| Indication |
Phase |
Sample Size |
Study
Design/Services |
| Asthma |
2 |
150 |
Randomized,
double-blind, placebo-controlled, five-way crossover study |
| Asthma |
4 |
50 |
Multi-center,
randomized, double blind, positive controlled, parallel group
study |
| Asthma |
3 |
400 |
Randomized,
double-blind, active-controlled, parallel group study |
| Asthma |
3 |
60 |
Single-center,
double-blind, placebo-controlled, crossover study |
| Asthma |
2 |
30 |
Single-center,
double-blind, placebo-controlled, crossover study |
| Asthma |
N/A |
N/A |
Assisted in the preparation of an Investigator
Brochure |
| Asthma |
4 |
|
Completed
numerous post-hoc exploratory statistical analyses and has had
the primary responsibility for writing of several journal
articles and abstracts based on those analyses |
| Asthma |
2 |
40 |
Multi-center,
randomized, double-blind, placebo-controlled, single-dose,
three-period crossover study |
| Asthma |
3b |
25 |
Uncontrolled,
multi-center, open-label study |
| Asthma |
|
|
European
submission; approved by BGA, the German regulatory body |
| Asthma |
NDA |
1000 |
Preparation of a full NDA, including ISS, ISE,
Summary of Risk Benefit, Summary of Statistical Methodology and
other summary sections (Approved) |
| Asthma |
3 |
100 |
Multi-center,
double-blind, randomized, placebo-controlled study |
| Asthma |
1 |
30 |
Randomized,
single-center, multiple-dose, three-period crossover study |
| Asthma |
1 |
25 |
Randomized,
single-center, single-dose, three-period crossover study |
| Asthma |
1 |
10 |
Single-center,
randomized, single-dose, crossover study |
| Asthma |
2 |
60 |
Multi-center,
randomized, double-blind, placebo-controlled, single-dose,
sequential group, dose-escalating study |
| COPD |
2 |
2000 |
Multinational,
randomized, double-blind, placebo- and active-controlled,
parallel group study |
| COPD |
1 |
10 |
Double-blind,
placebo-controlled, single-dose, crossover study |
| COPD |
2 |
400 |
Randomized,
double-blind, placebo-controlled, parallel group study |
| COPD |
2 |
30 |
Single-center,
double-blind, placebo-controlled, crossover study |
| COPD |
2 |
30 |
Single-center,
double-blind, placebo-controlled, crossover study |
| COPD |
2 |
30 |
Single-center,
double-blind, placebo-controlled, crossover study |
| COPD |
2 |
30 |
Single-center,
double-blind, placebo-controlled, crossover study |
| COPD |
1 |
25 |
Double-blind,
placebo-controlled, single-dose, crossover study |
| COPD |
1 |
10 |
Double-blind,
placebo-controlled, single-dose, crossover study |
| COPD |
1 |
25 |
Double-blind,
placebo-controlled, single-dose, crossover study |
| Healthy Subjects (Cystic Fibrosis) |
1 |
30 |
Double-blind,
placebo-controlled, single-center, randomized, two-sequence,
two-period crossover study |
| Moderate and Severe Persistent Asthma |
4 |
400 |
Randomized,
double-blind, multi-center, placebo-controlled, parallel group
study |
