Pharm-Olam International - A Contract Research Organization

Pediatric Asthma (Rescue)

Pharm-Olam rescued this study by recruiting 197 patients from 12 sites in Poland in 2.5 months, allowing our sponsor to meet their enrollment target on time. This Phase III double blind, placebo controlled study used a metered dose inhaler once daily for 12 weeks in treatment of children with persistent asthma.

Pharm-Olam selected the sites, recruited patients, and handled regulatory affairs for the sponsor.

"The recruitment challenges were considerable based on the required age and inclusion/exclusion criteria of participants.

In order to obtain the necessary number of patients, we asked Pharm-Olam to basically double their enrollment numbers half way through the trial and still meet the original times. The team successfully met this challenge."

Manager, Respiratory Medicine (Pediatric Asthma Study)

Rhinoconjunctivitis (Cat Allergy)

Pharm-Olam conducted a rhinoconjunctivitis study for a desensitizing vaccine using 2 sites in Western Europe. Recruitment closed on time, with 88 randomized patients in 22 weeks. This study involved multiple cohorts, escalating doses, and Late-Phase Allergic Skin Reaction (LPSR) measurement. Services provided to the sponsor included regulatory, project management, monitoring, data management, and biostatistics.

Seasonal Allergic Rhinitis (Bioequivalence)

Pharm-Olam conducted a full service study in Seasonal Allergic Rhinitis involving 30 sites. A total of 580 patients were randomized (20 over target) in 3.7 months. Enrollment objectives were met on time despite screening holds due to availability of sponsor’s drug, revisions in ICF, unusually long winter, excessive rain, and hurricane/tornadoes near some site locations.
The bioequivalence study involved a 7-day single-blind placebo lead-in phase, use of comparator and placebo. Assessment methods involved TNSS, rhinoscopy, and patient e-diaries.

Environmental Exposure Units

Planning allergy studies can be very challenging because of variable weather, pollen variance among site locations, indoor/outdoor lifestyle of patients, study medication compliance, and limited enrollment periods.

The use of Environmental Exposure Units (EEU) can help sponsors address these variables through strictly controlled conditions. This includes variables for air quality, temperature, humidity, and precise maintenance of allergen concentration. In the US FDA’s “Draft Guidance for Industry: Allergic Rhinitis: Clinical Development Programs for Drug Products” EEU studies are recognized as systems for evaluation of onset of action of anti-allergic medications and prophylactic treatment for seasonal allergic rhinitis (SAR).

Pharm-Olam has experience working with EEUs in North America and Europe, including Queen's University; Kingston General Hospital EEU in Canada which has over 20 years of EEU research experience.

FDA Guidance Documents


		Allergic Rhinitis: Clinical Development Programs for Drug Products Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment

Respiratory and Allergy Studies

Asthma
Biomarkers in Smokers
Cat Allergy
Emphysema
Grass Allergy
Otitis Media
Pulmonary Hypertension
Ragweed Allergy
Rhinitis, Perennial
Rhinitis, Seasonal
Rhinoconjunctivitis
Respiratory Distress Syndrome
Tuberculosis
Upper Respiratory Infections

Allergy Resources

Europe

Pollinfo.org

SILAM - Birch

SILAM - Grass

North America

AAAAI.org

Argentina (Buenos Aires), Belarus (Minsk), Belgium (Brussels), Brazil (São Paulo), Bulgaria (Sofia), Canada (Toronto), Croatia (Zagreb), Czech Rep. (Prague), Georgia (Tbilisi), Germany (Munich), Hungary (Budapest), India (Bangalore), Italy (Milan), Kazakhstan (Almaty), Mexico (Mexico City), Poland (Warsaw), Romania (Bucharest), Russia (Moscow, St. Petersburg, Novosibirsk), Serbia (Belgrade), Spain (Madrid), South Africa (Johannesburg), Ukraine (Kiev), United Kingdom (London), United States (Houston, Princeton, Research Triangle Park)