AIR-CF1 Study | CAYSTON® (aztreonam for inhalation solution)
Exploring how CAYSTON may help improve respiratory symptoms and lung function
AIR-CF1 was the main clinical study for CAYSTON. The goals of the study were to look at improvement in respiratory symptoms and lung function, as measured by change in FEV1 x FEV1 (Forced Expiratory Volume) measures the amount of air that can be forcefully blown out in 1 second after taking a deep breath. Your doctor will give you a pulmonary function test to measure your FEV1. at Day 28.
Who was in the study?
164 people aged 7+ diagnosed with cystic fibrosis (CF) and
Pseudomonas aeruginosa (Pa)
lung infection, with a FEV1% predicted
of 25%–75%.
80 people treated with CAYSTON
3x a day for 28 days
84 people treated with placebo*
3x a day for 28 days
People in the study used an inhaled bronchodilator (a medicine used
to relax and open your airways) prior to taking CAYSTON or placebo.
*
The people in the study were not told whether they were being treated
with CAYSTON or a placebo (a solution with no medication in it)
with the ALTERA® Nebulizer System.
How long was the study?
- The study lasted 42 days
- People in the study were on treatment from Day 0 to Day 28
- People in the study were off treatment from Day 29 to Day 42
How respiratory symptoms were measured
The Cystic Fibrosis Questionnaire-Revised (CFQ-R)
The CFQ-R is a survey made specifically for people with CF. Doctors used the respiratory section of the CFQ-R survey with people in the study to track if symptoms such as wheezing, coughing, and mucus production got better or worse.
What type of questions were asked in the CFQ-R?†
- Have you been congested?
- Have you had to cough up mucus?
- Have you been coughing during the day?
- How often during the past 2 weeks have you been wheezing?
- How often during the past 2 weeks have you had trouble breathing?
- How often during the past 2 weeks have you awakened during the night because you were coughing?
†
These questions are from the CFQ-R version for people 14 years
and older; younger children used a different questionnaire or a
parent questionnaire was used.
CFQ-R was used to measure respiratory symptoms. Responses were tracked at the beginning of the study, Day 14, Day 28, and 2 weeks after the treatment ended.
Surveys gather information by asking people questions in a reliable and valid way. Reliable means the same results can be gathered over and over. Valid means the survey measures what it is supposed to. When surveys ask questions based on personal opinions or experiences, however, the information can be misinterpreted and the results might not be reliable and valid.
CAYSTON helped people breathe better
9.7-point improvement
in breathing symptoms was reported in CFQ-R
responses after 28 days
of taking CAYSTON, compared to a placebo.
Two weeks after treatment ended (Day 42), people in the study still reported a statistically significant improvement (meaning the improvement was likely caused by something other than chance) in their wheezing, coughing, and mucus production compared to those who took a placebo, though the difference was smaller (6.3 points).‡
Statistically significant improvements in breathing symptoms were seen in both adults and children ≥7 years of age, but were smaller in adults.
- While the full Prescribing Information for CAYSTON includes results on changes in breathing symptoms, it does not mention the changes in CFQ-R scores
- Changes in the CFQ-R scores reported in this study cannot be directly attributed to changes in lung function
‡
Based on CFQ-R responses.
I really noticed a difference in my respiratory symptoms after 28 days on CAYSTON…when I'm on CAYSTON, I don't wheeze or cough up as much sputum.”
Individual results may vary.
CAYSTON helped improve lung function
To measure the change in FEV1, everyone in the study took a pulmonary
function test at the beginning of the study, Day 14, Day 28,
and 2 weeks after treatment ended.
Average 10% improvement in FEV1
was seen after 28 days compared to placebo
§
Adjusted mean change from baseline.
After 28 days, people who took CAYSTON had an average 10% increase in their starting FEV1 (L) compared with people in the placebo group.
This difference decreased to about 6%, 2 weeks after the treatment ended.
When I'm on CAYSTON, I notice a positive difference in my coughing and see a boost in my lung function.”
Individual results may vary.
It’s so important for the Pa medication to improve his FEV1—it gives you the encouragement to keep going.”
Individual results may vary.
Common side effects
Common side effects experienced by people taking CAYSTON include:
- Coughing
- Nasal congestion
- Wheezing
- Sore throat
- Fever (may be more common in children than in adults)
- Chest discomfort
- Stomach area (abdominal) pain
- Vomiting
Tell your doctor if you have any new or worsening symptoms while taking CAYSTON and about any side effects that bother you or that do not go away. These are not all the possible side effects of CAYSTON. For more information, ask your doctor or pharmacist.
Ask your doctor if cayston is right for you
