only in US center

    Measured: Day 1 and 14

  8. Changes in forced expiratory volume in one second (FEV1)

    assessed by spirometry

    Measured: Up to Day 27 after drug administration

  9. Changes in forced vital capacity (FVC)

    assessed by spirometry

    Measured: Up to Day 27 after drug administration

  10. Changes in forced expiratory flow (FEF) 25-70%

    assessed by spirometry

    Measured: Up to Day 27 after drug administration

  11. Changes in FEF50%

    assessed by spirometry

    Measured: Up to Day 27 after drug administration

  12. Changes in FEF 75%

    assessed by spirometry

    Measured: Up to Day 27 after drug administration

  13. Changes in peak expiratory flow rate (PEFR) a.m. versus p.m.by patients daily records

    Measured: Up to Day 27 after drug administration

  14. Physician's global evaluation of symptoms assessed on a 6 point severity scale

    Measured: Baseline, Day 14

  15. Inhibition of MAC-1 expression

    Measured: Day 1 and 14

  16. Number of patients with Adverse Events

    Measured: Up to day 27 after drug administration

Timeline

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

  1. First posted25 Sep 2014 (estimated)
  2. Study startJul 1999
  3. Primary completionApr 2000

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02249312
Sponsor's protocol ID
543.11
Status last verified
Sep 2014
First submitted
23 Sep 2014
Last updated
26 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIIL 284 BS in people with Asthma, run by Boehringer Ingelheim.

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 18 inclusion and 6 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 26 Sep 2014. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Percentage of neutrophils in induced sputum differential cell count (time frame: Baseline, Day 1 and 14). 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 NCT02249312.

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 26 Sep 2014.

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