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Atopic AsthmaPhase 2NCT01890161

A Phase IIa Repeat Dose AXP1275 vs Placebo Cross-over Trial With Pulmonary Allergen Challenge in Adults With Asthma

A Phase 2 study testing AXP1275 in people with Atopic Asthma, run by Axikin Pharmaceuticals, Inc. at 3 sites in Canada.

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

This is the first study in human patients with asthma that the sponsor is conducting in order to evaluate if there are signals that the investigational medication, AXP1275, may be a safe and effective treatment for asthma. The results of this study may help the sponsor to design additional studies. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Atopic Asthma
What is being tested?
AXP1275
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
3 sitesCanada
Study dates
Aug 2013to Apr 2014
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 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 18 to 64 years (inclusive).
  • Male or female.
  • If male, is surgically sterile (vasectomy) or agrees to comply with required contraceptive measures.
  • If female, not pregnant (or lactating), as evidenced by a negative serum pregnancy test, and is either surgically sterile (hysterectomy, bilateral ovariectomy, or bilateral tubal ligation), or if a female of childbearing potential, agrees to comply with required contraceptive measures.
  • History of episodic wheeze and shortness of breath with a prebronchodilator FEV1 ≥70% of predicted at screening.
  • Asthma symptoms treated (if necessary) only with intermittent short-acting ß-agonist therapy by inhalation.
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  • Demonstration of a positive wheal reaction on skin prick testing to at least 1 common aeroallergen at screening.
  • Screening inhalational allergen challenge response demonstrating that the subject experiences both an early asthmatic response (EAR) and a late asthmatic response (LAR).
  • Methacholine PC20 ≤16 mg/mL at screening.
  • No history of smoking within 6 months of screening, and with a total pack year history of ≤10 pack years.
  • 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the investigator.
  • All values for hematology, clinical chemistry, and urinalysis within the normal range, or if abnormal, are deemed not clinically significant by the investigator with documented agreement from the medical monitor.
  • Is able to give written informed consent.

Who cannot join

  • Past or present disease which, as judged by the investigator, may affect the outcome of this study.
  • Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the screening period.
  • Symptomatic allergic rhinitis. Those subjects with a history of allergic rhinitis may participate if asymptomatic at screening (and continue to be so at baseline on Day 1 prior to dosing) and if, in the opinion of the investigator, it is unlikely that disease exacerbation will occur during the course of the study.
  • History of life-threatening asthma.
  • Abnormal chest X-ray.
  • Use of oral, injectable, or dermal steroids within 3 months and/or inhaled steroids within 1 month of screening.
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  • Use of cromoglycate, nedocromil, leukotriene receptor antagonists (zafirlukast, pranlukast, montelukast), and inhibitors of 5-lipoxygenase (zileuton) within 4 weeks of screening.
  • Use of immunosuppressives, anticoagulants (warfarin or heparin), or any medications that may interact with pharmacodynamic (PD) effects of AXP1275 within 4 weeks of screening.
  • Use of theophylline-containing agents (any type) and long-acting β2-agonists (salmeterol, formoterol) within 4 weeks of screening.
  • Positive screen for drug(s) of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, or benzodiazepines) or cotinine.
  • Positive for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV) 1/2.
  • Has participated in a clinical trial and has received an investigational product within 30 days prior to screening, or 5 elimination half lives of the investigational product, whichever is longer.
  • Has had significant blood loss (>500 mL) or donation of blood within 2 months prior to screening visit 1.
  • History of being unable to tolerate or complete methacholine or allergen challenge tests.
  • Subject is undergoing allergen desensitization therapy.
  • History of immunotherapy in the 3 years prior to screening or concurrently undergoing immunotherapy treatment.
  • Professional or ancillary personnel involved in the study.
  • Is not, in the opinion of the investigator, suitable for entry into the study.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • McMaster University

    Hamilton, Ontario, L8S 4K1

  • IUCPQ, Institut de cardiologie et de pneumologie de l'Hôpital Laval

    Québec, Quebec, G1V 4G5

  • Vancouver General Hospital, The Lung Centre

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Official title: A Phase IIa Randomized Double-blind Placebo-controlled Two-way Cross-over Trial of the Effects of Repeat Doses of 50 mg AXP1275 Daily on the Asthmatic Response to a Pulmonary Allergen Challenge in Adults With Mild-to-Moderate Atopic Asthma

This is the first study in human patients with asthma that the sponsor is conducting in order to evaluate if there are signals that the investigational medication, AXP1275, may be a safe and effective treatment for asthma. The results of this study may help the sponsor to design additional studies.

Read the detailed description

This 2-way, randomized, double-blind crossover study in subjects with mild to moderate atopic asthma is designed to compare the responses to allergen and methacholine challenges within the same subject after approximately 2 weeks of treatment with AXP1275 50 mg or placebo. A total of 20 subjects with asthma with a dual (early and late) asthmatic response to an inhaled aeroallergen will be randomized to 1 of 2 treatment sequences (placebo then AXP1275 or AXP1275 then placebo) in a double-blind fashion to receive either oral AXP1275 or matching placebo, once-daily, for 14 days. The washout period between the 2 treatment periods will be 14 to 21 days.

A post-treatment follow-up visit will occur 14 ± 3 days after completion of the second treatment period.

Conditions
Atopic Asthma
Being tested
AXP1275, AXP1275 matching placebo
Keywords
asthma
Medical subject headings
Asthma

What participants receive

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

  • AXP1275Drug

    AXP1275 50 mg (2 × 25-mg capsules)

  • AXP1275 matching placeboDrug

    AXP1275 matching placebo (2 capsules)

Study groups in NCT01890161
Study groupRoleWhat they receive
AXP1275ExperimentalAXP1275 50 mg (2 × 25-mg capsules) once daily for 14 days
Receives: Drug: AXP1275
AXP1275 matching placeboPlacebo comparatorAXP1275 matching placebo (2 capsules) once daily for 14 days
Receives: Drug: AXP1275 matching placebo

What is being measured

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

  1. Late Asthmatic Response

    Area under the forced expiratory volume in 1 second (FEV1) curve from 3 to 7 hours after allergen challenge (AUC3-7h) on day 13 of both 14-day treatment periods.

    Measured: From 3 to 7 hours after allergen challenge on day 13 of both 14-day treatment periods

Secondary outcomes (10)

  1. Early Asthmatic Response

    Maximum percentage fall in FEV1 and AUC of FEV1 between 0 to 2 hours (AUC0-2h) after allergen challenge on day 13 of both 14-day treatment periods.

    Measured: Between 0 to 2 hours after allergen challenge on day 13 of both 14-day treatment periods

  2. Late Asthmatic Response-Secondary

    Maximum percentage fall in FEV1 between 3 to 7 hours after allergen challenge on day 13 of both 14-day treatment periods.

    Measured: Between 3 to 7 hours after allergen challenge on day 13 of both 14-day treatment periods

  3. Total Asthmatic Response

    Minimum FEV1 and AUC of FEV1 between 0-7 hours (AUC0 7h) after allergen challenge on day 13 of both 14-day treatment periods.

    Measured: Between 0 to 7 hours after allergen challenge on day 13 of both 14-day treatment periods

  4. FEV1 comparison

    For FEV1 values at each time point on day 12, 13, and 14, the difference between the two treatments will be calculated.

    Measured: At day 12, 13, and 14 of both 14-day treatment periods

  5. Sputum eosinophil count

    Induced sputum eosinophil count per mL of sputum on days 12, 13, and 14 of both 14-day treatment periods.

    Measured: On days 12, 13, and 14 of both 14-day treatment periods

  6. Sputum cell count (other)

    Induced sputum cell count per mL of sputum for cells other than eosinophils (including basophils) on days 1, 12, 13, and 14 of both 14-day treatment periods.

    Measured: On days 1, 12, 13, and 14 of both 14-day treatment periods

  7. CCL13 and CCL17 concentrations

    Comparison of the two treatments for changes in sputum concentrations of CCL13 and CCL17.

    Measured: On days 12, 13, and 14 of both 14-day treatment periods

  8. Provocative concentration of methacholine

    Shift in the provocative concentration of methacholine resulting in a 20% reduction in FEV1 (PC20) between days 1 and 12 and between days 12 and 14 of both 14-day treatment periods.

    Measured: Between days 1 and 12 and between days 12 and 14 of both 14-day treatment periods

  9. Maximum exhaled nitric oxide (eNO) and AUC of eNO

    Maximum eNO and AUC of eNO on days 13 and 14 (AUC0-24h) of both 14-day treatment periods.

    Measured: On days 13 and 14 of both 14-day treatment periods

  10. eNO comparison

    For eNO values at each time point on day 13, and 14 of both 14-day treatment periods, the difference between the two treatments will be calculated.

    Measured: On days 13 and 14 of both 14-day treatment periods

Timeline

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

  1. First posted1 Jul 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionApr 2014
  4. Study completionApr 2014

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
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01890161
Sponsor's protocol ID
AXP1275-201
Status last verified
Jan 2016
First submitted
26 Jun 2013
Last updated
5 Feb 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AXP1275 in people with Atopic Asthma, run by Axikin Pharmaceuticals, Inc. at 3 sites in Canada.

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 13 inclusion and 18 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 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. 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. 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?

Late Asthmatic Response (time frame: From 3 to 7 hours after allergen challenge on day 13 of both 14-day treatment periods). 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 NCT01890161.

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 5 Feb 2016.

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