What are clinical trials?

A “clinical trial” (or “clinical research”) is a research study involving patients and volunteers enabling us to answer specific questions related to healthcare. Carefully conducted clinical trials are the quickest and safest way to discover new and effective treatments and therapies.

How can a patient or volunteer benefit by participating in a clinical trial?

It’s true that there are always risks involved in the development of ground-breaking therapies in medicine. Therefore we always have a responsibility to make the patient aware of all possible scenarios and situations. Good research design attempts to maximize benefits and minimize risks.  By carefully designing, executing and supervising trials, researchers try to reduce those risks.

Potential Benefits

  • Playing an active role in our own healthcare.

  • Gaining access to new research treatments before they are widely available.

  • Obtaining expert medical care at leading health care facilities during the trial.

  • Contributing to medical research.

Possible Risks

  • Ineffective treatment

  • Extended time and attention including more trips to the study site

  • More treatments, hospital stays or complex dosage requirements

  • Possible unpleasant, serious or even life-threatening side effects

Who is eligible to participate in a clinical trial?

All clinical trials have guidelines specifying who is eligible to participate. ‘Inclusion’ and ‘exclusion’ criteria are an important principle in medical research that enables us to produce reliable results. The factors that determine eligibility are called “inclusion criteria,” whereas the factors that determine non-eligibility are referred to as “exclusion criteria.” The decision is based on factors such as age, gender, one’s type and stage of a disease, previous treatment history and other medical conditions.

Before joining a clinical trial a participant must qualify for the study. Some research studies seek participants with specific illnesses or conditions, while others simply need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead the criteria are used to identify appropriate participants that will enable safe and accurate research results.

What events take place during a clinical trial?

The clinical trial process depends on the type of research being conducted. The clinical trial team includes doctors, nurses, social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating during the trial, monitor the participant carefully throughout and stay in touch after completion. Some clinical trials involve more thorough tests and doctor’s visits than the participant would normally have for an illness or condition. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

How do we ensure the safety of our participants?

All ethical and legal codes that govern medical practice also apply to clinical trials. In addition most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol: a plan that outlines what researchers will do throughout the study. As a clinical trial progresses researchers report the results of the trial at scientific meetings, to medical journals and to various government agencies. The names of individual participants will remain confidential and will not be disclosed in these reports.

Are these trials regulated?

Every clinical trial in Canada must be approved and monitored by an Institutional Review Board (IRB) to make sure the potential benefits outweigh the anticipated risk. An IRB is an independent committee of physicians, statisticians, community advocates and other healthcare professionals ensuring that a clinical trial is ethical and protects the safety of the participant. All institutions that conduct or support biomedical research involving people must by federal regulation have an IRB approval and be subject to regular reviews.

What are some of the various types of clinical trials?

There is a variety of clinical trials performed today that enable us to effectively treat conditions and prevent disease. Here are some examples of the studies we conduct:

Treatment trials test experimental therapies, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease. During these procedures participants might require medicine, vitamins, vaccines, minerals or lifestyle changes.

Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials test the best way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive Care trials) explore new ways to improve comfort and the quality of life for individuals with a chronic illness.

What is an Allergy? (www.aaaai.com)

An allergy is a chronic condition involving an abnormal reaction to an ordinarily harmless substance called an allergen.

If you have an allergy, your immune system views the allergen as an invader and a chain reaction is initiated. White blood cells of the immune system produce IgE antibodies. These antibodies attach themselves to special cells called mast cells, causing a release of potent chemicals such as histamine. These chemicals cause symptoms such as:

• Itching in the nose, roof of the mouth, throat, eyes
• Sneezing
• Stuffy nose (congestion)
• Runny nose
• Tearing eyes
• Dark circles under the eyes

Allergies are very common. Public health authorities estimate that about 20% of people in North America and Western Europe suffer from some degree of hay fever (allergic rhinitis, allergy to pollen).


What are some of the Allergy symptoms?

Allergy Symptoms can be categorized as mild, moderate, or severe.

Mild Allergy Symptoms

Mild allergy symptoms can include:

  • Rash
  • Localized itching
  • Congestion

Mild allergic reactions do not spread to other parts of the body.

Moderate Allergy Symptoms

Moderate allergic reactions can include symptoms that spread to other parts of the body, including:

  • Widespread itching
  • Difficulty breathing

Severe Allergy Symptoms (Anaphylaxis)

Anaphylaxis is a rare, life-threatening emergency in which the body’s response to the allergen is sudden and affects the whole body. Allergy symptoms may within minutes progress to more serious symptoms, including:

  • Itching of eyes or face
  • Varying degrees of swellings that can make breathing and swallowing difficult
  • Abdominal pain
  • Cramps
  • Vomiting
  • Diarrhea
  • Mental confusion or dizziness

Allergy Treatment

Step 1: Consultation

Your first step is to see a board-certified allergist-immunologist. You may be sent by your primary care physician, follow the recommendation of a family member or friend who is seeing an allergist, or find an allergist certified by the American College of Allergy, Asthma and Immunology (ACAAI) in your area.

Some health plans and HMOs require prior approval to see a specialist. If your request is not immediately honored, ask again and be firm.

Step 2: Testing

Your allergist will obtain a detailed medical history, examine you and evaluate your symptoms. Tests (perhaps lung function tests or x-rays) will be performed to find out the type of your allergic disease. Skin tests or allergy blood tests may be needed to find out the precise causes of your allergic symptoms. Based on the entire clinical evaluation, a diagnosis is made.

If the allergy tests are negative, the allergist can still help find the cause of your symptoms, do not despair. Allergists are also experts in the treatment of non allergic asthma, rhinitis, food and drug reactions, and other types of problems of your immune system, like frequent infections.

Step 3: Treatment

This is the step where your allergic symptoms and you get better. Allergy treatments are of three types: Prevention. Medication. Immunotherapy.

Prevention: Once identified, the cause of the symptoms may be avoided or removed from your life. For example, a particular food can be avoided, or a pet can be removed from the home or kept away from sleeping areas.

Some causes of allergic symptoms, such as pollen, molds and dust mites, cannot be completely eliminated and are difficult to avoid. Exposure can be reduced, however, by environmental control measures prescribed by your allergist.

Medication: Although prevention comes first, more may be needed. Medications are usually used to decrease allergy symptoms and improve the patient’s quality of life, recent advances in medications for asthma and other allergic diseases have been phenomenal. Improvements in drugs have eliminated most of the side effects from older drugs.

The allergy specialist is an expert in the latest safe and effective medications for treating allergic illness.

Immunotherapy (“allergy shots”): If a specific allergy is identified and it cannot be avoided or medications are not sufficient to restore your health, the allergic symptoms may be controlled or eliminated with allergy shots.

Allergy shots have been used since 1911. In the past century, there has been considerable improvement in the effectiveness of this treatment, which decreases a patient’s sensitivity (allergy) to a number of allergens, such as cat or ragweed. The treatment is a method for increasing the allergic patient’s natural resistance (tolerance) to the things that are triggering the allergic reactions.

This treatment involves injections of small amounts of purified “extracts” of the substances that are causing allergic reactions. For example, the extracts may be derived from pollens, mold spores, animal dander, dust mites or insect venom. The U.S. Food and Drug Administration approve them for this use, and over the years they have been improved considerably.

Allergy shots stimulate the immune system to fight allergies safely, effectively and naturally. Beginning with small doses and increasing them gradually on a weekly or biweekly basis, the therapy continues until a maintenance level is achieved. Then, a maintenance dose is injected every few weeks.

Immunity does not occur immediately, but some patients do begin to feel better quickly. Most patients are continued on monthly injections for 3 to 5 years once they reach the maintenance dose. In some patients, immunity is maintained and treatment can be stopped after several years. For others, treatment may be needed for longer periods of time. Generally the benefits of allergy shots can last for many years, or even a lifetime.

With the immune system restored to good health, few or no medications may be needed. Work or school days are no longer missed. The burden of allergies is lifted, and allergies become something you just don’t think about any more. Candidates for allergy shots include most children and adults. Pregnant patients can continue treatment that was started prior to pregnancy.

Allergy shots are prescribed by an allergist and are always given under medical supervision at a location where medical staff and medications are available to handle any serious reaction. Although rare, serious reactions can occur from allergy shots because the treatment involves the substances to which the patient is known to be allergic.

Adverse reactions can occur from allergy shots because treatment involves the injection of substances to which the patient is sensitized. The most common adverse reaction is an immediate red, itching bump at the injection site. In some cases, a similar delayed reaction can occur six to twenty-four hours later. Rare, more severe reactions include generalized itching, chest tightness/wheezing, or dizziness due to a drop in blood pressure. Deaths have been reported from allergy shots at a rate of approximately one in three million injections. This is why allergy shots are given under supervision where medical staff and medications are available to handle serious reactions. As allergists, we feel that the benefits far outweigh the extremely small risk of a serious reaction. It is safe for both children and adults, and even pregnant patients may continue treatment started prior to pregnancy.

Source: http://www.acaai.org/allergist/allergies/Treatment/Pages/default.aspx


What is Allergen-specific immunotherapy or allergy shots?

Allergen-specific immunotherapy (also known as allergy shots) is an effective treatment used by allergists and immunologists for common allergic conditions, particularly allergic rhinitis/conjunctivitis, allergic asthma and stinging insect hypersensitivity [1-4]. This form of therapy typically involves the subcutaneous administration of gradually increasing quantities of the patient’s relevant allergens until a dose is reached that is effective in inducing immunologic tolerance to the allergens. The primary objectives of allergen-specific immunotherapy are to decrease the symptoms triggered by allergens and to prevent recurrence of the disease in the long-term. Currently, it is the only identified disease-modifying intervention for allergic disease[5,6].

Source: http://www.aacijournal.com/content/7/S1/S5



Allergen-specific immunotherapy is indicated in patients with allergic rhinitis/conjunctivitis and/or allergic asthma who have evidence of specific IgE antibodies to clinically relevant allergens. Skin prick testing (SPT) is the preferred method of testing for specific IgE antibodies. Allergen-specific IgE testing which provides an in vitro measure of a patient’s specific IgE levels against particular allergens is a reasonable alternative to SPT. However, SPTs are generally considered to be more sensitive and cost effective than allergen-specific IgE tests. Patients with allergic rhinitis/conjunctivitis or allergic asthma who may be good candidates for immunotherapy include those who: have symptoms that are not well controlled by pharmacological therapy or avoidance measures; require high doses of medication, multiple medications, or both to maintain control of their disease; experience adverse effects of medications; or wish to avoid the long-term use of pharmacological therapy.

Source: http://www.aacijournal.com/content/7/S1/S5


Allergic rhinitis

Allergen immunotherapy is an effective treatment for allergic rhinitis, particularly for patients with intermittent (seasonal) allergic rhinitis caused by pollens [5,8] It has also been shown to be effective for the treatment of allergic rhinitis caused by tree pollen, grass pollen and ragweed pollen, house dust mites, cat and dog dander, alternaria, and cockroach. Often patient’s symptoms improve even when they were resistant to conventional drug therapy.

Evidence suggests that at least 3 years of allergen-specific immunotherapy provides beneficial effects in patients with allergic rhinitis that can persist for several years after discontinuation of therapy. In Canada, most allergists consider stopping immunotherapy after 5 years of adequate treatment. Immunotherapy may also reduce the risk for the future development of asthma in patients with allergic rhinitis.

Source: http://www.aacijournal.com/content/7/S1/S5



Immunotherapy has been shown to be effective against allergic asthma caused by grass, ragweed, house dust mites, cat and alternaria. A Cochrane review of 75 randomized controlled trials examining the use of allergen-specific immunotherapy in asthma management confirmed its efficacy in reducing asthma symptom scores and medication requirements, and improving airway hyperresponsiveness. Similar benefits have been noted with sublingual immunotherapy, which is expected to be approved in Canada in the near future. Evidence also suggests that allergen-specific immunotherapy may prevent the onset of asthma in atopic individuals. One study in children with grass and/or birch pollen allergy found that only 26% of subjects treated with immunotherapy developed asthma 3 years after completion of treatment compared to 45% who were not treated with immunotherapy. Allergen-specific immunotherapy may also modify the progression of established asthma in children. A study published in the 1960s found that 70% of treated children no longer had asthma 4 years after completing immunotherapy compared to 19% of untreated control subjects, and these results were sustained up to 16 years of age. However, there is no current evidence that immunotherapy influences the evolution of established asthma in adults.

Source: http://www.aacijournal.com/content/7/S1/S5

What is asthma?

Asthma is a chronic (long-term) disease that makes it hard to breathe. Asthma can’t be cured, but it can be managed. With proper treatment, people with asthma can lead normal, active lives.

If you have asthma, your airways (breathing passages) are extra sensitive. When you are around certain things, your extra-sensitive airways can:

Become red and swollen - your airways get inflamed inside. They fill up with mucus. The swelling and mucus make your airways narrower, so it’s harder for the air to pass through.

Become “twitchy” and go into spasm - the muscles around your airways squeeze together and tighten. This makes your airways narrower, leaving less room for the air to pass through.

The more red and swollen your airways are, the more twitchy they become.

Source: http://www.lung.ca/diseases-maladies/asthma-asthme/what-quoi/index_e.php


What sets off your asthma symptoms?

Many different things can set off your asthma symptoms. Each person with asthma has her own set of asthma inducers and asthma triggers.

Asthma inducers: If you breathe in something you’re allergic to- for example, dust or pollen- or if you have a viral infection- for example, a cold or the flu- your airways can become inflamed (red and swollen).

Asthma triggers: If you breathe in an asthma trigger like cold air or smoke, or if you exercise, the muscles around your airways can go into spasm and squeeze together tightly. This leaves less room for air to pass through.

It’s important for every person with asthma to know what they triggers and inducers are, so they can avoid them.

What causes asthma? Who is at risk of getting it?

Doctors know that there are some things that make a person more likely to get asthma:

Family history: if people in your family have allergic diseases like asthma, hay fever (allergic rhinitis), or eczema, there is a higher chance you will have asthma.

Air pollution indoors and outdoors: some research shows that people who live near major highways and other polluted places are more likely to get asthma. Also, kids who grow up in a home with mould or dust may be more likely to get asthma.

Work-related asthma (occupational asthma): People who work in certain types of jobs can get asthma from things they work with. For example:

  • Laboratory workers can get asthma from lab animals: rats, mice, guinea-pigs
  • Spray painters can get asthma from isocyanates
  • Grain handlers can get asthma from grain dust
  • Crab processors can get asthma from crab dust

Learn more about work-related asthma, including occupational and work-exacerbated asthma. In our section on work-related asthma, we explain who is at risk for work-related asthmasigns and symptoms of work-related asthma, and more.

Second-hand smoke: Kids whose mothers smoked while pregnant, who grow up in a smoky house, or whose grandmothers smoked, are all more likely to get asthma.

Source: http://www.lung.ca/diseases-maladies/asthma-asthme/what-quoi/index_e.php

Allergies and asthma

Many people with asthma have allergies that make their asthma worse. If you have asthma, it’s important to:

Allergies in people with asthma

Anybody can get allergies, even people who do not have asthma. But people with asthma and allergies will have a reaction in their airways in addition to the ususal allergy symptoms (itchy, watery eyes etc.)

If you have asthma, allergens can make your airways red, swollen, and filled with sticky mucus. Your airways react as soon as you’re near the allergen, and also a little while later:

Right away, you can have symptoms like wheezing and feeling short of breath. Your airways are extra-sensitive, and they can tighten as soon as you start breathing in allergens. These first symptoms can usually be relieved by a rescue inhaler (usually a blue puffer, for example, Ventolin©).

A few hours after you breathe in the allergen, you can feel a second wave of symptoms. These symptoms are caused by your airways gradually swelling (inflammation). Because there’s a delay before people feel this kind of symptom, it can be hard to recognize what it was that brought on the reaction. Taking an asthma preventer medicine (for example, an inhaled corticosteroid) on a regular basis will help to prevent this reaction from happening and will help to treat the inflammation when it does happen

Source: http://www.lung.ca/diseases-maladies/asthma-asthme/what-quoi/index_e.php


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