DUAKLIR PRESSAIR SIDE EFFECTS
- Generic Name: aclidinium bromide and formoterol fumarate inhalation powder
- Brand Name: Duaklir Pressair
- Drug Class: Respiratory Inhalant Combos, Respiratory Inhalant Combos
SIDE EFFECTS
LABAs, such as formoterol fumarate, one of the active ingredients in DUAKLIR PRESSAIR, increase the risk of asthma-related death. DUAKLIR PRESSAIR is not indicated for the treatment of asthma.
The following adverse reactions are described in greater detail elsewhere in the labeling:
- Paradoxical bronchospasm.
- Immediate hypersensitivity reactions.
- Cardiovascular effects.
- Worsening of narrow-angle glaucoma.
- Worsening of urinary retention.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical program for DUAKLIR PRESSAIR included 6501 subjects with COPD in 2 placebocontrolled and 1 active-controlled 24-week lung function trials, one long-term safety extension study of 28 weeks and 2 other clinical trials. A total of 1893 subjects have received at least 1 dose of DUAKLIR PRESSAIR.
24-Week Trials
The frequency of common adverse reactions in Table 1 below is based upon pooled data from two, double-blind, placebo-controlled parallel group clinical trials (Trials 1 and 2, n=1729 and n=1669) in 3398 adult patients with moderate to severe COPD. Of these, 60% were male and 94% were Caucasian. They had a mean age of 64 years and an average smoking history of 46 pack-years, with 49% identified as current smokers. At screening, the mean post-bronchodilator percent predicted forced expiratory volume in 1 second (FEV1) was 54% (range: 28% to 80%) and the mean percent reversibility was 15% (range: -19% to 69%).
Table 1 shows all adverse reactions that occurred with a frequency of greater than or equal to 3% in the DUAKLIR PRESSAIR group in the two 24-week placebo-controlled trials where the rates in the DUAKLIR PRESSAIR group exceeded placebo.
Table 1: Adverse Reactions with DUAKLIR PRESSAIR ≥3% Incidence and More Common than with Placebo in Subjects with COPD
| Adverse Reactions Preferred Term | Treatment | |||
| DUAKLIR PRESSAIR (N=720) % |
Aclidinium (N=722) % |
Formoterol (N=716) % |
Placebo (N=526) % |
|
| Upper respiratory tract infectiona | 8.9 | 7.6 | 8.9 | 6.3 |
| Headache | 6.3 | 6.6 | 7.7 | 5.1 |
| Backpain | 3.8 | 3.3 | 3.5 | 3.4 |
| aIncludes Viral Upper Respiratory Tract Infection and Upper Respiratory Tract Infection | ||||
Other adverse reactions reported in clinical studies with an incidence of >1% but less than 3% with DUAKLIR PRESSAIR but more common than with placebo were cough, sinusitis, influenza, tooth abscess, insomnia, dizziness, dry mouth, oropharyngeal pain, muscle spasms, musculoskeletal pain, arthralgia, pain in extremity, urinary tract infection, and blood creatine phosphokinase increased.
The adverse events reported in the 24-week active-controlled trial were consistent with those observed in 24-week placebo-controlled trials.
Long-Term Safety Extension Trial
In a 28-week safety extension trial, 918 subjects who successfully completed Trial 2 were treated for up to an additional 28 weeks for a total treatment period of up to 52 weeks with DUAKLIR PRESSAIR, aclidinium 400 mcg, formoterol fumarate 12 mcg administered twice daily or placebo. Because the subjects continued from Trial 2 into the safety extension trial, the demographic and baseline characteristics of the long-term safety extension trial were similar to those of the placebocontrolled efficacy trials described above. The adverse reactions reported in the long-term safety trial were consistent with those observed in the 24-week placebo-controlled trials.
SRC: NLM .